Infant formula, like breast milk, can be your baby’s primary source of nutrition. Though manufacturers can implement strict safety measures, there are times when contamination or safety issues happen.
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Contaminated baby food and infant formula can be dangerous to your child’s health. It might even cause death in severe cases.
That’s why it’s important to monitor any safety alerts or recalls on infant formula products.
Have there been any formula recalls or baby food recalls in 2022?
Yes. There have been several formula and baby food recalls in 2022 and in past years. These include several popular brand names. The recalls worsened the formula shortage.
So, which products were affected by the formula recalls, and why were they recalled? Have there been recalls for European formulas, too?
List Of Formula Recalls
- Similac and Pedialyte Ready-to-Feed Liquid Products
- Similac, Alimentum, and EleCare (first Similac recall 2022)
- Similac PM 60/40 (second Similac recall 2022)
- Angel formula recall (2022)
- Able Groupe formula recall (2021) for HiPP, Holle, Kendamil, and Bioland (Lebenswert)
- Designed by Nature formula recall (2021)
- SMA Wysoy formula recall – UK (2021)
- Kirkland Signature Brand by Costco, Non-GMO Formula For Babies Sensitive To Lactose formula recall – Canada (2019)
- Calcilo XD formula recall (2019)
- Similac TummiCare One formula recall – Philippines (2019)
- Parent’s Choice Advantage infant formula recall (2019)
- Bebe Mandorle Stage 2 (Bio) formula recall (2018)
- Dumex Mamil Gold (Step 1) infant milk formula recall – Singapore (2018)
- Lactalis Nutrition Santé (LNS) formula recall (2017)
- Sammy’s Milk Baby Food – formula recall (2016)
- Similac powdered infant formula recall (2010)
- Similac Special Care Ready-to-Feed Premature Infant Formula with Iron recall (2007)
- Similac Liquid Ready-To-Drink Formulas – Similac Advance With Iron and Similac Alimentum recall (2006)
- Enfamil formula recall – Gentlease (2006)
- Similac Advance with Iron Formula Powder recall (2005)
- Mead Johnson EnfaCare LIPIL formula recall (2003)
- Enfamil Nutramigen formula recall (2001)
Safety Issues & Store Recalls
- Nutricia KetoCal 3:1 tested positive for Cronobacter (2022)
- Enfamil powder formula tampering (2019)
- Milupa Aptamil 1 Pronutra – store recall In Slovenia (2018)
- Enfamil Formulas – CVS store recall (2018)
- Enfamil AR – possible product tampering (2018)
- Gerber Good Start Soy Formula – possible product tampering (2017)
- Enfamil Newborn – store recall (2011)
Find out more about these recalls and tampering issues below.
Abbott Nutrition Recalls Ready-to-Feed Liquid Products
Update: October 16, 2022
Abbott Nutrition voluntarily recalled certain lots of ready-to-feed (2 fl oz or 59 ml bottles) liquid products due to a manufacturing defect. Some of the bottles from the recalled lots might have bottle caps that weren’t sealed completely, resulting in possible spoilage. (1)
These products were manufactured by their facility in Columbus, Ohio. (1)
According to the recall advisory, your baby can experience diarrhea, vomiting, and gastrointestinal symptoms if they are fed with these spoiled products. (1)
Affected ready-to-feed products: (1)
- Similac 360 Total Care
- Similac 360 Total Care Sensitive
- Similac Pro-Total Comfort
- Similac Special Care 24
- Similac Stage 1
- Similac NeoSure
- Similac Water (Sterilized)
- Pedialyte Electrolyte Solution
Abbott Nutrition clarified that this recall only includes “a small percentage” of the ready-to-drink bottles distributed to some hospitals, doctor’s offices, retailers, and distributors in these areas: (1)
- Puerto Rico
- Dominican Republic
- Trinidad & Tobago
- St Thomas
- St Croix
Abbott Nutrition clarifies that this recall only affects certain products and specific bottle lots or case/carton numbers. (Read our Similac recall article for the list of affected lots)
Don’t feed any of these recalled products to your baby.
Call Abbott Nutrition for more information:
- US: 1-800-986-8540
- Puerto Rico: +1 787-622-5454
Alternatives To Recalled Baby Formulas (From The Shortage & Beyond)
Update: July 22, 2022
Amid the formula shortage following issues hounding suppliers earlier this year, including the massive Similac recall, many parents continue to face difficulties in finding products for their little ones.
Here are some baby formulas for you to try (US brands), with your doctor’s approval:
- Bobbie Organic Infant Formula
- Serenity Kids A2 Toddler Formula (Use our code MHC for 15% off first-time orders, too!)
- ByHeart Baby Formula
You can also consider the following European formulas, which could be the best organic options for your baby:
IMPORTANT: Please consult your healthcare provider or pediatrician before switching to any of these formulas. Many of these European formulas aren’t approved by the FDA, but many parents still prefer them over US brands.
Formula Recall 2022
Abbott Plant Finally Reopens After Flooding
Update: July 10, 2022
After a three-week shutdown due to damage from the floods in the area, the Abbott plant in Sturgis, Michigan, has finally reopened again. Abbott announced that they reopened on July 1, 2022 and would restart EleCare production followed by specialty and metabolic formulas. (2)
FDA To Allow Overseas Formulas Beyond Shortage
The FDA plans to allow the import of overseas formulas from temporary suppliers to go beyond the shortage to prevent it from happening again. (3)
The federal agency announced that it will issue further guidance about this in September, and detail how these companies could meet requirements to continue supplying infant formulas beyond the original end date of mid-November. (3)
FDA Probes Another Abbott Formula-related Infant Death
Update: June 22, 2022
FDA officials announced that they received a new report of another formula-related infant death last June 10. (4)
The baby reportedly consumed infant formula made by Abbott Nutrition. The FDA is now investigating the infant death which reportedly happened in January. (4)
US To Import 16 Million 8-oz Baby Formula Bottles From Mexico
With Abbott’s Sturgis plant still closed, US officials scramble to bring more formulas from facilities across the world whose products meet US standards.
The White House recently announced the tenth flight of Operation Fly Formula which will bring around 1 million pounds (equivalent to approximately 16 million 8-oz bottles) of Gerber Good Start Gentle infant formula from Mexico. (5)
The formulas will arrive in Fort Worth, Texas starting on June 24. (5)
Newly Reopened Abbott Plant Closes Again Due To Flooding
Update: June 19, 2022
Troubles continue to hound Abbott Nutrition as its Sturgis plant closes again just days after reopening due to floods affecting the area. (6)
Severe thunderstorms hit Michigan, resulting in power outages and flood damage, including areas of the Abbott plant. The company has informed the FDA of the new setback and announced that production will likely be delayed for a few weeks. (6)
They will conduct comprehensive testing with an independent third party to ensure the plant’s safety. EleCare production will resume after re-sanitization and the FDA’s approval to resume production. (6)
More Formulas Arrive From Across The World
President Joe Biden’s “Operation Fly Formula” facilitated the fast shipment of more formulas from across the world to help solve the formula shortage.
In the middle of June, as many as 95,000 cans of baby formula arrived in LAX from Australia for Albertsons Companies, Walmart, and The Kroger Company grocery stores. (7)(8)
Two shipments of Bubs formula from Australia brought 380,000 lbs of infant formula equivalent to approximately 4 million eight-ounce bottles. (8)
The US also received 200,000 8-ounce bottles of Kendamil formula at Dulles International Airport in Virginia. It’s a shipment from the United Kingdom. More Kendamil formula cans will arrive on three more flights in the coming weeks. (9)
Also in the middle of June, 44,000 pounds (equivalent to approximately 548,000 eight-ounce bottles) of Nestlé Health Science Alfamino and Alfamino Junior (both are specialty infant formulas) arrived at the Louisville International Airport from Switzerland. (8)
Abbott will also import Similac NeoSure (for premature and low birthweight infants) and Similac Total Comfort (for babies with sensitive tummies) beginning in June from their manufacturing facility in Granada, Spain. (6)
The shipments will include 686,350 cans equivalent to around 16.5 million 8 fl oz bottles of formula. (6)
In July, around 750,000 cans of Danone formula equivalent to 19 million 8-ounce bottles will arrive from the company’s manufacturing facility in Ireland. (9)
The first shipment will be Aptamil First Infant Milk Stage 1, a formula designed for healthy babies. It isn’t ideal for premature babies or those with metabolic and digestive issues. (9)
Recalled Baby Formula Products Accidentally Sold In Canada
The CFIA (Canadian Food Inspection Agency) warned consumers in Canada who bought a formula item from Shoppers Drug Mart to check if their products were part of the February 2022 Similac recall. (10)
According to the government agency, the recalled Abbott products were accidentally sold due to an “online error.” (10)
Anyone who bought Abbott formula from the retail pharmacy giant should check for the following codes that indicate the products were recalled in February 2022:
- The expiration date code starts from 4-1-2022 (APR 2022)
- The first two digits are a number from 22 to 37
- The code has K8, SH, or Z2
The codes are found at the bottom of the package or container.
These products shouldn’t have been sold to consumers at all. So, the store announced a secondary recall of these recalled infant formulas. (10)
Nine Formula-related Baby Deaths Reported To FDA During Abbott Investigation
Update: June 10, 2022
The FDA reportedly received a total of nine reports of formula-related baby deaths from December 1, 2021 to March 3, 2022. Two of these baby deaths were among four confirmed Cronobacter sakazakii infections that led to the Similac recall in February. (11)
Although none of the DNA sequences in the FDA investigations matched the company’s products, all these babies were fed Abbott powdered formula: (11)
- Similac Pro-Total Comfort (Powder) infant formula
- Similac Advance
- Similac Total Comfort Easy-to-Digest Gentle Protein & Prebiotics
- Similac PM 60/40
- EleCare infant formula
- Similac Pro Advance infant formula
Abbott Reopens Sturgis Plant, Starts EleCare Production
Update: June 6, 2022
On June 4, 2022, Abbott Nutrition finally restarted its facility in Sturgis, Michigan, which was the center of the massive Similac recall announced back in February. (12)
The company will prioritize producing EleCare and other specialty or metabolic formulas for babies with severe food allergies or digestive problems. These formulas are expected to hit market shelves by June 20.
Abbott will also restart the production of Similac and other formulas as soon as possible.
The plant’s reopening is expected to help improve formula supplies in the market and, hopefully, solve the formula shortage problem soon.
Foreign Companies Help As US Formula Shortage Hits 70%
Update: May 31, 2022
Retail data firm Datasembly announced that the out-of-stock rates have gone up to as high as 70% across the US as of the week ending May 22. (13)
In response to Biden’s call for help, several foreign baby formula companies announced that they were going to ship products to the US, especially after the FDA also assured them that some regulations will be relaxed to solve the crisis.
Bubs Australia announced that it will send at least 1.25 million cans of baby formula to the US, while also assuring Australian parents that they have enough stocks for everyone. (14)
UK manufacturer Kendal Nutricare, the makers of Kendamil, said that it will send formulas to fill around 100 trucks over the next six months. (15)
Babies Hospitalized In The US Due To The Formula Shortage
Update: May 23, 2022
In various parts of the US, several babies, including some older children, have been hospitalized due to the formula shortage.
Two Children Hospitalized In Tennessee
At least two children in Tennessee have been hospitalized because their specialty formula is out of stock.
According to Dr. Mark Corkins, a pediatric gastroenterologist at Le Bonheur Children’s Hospital in Memphis, Tennessee, he admitted the two patients (a toddler and a preschooler) because they ran out of EleCare. (16)
Both children have short bowel syndrome and couldn’t absorb full-size proteins. They relied on EleCare, a specialty formula, for nourishment because it was made of amino acids, which are building blocks of proteins. These amino acids don’t have to be digested.
After the EleCare recall, however, these kids had to try other formula options. Unfortunately, they were unable to tolerate the new formulas and suffered from dehydration. (16)
Dr. Corkins said that the preschooler has been admitted since April and is still at the hospital as of press time, while the toddler was only hospitalized for around a week.
He explained that these kids were otherwise healthy and could have stayed at home, but they had to be hospitalized just to get nourishment.
Babies Hospitalized In South Carolina For Intolerance & Mineral Imbalances
Aside from these two children in Tennessee, at least three babies have been hospitalized in South Carolina because of intolerance after their parents or caregivers gave them other formulas due to the shortage. (17)
The kids were admitted to the Medical University of South Carolina Shawn Jenkins Children’s Hospital in Charleston, South Carolina.
Another child was hospitalized due to mineral imbalances after taking formula mixed at home by their caregiver. (17)
Undisclosed Number Of Kids Hospitalized in Georgia
At the Children’s Healthcare of Atlanta in Georgia, an undisclosed number of children with complex medical issues have been hospitalized for malnutrition since February, shortly after the Abbott plant was closed. (18)
The hospital’s spokesperson didn’t disclose the exact number of hospitalized kids but said that they all had specific dietary needs. So, any changes to their formula have to be carefully monitored for tolerance or they could end up getting sick. (18)(19)
However, finding a suitable formula can be a difficult process for these children. The doctors have to make sure that the new formula can meet their nutritional needs while also ensuring it doesn’t trigger a potentially dangerous reaction, such as dehydration or diarrhea.
According to the spokesperson, they admitted babies to older children. Thankfully, have all been discharged. (18)
Undisclosed Number Of Kids Hospitalized in Wisconsin
Children’s Wisconsin also had treated an undisclosed number of children, according to Jennifer Crouse, the Clinical Nutrition Manager. (19)
Some of the children suffered malnutrition due to homemade formula and other inappropriate substitutions. Many also had malnutrition, again, due to the lack of formula access. (19)
WARNING: Children’s Wisconsin warns that giving your baby homemade formula can lead to liver and/or kidney damage. It might even cause an imbalance in their body that could cause their heart to stop. (19)
Dr. Crouse also warns against giving watered-down formulas to stretch your supply. Formula dilution can lead to serious complications, including organ failure and brain swelling. (19)
If you can’t find your baby’s regular formula, she recommends asking your pediatrician before choosing any type of substitute.
Defense Production Act Invoked To Address Shortage
As the baby formula shortage continues to rage in the US, US President Joe Biden invoked the Defense Production Act to help address the problem. (20)
Suppliers are required to prioritize orders from baby formula manufacturers under this act. (20)
The first authorizations issued are “priority orders” for top formula makers Reckitt Benckiser (Enfamil) and Abbott Nutrition (Similac): (21)
- For Abbott Nutrition – raw materials (e.g. sugar and corn syrup)
- For Reckitt – single-use products (e.g., filters needed to generate oils)
It’s estimated that production can increase to about one-third for Abbott (once the Sturgis plant resumes production) and to maximum capacity for Reckitt facilities once these shipments are received. (21)
“Operation Fly Formula” To Get Stocks From Overseas
With Abbott’s plant still closed, the newly ramped up formula production plans aren’t expected to quickly solve the shortage. So, Biden also launched “Operation Fly Formula” to get stocks from overseas. (20)
Various government agencies were told to use the Department of Defense military planes to get formula overseas and fly these to the US. The formulas need to meet US standards.
Regular formula shipments take around two weeks to reach the US, but they’re now expected to arrive within just 72 hours with these special flights. (17)
European Stocks To Help With US Shortage
The Biden administration had previously announced that they will import formulas as one of the measures to help ease the US shortage. (22)
Formula makers like Nestle were quick to respond. The brand readied Alfamino and Gerber Good Start Extensive HA. (23)
Both products serve a critical medical purpose because they’re especially formulated for babies with cow’s milk protein allergies.
It was easier to increase the shipments from Europe because both products were already being imported to the US even before the shortage, the Nestle representative explained. (23)
The brand has also increased production and announced that they’re “working round the clock” to help solve the shortage and meet the increased demands. (21)
To further increase the market supply in the US, the company representative added that they’re checking for ways to tap into the Nestle global nutrition network to import other formulas.
This came after the FDA announced that formula companies are given temporary flexibility for importing infant formulas to help address the shortage. (23)
To speed this up, the FDA added that it’s updating the review process so that more foreign manufacturers will ship their products to the US. Boosting imports can greatly help bring more formulas to restock empty supermarket shelves. (23)
First European Shipment Arrives
As promised by Biden and Nestle, “Operation Fly Formula” was able to bring the first batch of formulas (78,000 lbs) to supply specialty infant formula. (21)
According to director Brian Deese of the White House National Economic Council, the military cargo plane (from the Air Force cargo) carried 15% of the US’s demand for specialty medical-grade baby formula.
It carried a total of 132 pallets of Nestle Health Science Alfamino Infant and Alfamino Junior formulas. (17)
These Nestle products originated from Zurich, Switzerland, and were brought to Ramstein Air Base in Germany. They loaded on one C-17 cargo plane and flew to Indianapolis. This location was chosen because a Nestle distribution center is located just a mile away. (21)
The products were sent to the facility for standard quality control checks before distribution to pharmacies, hospitals, and doctor’s offices.
An administration official explained that the specialty formulas aren’t set to hit retail store shelves because they’re specialty products that are best sent to the medical facilities first. (21)
The specialty formulas are being prioritized because they’re needed by children with cow’s milk protein allergies who can’t just use regular formulas.
This first batch can feed 9,000 babies and 18,000 toddlers for just one week, explains Agriculture Secretary Tom Vilsack. But more are expected to arrive soon. (17)
More Formula Shipments Expected To Arrive Soon
The next formula shipment is for 114 pallets of Gerber Good Start Extensive HA formula, again through Operation Fly Formula. The second flight is expected to arrive in the coming days. (21)
Instead of heading for Indianapolis again, this next shipment is expected to land in Pennsylvania for distribution through the Nestle facility in the area. (21)
These first rounds of flights will carry a total amount of formula equivalent to 1.5 million doses (eight-ounce bottles), according to a White House representative. (17)
Danone (Aptamil) Increase Formula Shipments To The US
Danone SA, the makers of Aptamil based in Paris, France, announced that it has increased its formula shipments to help with the US shortage. (24)
It’s actually the world’s second-biggest infant milk formula maker, but Danone is just a small player in the US. However, from January to May 2022, Danone has more than tripled its imports through its Nutricia North America. As much as 90% of these formulas were delivered to the US. (24)
Customs data from ocean cargo shipments showed that the company shipped as much as 2.4+ million cans from January to May 2022 (excluding air cargo). That’s a stark increase from shipments of just around 770,000 cans in 2021 for the same period. (24)
House Passes Bills For $28 Million Emergency Spending & WIC Flexibility
The House recently passed two bills to address the shortage:
One bill grants the USDA (Department of Agriculture) secretary the permanent flexibility to issue waivers in supply disruptions so that WIC participants can buy any formula from available suppliers. This can give them more options than WIC-approved brands that could be unavailable due to a recall or shortage. (24)(25)
This move is significant because the government’s WIC program (Special Supplemental Nutrition Program for Women, Infants, and Children) caters to as much as 50% of infant formula sales in the US. (20)
The bill also requires all baby formula manufacturers to make a contingency plan to protect against supply disruptions during recalls or other significant events to prevent a similar shortage from happening again. (25)
The bill was passed in the House with a large bipartisan majority vote. It has also been approved by the Senate and is now up to Biden to sign into law. (26)
Emergency Spending Bill
Democrats proposed an emergency spending bill worth $28 million, which will boost the FDA’s resources. The measure covers additional staff for the agency. (20)
More staff means more people to work on tasks to help solve the shortage, explains Democrat Rep. Rosa DeLauro, the chair of the House Appropriations Committee. They will: (20)
- Inspect suppliers (both domestic and international)
- Prevent fraudulent products from being sold to unsuspecting consumers
- Acquire better data on the marketplace
Although this emergency bill was also passed, it was met with resistance from Republican representatives. Many of them believed that the FDA doesn’t need more staff. Instead, the money might be better spent on increased formula production. (20)
Rep. Andy Harris, the Appropriations subcommittee chair, blamed the problem on leadership issues, not on a money or budget problem. (25)
Republican Conference Chair Elise Stefanik also blamed the crisis on Biden’s “failed leadership.” (26)
As many as 192 Republican lawmakers voted against the measure. They said, “Throwing millions of dollars at this problem won’t fix it.” Instead, they filed a counter bill, “Babies Need More Formula Now Act”. It aims to obtain formulas from overseas sources. (26)
Aside from getting resistance in Congress, the bill is also expected to encounter strong opposition in Senate after Republican senators questioned why the FDA wasn’t held accountable for the possible lapses that led to the infant deaths linked to Abbott’s formulas. (27)
Congress Investigates The FDA
In a bipartisan hearing, FDA Commissioner Dr. Robert Califf faced Congress as they investigated the baby formula shortage.
He was asked by Rep. Rosa DeLauro and other lawmakers why the agency didn’t act on the whistleblower complaint on possible safety violations at Abbott’s Sturgis plant. (28)
Califf reportedly sidestepped the lawmakers’ questions by replying that he couldn’t share details of the FDA’s ongoing investigation. (28)
Although he admitted to reading the complaint, he didn’t specify when or what steps he or the other officials took to immediately address the issue.
Instead, the FDA commissioner announced that Abbott could restart production in a week or two. However, the plant’s reopening will be subject to safety upgrades and certifications. (28)
Agency Asks For More Budget
The FDA asked lawmakers for a budget increase from last year’s $2.1 billion to $8.4 billion so they can use it to improve food safety and nutrition. (27)
It will include a $76 million increase to be used for the following: (27)
- Food safety funding that can help improve technology to trace the source of foodborne illnesses quickly
- Other efforts to reduce toxins found in food
Califf told lawmakers that the FDA needs these major improvements, not because of bad people but because the agency needs the right resources and consistent leadership. (28)
Limited Competition Made Formula Market Vulnerable
Before the recall and formula shortage, 90% of the US formula market is dominated by just four players: (28)
- Abbott (Similac)
- Perrigo (Parent’s Choice)
- Reckitt Benckiser (Enfamil)
Not surprisingly, these four companies also dominate the federal contracts for the WIC program intended for low-income families. It accounts for 50% of US formula productions. (28)
So, when there are major disruptions to these companies’ supplies, including a massive recall, you can expect the formula supply in the market to be affected.
The massive Similac recall disrupted the market supply.
Before February 2022, Abbott Nutrition topped the market spot with 40% of the share. It was followed closely by the long-time number 2 baby formula brand in the US, Enfamil. However, Reckitt Benckiser recently claimed that Enfamil now has the top spot or around 50% of the market share. (24)
After the Similac recall, Enfamil now feeds around 211,000 more babies than it had before the formula shortage began. (29)
The company added that Enfamil production had been increased to 30% to meet the market demands. (24)
However, Enfamil’s increased production still couldn’t fill in all the formulas the market needs as the shortage continues to worsen.
Groups: Food Safety Should Be A Priority
Groups are calling on the FDA and other government agencies to prioritize food safety in order to avoid a repeat of the current formula crisis.
Many of them are also calling for the FDA to be held accountable for their possible lapses, which could have led to the Abbott plant closure and subsequent baby formula shortage. (30)
Because the deputy food commissioner position was removed during the Trump administration, the groups are also encouraging the FDA to restore this position so that there will only be one leader focused on unifying and improving the agency’s food program. (30)
Consent Decree For Abbott To Comply With
Abbott needs to comply with a legally binding consent decree signed off by a federal judge between the company and the FDA. This decree details the steps they must comply with before their formula production can resume. (31)
It was filed at the US District Court for the Western District of Michigan, with Abbott needing to follow these steps: (31)(32)
- Cleaning and sanitizing their facility and various equipment
- Restarting the equipment
- Doing test runs on all equipment
- Conducting multiple tests on processes
- Checking all raw ingredients and materials
- Hiring an independent third party expert in charge of reviewing its processes
The consent decree also requires Abbott to immediately stop production and notify the FDA of any kind of contamination experienced at the plant. It’s a stipulation added so that the possible contamination and massive recall won’t happen again. (32)
The company is also tasked to change these: (31)
- Environmental monitoring program
- Testing plans
- Product sampling
- Employee training programs
CEO: “Serious Steps” Taken To Address Formula Shortage
Many people have blamed the formula shortage on Abbott because of the massive recall of its products, including Similac Elecare, and Alimentum products in February 2022. Acknowledging this, Abbott Laboratories CEO Robert Ford apologized to the public and detailed the “serious steps” the company is taking to help solve the problem. (33)
These “serious steps” include the following: (33)
- Creating a $5 million fund, especially for families whose children were hospitalized because they didn’t have access to specialized Abbott products
- Converting the production lines at their Columbus, Ohio, facility from adult nutrition products to ready-to-feed liquid infant formula
- Acceleration of production processes
- “Rigorous inspections” of all finished products
- Air-shipping millions of Abbott’s widely used formulas from an FDA-approved facility in Ireland to restock store shelves
Ford also assured the public that once production started, the company will do the following: (33)
- Increase production by more than double
- Make significant facility investments to ensure the previous problems don’t happen again
- Upgrade safety and quality processes, including equipment
Considering that Abbott had a 40% share (before the recall) of the infant formula market in the US, reduced production rates and a plant shutdown can affect the formula supply. The recall worsened the formula shortage that was already affecting the US since 2021. (34)
Abbott CEO: We Did The Right Thing
According to Abbott’s CEO, they did the right thing in issuing the voluntary recall.
He explained that the bacteria found at their plant didn’t match those found in the affected babies’ samples, but they issued the voluntary recall to reduce the risks to children’s lives and health. (33)
The FDA Refutes Abbott’s Claim
Although Abbott maintains that the bacterial strains from their plant didn’t match those from the FDA’s investigations, FDA officials recently refuted this claim. (20)
According to FDA food director Susan Mayne, the agency was only able to take samples from two cases instead of four. They were unable to determine whether Abbott products were linked to these babies’ cases because of the insufficient DNA sequences from the other two babies. (20)
Still, despite this inconclusive evidence, the affected plant can reopen soon.
FDA officials explained that even if the Abbott plant in Sturgis will reopen, the company needs to comply with various requirements: (20)
- Must retrain staff
- Should exhaustively clean the entire facility and all equipment
- Repeatedly test and provide documentation that there isn’t any contamination left in any part of the facility
Under its new import policy, the FDA will also require baby formula companies to provide documentation of factory inspections to ensure their products meet the highest safety standards. (20)
Groups: Abbott Enriched Shareholders Despite Plant Needing Repairs
Several groups are calling out Abbott for reportedly enjoying high profits (as high as 94%) between 2019 and 2021, even if bacteria were already detected in its products within the same period. (35)
Abbott’s net profits reportedly increased from $3.6 billion to $7.1 billion, two years before the recall, according to records of the Securities and Exchange Commission. (35)
When news of the recall hit, the company allegedly increased dividends to shareholders by over 25%. They also offered shareholders a stock buyback program that’s worth $5 billion. (35)
This information alarmed progressive economic advocacy group, Groundwork Collaborative. According to its group’s chief economist, Rakeen Mabud, Abbott chose to prioritize its shareholders instead of consumers. They put their money to help the shareholders instead of improving the plant or making productive investments. (35)
After learning about this, the Senate Finance Committee announced that they’re going to investigate Abbott’s investments and the reported stock buyback program. (27)(35)
Moe Tkacik, a senior fellow of the American Economic Liberties Project, said that buybacks were illegal until 1982 and they were considered a form of manipulation. (35)
The group pushes for a ban on buybacks, putting limits on shareholder dividends, and stricter antitrust enforcement.
Tkacik also accused companies like Abbott of using products as a personal ATM. She added that there should be restrictions imposed on companies receiving federal funding or having federal programs as their largest customers, such as the WIC in Abbott’s case. (35)
An Abbott spokesperson explained that their “strong balance sheet” let them invest in improving their facilities even if they offered the stock buybacks. So, the program didn’t hurt the products’ safety, the spokesperson added. (35)
Pelosi: Criminal Charges Possible Over Baby Formula Shortage
House Speaker Nancy Pelosi calls the shortage “unconscionable and tragic,” describing how there are so many babies left hungry and crying. She wants those responsible to pay for what they did, saying that there might be a need for indictment. (36)
However, she explained that the indictment can wait until the nationwide baby formula shortage is resolved.
Although Pelosi didn’t specify the details of the possible criminal charges, she clarified that her remarks aren’t associated with her colleagues. (36)
States Hardest Hit By The Formula Shortage
While the nationwide out-of-stock rate was around 40% in April 2022, it soared to 50% in the following states: (37)
- South Dakota
- North Dakota
Sometime in May, Nevada announced that it’s also experiencing a decrease of at least 50% of the state’s baby formula supply. (38)
Scammers Take Advantage Of Formula Shortage
The FTC (Federal Trade Commission) warns desperate parents against paying hefty prices for formulas through fraudulent online stores, explaining that scammers are taking advantage of the situation. (39)
Some of these scammers create fake social media accounts or websites mimicking recognizable formula brands but selling highly marked-up products. (39)
Many unsuspecting customers pay for the products from legitimate-looking “official” sites, but their order never arrives.
Tips To Avoid Scammers
The FTC recommends doing the following to avoid getting scammed: (39)
- Use a search engine to check a company, brand, or product using terms like “scam,” “review,” or “complaint.”
- Don’t pay using money transfer, gift cards, or cryptocurrency. Credit card payments might offer the most protection because you can process a refund if your order doesn’t arrive.
- Research about the company and know your rights, especially regarding shipments and refunds.
- Check for local resources. Your pediatrician or local WIC office might have available stocks.
Can The US Import Baby Formula From Other Countries?
This can be tricky because the FDA has specific nutritional standards that differ from those followed by other places, including Canada and the European Union. (40)
Also, the US levies heavy tariffs on imported infant formula as high as 17.5%. (40)
FDA Commissioner Robert Califf announced on May 16, 2022, that their “loosening” restrictions on imported infant formula to “efficiently and safely” improve the local supply. (40)
However, the FDA’s published guidance still requires formula manufacturers to meet the minimum requirements for specific nutrients, labeling, and product safety tests. (41)
FDA Reportedly Continues To Seize European Baby Formula Amid Shortage
The FDA announced that it would streamline regulatory approvals for European formulas to make it easier for popular brands such as Hipp, Holle, and Kendamil to get permission to sell in the US. (42)
However, since these formulas are still unregistered, the FDA reportedly continues to crack down on sellers offering these products. (42)
Some American parents who ordered European formulas directly from Europe had their orders seized and destroyed by US customs agents. (42)
The FDA explained that these European formulas: (42)
- Don’t meet FDA labeling requirements (such as formula-preparation instructions in English, specific labeling on iron content, or instructions on how to store the product)
- Require less water per scoop than US formulas
- Might need different temperature conditions for storage
- Don’t have a system to notify US consumers of recalls
Still, even if major European producers like Hipp and Holle didn’t comply with FDA regulations, they’re regulated by European regulatory authorities. (42)
Studies show that most meet FDA-required nutrient levels. However, some don’t contain iron levels that meet the FDA’s minimum requirements.
These European formulas can help ease the formula shortage for many desperate parents. They hope that the FDA can instead find another approach instead of destroying precious formulas.
As the FDA continues to crack down against European formulas, many American parents are hoping that the federal agency will help make these options safer by: (42)
- Coordinating with European regulatory authorities on recalls
- Providing English-language instructions (already offered by some European formula importers)
- Explaining European health and safety standards
- Converting to American-size scoops
AAP Lowers Age Recommendation For Cow’s Milk
Amid the formula shortage, a recent AAP (American Academy of Pediatrics) FAQ showed a much lower age recommendation for cow’s milk from one year old to six months of age. (43)
A Pediatrician’s Recommendation
The division chief for Pediatrics at Spectrum Health, Dr. Hanna Jaworski, explained that cow’s milk could be a better option than watered-down formula. However, it has its risks, including an increased likelihood of anemia. (44)
Jaworski recommends choosing cow’s milk over homemade formula or diluted formula but added that this should only be as a “bridge” for a day or two until you can find your preferred formula. (44)
She also recommends keeping the cow’s milk at 24 oz or less and providing your baby with their formula or a close alternative as soon as possible. (44)
She warns that cow’s milk should never be considered even as a temporary substitute for babies with special health needs or those using specialty formulas for allergies.
A Pediatrician’s Warning
However, Bronson Methodist Hospital pediatrician Dr. Megan Sikkema warns parents against following the AAP’s new recommendation. She said that it should only be done as a last resort. (44)
She added that if you can’t help but give your baby cow’s milk, make sure it’s really for as short as possible. Once you find some formula, switch back immediately.
Harmful DIY Baby Formula Recipes Go Viral
Harmful DIY baby formula recipes go viral as desperate parents search for alternatives amid the shortage. (45)
But the FDA advises parents against making homemade baby formula because it could lack vital nutrients needed to support their baby’s growth. One baby has already been hospitalized due to mineral imbalances from taking homemade formula. (17)
Social media platforms are scrambling to remove or label these baby formula recipes. However, according to a Bloomberg report, many aren’t doing it consistently. (45)(46)
According to the report, Twitter posts about homemade baby formula rose as much as 2,100% (around 5,000 tweets) from the first to the second week of May. (45)
Bloomberg was able to get several YouTube and TikTok videos or posts removed. Aside from the videos raised by Bloomberg, YouTube also removed content that sells, promotes, or provides instruction for making homemade baby formula under their Harmful & Dangerous policies. (45)
However, Twitter didn’t consider the posts a breach of their misinformation policy but told the outlet they’ll review their practices “over time.” (45)
Meta, Facebook’s parent company, told the outlet that they’re using external content reviewers to add warning labels on baby formula misinformation posts. (45)
Viral Post Mistakenly Blames US Formula Shortage on Ukraine Relief Shipments
A Mississippi-based nonprofit organization is being bashed on social media after mistakenly getting blamed for the US formula shortage due to their Ukraine relief shipments. (47)
Kathy Cadden founded Operation Ukraine some 22 years ago after learning of the sad plight of orphanages in the war-torn country years after the Soviet Union breakup.
Since the Ukraine war began, the organization has sent baby formula to provide 60,000 four-ounce servings but has since suspended collecting formula donations amid the US shortage. (47)
The shipments are but a small fraction of the US formula production. Still, a viral post showing screen grabs of news reports about the Ukraine relief and the formula shortage made people hate Cadden and her group.
Even though Cadden explained that she didn’t create the problem, she has received threats from people who said she’s “killing American babies” and “working for Satan.” (47)
Biden Administration’s Measures For Addressing Formula Shortage
Update: May 16, 2022
US President Joe Biden met with retailers and baby formula manufacturers, particularly Gerber, Reckitt, Walmart, and Target, to discuss measures to help address the shortage while ensuring that formulas reach store stores safely. (22)
The White House released these measures that the Biden administration plans to follow for an increase in the number of formula products in the market, but without compromising babies’ safety: (22)
Cracking Down On Illegal Sellers For Unfair Market Practices & Price Gouging
Amid the formula shortage, some unscrupulous retailers or individuals bought dozens of formulas from legitimate suppliers but marked them up to several times the actual price for online retail to desperate parents. (22)
Some formulas normally sold for $43 to $47 are offered on eBay and other online sites for as high as $800. (48)
To avoid hoarding, retailers like CVS, Walmart, and Target have put a cap on the quantity that consumers can buy. However, they’re still running out of baby formulas despite these measures. (48)
President Biden asked the FTC (Federal Trade Commission) to crack down on these illegal sellers and use all its available tools for identifying, investigating, and monitoring these people for predatory conduct, unfair market practices, and price gouging. (22)
Increasing Supply Through Imports
The US typically produces around 98% or nearly all of the baby formulas it needs. However, the baby formula shortage started in 2021 due to supply chain issues and was worsened by the recent Similac recalls. (22)
To help keep up with the lower supplies and higher demands, the White House announced plans to increase imports from key suppliers, including the Netherlands, Chile, Mexico, and Ireland. (22)
Cutting The Red Tape
According to the White House, as many as 50% of the formula manufacturers’ production goes to the WIC program (Special Supplemental Nutrition Program for Women, Infants, and Children). (22)
To meet varying demands, particularly WIC conditions, manufacturers produce different formula sizes even with the same type.
The White House believes that if manufacturers focus on simplifying product offerings, then they might increase production.
Aside from this measure, the USDA (United States Department of Agriculture) is coordinating with different states to let WIC recipients buy available products (instead of only buying WIC-approved options). (22)
Abbott Plans To Reopen Sturgis Plant Involved In Recall
The formula out-of-stock rates have soared to 43% in the first week of May, and the FDA said that it’s working with manufacturers to increase the supplies. (49)
On May 12, 2022, the CDC (Centers for Disease Control and Prevention) closed its investigation of the Abbott Nutrition products linked to the Cronobacter infections after no additional cases have been identified. (50)
However, the recall is still in effect. It’s only the investigation that’s closed.
The FDA has also established an IMG (Incident Management Group) to help address the food safety and supply chain issues that are worsening the formula shortage. (50)
It is believed that Abbott Nutrition’s reopening of its Sturgis, Michigan plant, the one involved in the massive Similac recall in February 2022, might boost the stocks.
Abbott Nutrition announced that production could restart in about two weeks (or by the end of May), subject to FDA approval. (51)
However, Abbott Nutrition estimates that it could take six to eight weeks before these formula products hit the shelves from the Sturgis plant’s reopening.
To assure worried customers, Abbott Nutrition explained that they had improved their systems and protocols at the Sturgis facility.
These improvements include the following: (51)
- Updating their training, education, and safety procedures applicable for employees and visitors
- Updating protocols for cleaning, water, and maintenance procedures
- Upgrading the plant, including installation of sanitary, easily cleanable, and nonporous floors
Nutricia Tests Positive For Cronobacter In Australia
Nutricia KetoCal 3:1 tested positive for Cronobacter (a type of bacteria also involved in the massive Similac recall in February 2022) during routine screening by Australian customs. However, the company hasn’t issued a recall of its products. (52)
The contaminated product only affects Nutricia KetoCal 3:1 with batch number 101101598 and best before date of “8 July 2023.” (52)
The Cronobacter contamination was discovered during a routine check as part of Australian Customs’ normal procedure to randomly test imported products occasionally.
How Will You Know If Your Ketocal 3:1 Is Included?
Check the bottom of the Nutricia Ketocal 3:1 can for the following: (52)
- Batch number of 101101598
- Expiry date of 08.07.2023
What To Do If You Purchased This Product
Nutricia doesn’t recommend stopping formula use without medical consultation. (52)
You can immediately consult your child’s specialist pediatrician, metabolic physician, neurologist, or dietitian before you stop using the formula.
In a factsheet made by Nutricia, parents and carers are advised to continue using this product for their babies using revised preparation instructions. (52)
Abbott Nutrition Releases Some On-hold Products Amid Formula Shortage
Update: May 4, 2022
Abbott Nutrition announced that they’re fulfilling the FDA’s request to release some metabolic nutrition and specialty formulas put on hold in February following the Similac recall. (53)
The products to be released won’t include Similac, Alimentum, and EleCare powder formulas. (53)
However, although Similac PM 60/40 was part of the February recall, it will be released again. Abbott Nutrition explained that only one lot of this product was recalled in February.
Abbott assures customers that all these products have been tested. The items comply with all the release requirements before product distribution. (53)
The company also clarified that these products are available in limited quantities because production hasn’t resumed yet at the Sturgis facility. These products to be released were those put on hold amid the recall.
As of press time, Abbott is still working with the FDA on the corrective actions needed at the facility before they can resume production. (53)
Once production starts again, however, it could take at least 6-8 weeks before these baby formula products will be available for distribution.
Aside from Similac PM 60/40, these metabolic products will also be released: (53)
- Calcilo XD
- Cyclinex-1 and 2
- Glutarex-1 and 2
- Hominex-1 and 2
- I-Valex-1 and 2
- Ketonex-1 and 2
- Phenex-1 and 2
- Propimex-1 and 2
- Tyrex-1 and 2
These metabolic nutrition formulas will be released for free to patients but in coordination with healthcare professionals on a case-by-case basis. (53)
Whistleblower Told The FDA About Abbott’s Security Lapses Months Before Recall
Update: April 29, 2022
The office of House Appropriations Committee Chair Rep. Rosa DeLauro received a 34-page report from a whistleblower who used to work at the Abbott Nutrition facility that produced the recalled Similac formulas in February 2022. (54)
The whistleblower made a long list of allegations regarding security lapses and unsafe practices at the plant in Sturgis, Michigan.
The whistleblower alleged that Abbott Nutrition: (54)(55)
- Hid information during a 2019 FDA audit (he claims the managers may have “sanitized” files)
- Falsified records about several safety and quality concerns: signing verifications without adequate knowledge, shipping products with actual weights lower than the label, “tampering” with maintenance records (such as time code removal), etc.
- Lack of traceability of their products
- Released untested infant formula (after discarding contaminated samples)
- Lax practices in terms of keeping the place clean
- Failed to take any corrective measures after learning that their testing procedures were deficient
- An atmosphere of retaliation against employees raising concerns about unsafe company practices
The whistleblower also claims that he sent this report to the FDA in October 2021, months before the babies’ deaths and the February 2022 Similac recall. (54)
Rep. DeLauro was alarmed that the FDA didn’t act quickly to check on the whistleblower’s report, especially because it involves possible unsafe production of infant formula if proven true. (56)
However, Abbott Nutrition denies the whistleblower’s allegations, saying the guy had actually been dismissed over serious violations of the company’s food safety policies. (57)
They added that the former employee made a false report and submitted it to multiple authorities after his dismissal.
Abbott maintains that they: (57)
- Take employee concerns very seriously
- Foster a culture of compliance to ensure they produce the highest quality baby formulas
- Empower workers to identify and report issues that could compromise their products’ safety and quality
Also, the company insists that its products aren’t the source of the infections based on internal investigations. (57)
FDA Finds Safety Issues At Abbott Plant Involved In Formula Recalls
(Update: March 22, 2022)
Federal safety inspectors released their findings after conducting an investigation at Abbott’s manufacturing plant in Sturgis, Michigan. It’s the one involved in the recent Similac recall over several safety issues. (58)(59)
The FDA’s preliminary findings include the following safety concerns: (58)(59)
- Failure to establish a process control system covering all the processing stages to ensure that the products don’t become contaminated due to the presence of Cronobacter bacteria and other microorganisms in the formula ingredients or its processing environment (60)
- Failure to maintain the sanitary conditions and cleanliness of surfaces that come in contact with the baby formula products
- Plant history of eight instances of contamination (with Cronobacter bacteria) from fall 2019 to February 2022
After the massive formula recall was announced, the Senate health committee asked the company to detail how much time passed from the first reported case to the day they issued the recall. (58)(59)
Abbott received the first health report from Minnesota health officials last September, and the FDA conducted safety inspections then. The company also received health reports from Ohio and Texas in the following months.
What’s alarming, however, is that despite noticing several safety issues at the time, the FDA didn’t stop Abbott from producing the formulas until the issues have been resolved.
The federal agency also failed to issue a safety notice or recall of these products, which might have stopped the contamination that led to at least two reported infant deaths and eight hospitalizations.
In its Abbott plant inspection last September 2021, federal inspectors found the following safety violations: (58)(59)(60)
- Unsanitary conditions (including leaking pipes, water on the floor, and dirt or other health hazards in some production areas)
- Absence of temperature controls
- Some employees failed to properly sanitize their hands upon entering the production area
It’s unclear why the FDA hadn’t issued a safety recall earlier, considering the safety issues could lead to infant formula contamination.
Recent findings in inspections conducted from January 31 to March 18, 2022, showed that the same safety concerns as the September 2021 report were observed inside the factory. (61)
In addition, they found more unsanitary conditions: (61)
- Debris (such as duct tape) and dirt in the floors of the production area
- Several workers failed to properly sanitize their shoes upon entering the production area
- At least four sites tested positive for Cronobacter sakazakii bacteria
Food safety advocates are furious over how the FDA and Abbott addressed these safety issues. Because of their lapses, the possibly contaminated formula produced in the factory may have caused the death of the two babies.
Sarah Sorscher of the Center for Science in the Public Interest said: (58)(59)
“This sheds a little more light on what went wrong, but we still don’t have all the answers. Abbott and the FDA really need to do more work to get to the bottom of what happened so we can prevent the next outbreak.”
There might be a need to evaluate how formulas are made. Experts point out that this product isn’t subjected to the same high temperatures other foods undergo to kill potentially deadly bacteria and other germs.
Considering the deaths and hospitalizations of several infants linked to the possible contamination, something must be done to correct this serious safety concern.
They want answers, and for the FDA and Abbott to find the root cause of the problem to ensure that infant formula contaminations won’t happen again.
In response, Abbott assures the public that they’re “taking this very seriously and working closely with the FDA to implement corrective actions.” (58)(59)
You can read more about these formula recalls below.
Similac Recall 2022 (First Recall)
In February 2022, Similac recalled several powdered formulas for possible contamination with bacteria, specifically Cronobacter sakazakii and Salmonella.
The company issued the recall following reports of four hospitalized babies from bacterial infection, and one possible infant death due to Cronobacter after allegedly drinking Similac formulas. (1)(62)
- Date Recalled: February 17, 2022
- Company Name: Abbott Nutrition
- Reasons For Recall: Possible contamination with Cronobacter sakazakii and Salmonella bacteria (62)
- Affected Products: Similac, Alimentum, and EleCare powdered infant formulas
- Return or Refund Processing: 1-800-986-8540
The recall advisory advises parents to check the packaging of their powdered formulas for the following codes included in this recall: (62)
- Similac, Alimentum, and EleCare powdered infant formulas
- The code contains K8, SH, or Z2
- The first two digits of the codes are numbers from 22 to 37
- The expiration date code is from 4-1-2022 (APR 2022) or later
The recall was issued after four infants from three different states (MN, OH, and TX) fell ill and were hospitalized after reportedly consuming the Similac powdered infant formula mentioned above. These were produced in Abbott Nutrition’s Sturgis, Michigan facility.
All four cases were hospitalized, with one possible death due to Cronobacter. However, the authorities are still investigating to confirm whether the formula might have contributed to the death of one of these babies. (62)
The FDA recall advisory announced some positive results from test samples at the facility:
“Findings to date include several positive Cronobacter sakazakii results from environmental samples taken by the FDA and adverse inspectional observations by the FDA investigators.
A review of the firm’s internal records also indicate environmental contamination with Cronobacter sakazakii and the firm’s destruction of product due to the presence of Cronobacter.” (62)
The FDA explains that Cronobacter can cause severe, life-threatening infections. These can include sepsis (blood infection) or meningitis (inflammation of the membranes protecting the brain and spine). (62)
It can also cause bowel damage and spread through the blood to other parts of the body.
Cronobacter infections can be deadly, especially to newborn babies.
Symptoms of meningitis and sepsis can include the following: (62)
- Temperature changes
- Grunting breaths
- Unusual movements
- Poor feeding or no appetite
- Jaundice (yellow skin and whites of the eyes)
The products from Abbott Nutrition’s Sturgis, Michigan facility have been distributed across the US and are likely to have been exported to other countries, the recall advisory warned.
Parents are told to stop using and discard any product included in this recall, even if it looks alright.
Call Abbott for refund processing or product replacement.
Abbott clarifies that all products undergo rigorous testing, including routine tests for Cronobacter sakazakii and other pathogens in their manufacturing facilities before these are released for public consumption.
They further explained that their routine tests found evidence of Cronobacter sakazakii in the plant’s non-product contact areas, but there wasn’t evidence of Salmonella Newport. However, they’re also investigating this matter.
More importantly, retained samples of products relating to the complaints tested negative for the pathogens.
Here’s Abbott’s statement regarding this massive recall:
“Importantly, no distributed product has tested positive for the presence of either of these bacteria, and we continue to test. Abbott conducts extensive quality checks on each completed batch of infant formula, including microbiological analysis prior to release.
All finished products are tested for Cronobacter sakazakii, Salmonella Newport and other pathogens and they must test negative before any product is released.
Additionally, retained samples related to the three complaints for Cronobacter sakazakii tested negative for Cronobacter sakazakii. And the retained sample related to the complaint for Salmonella Newport tested negative for Salmonella Newport.” (1)
This recall doesn’t include Abbott liquid formulas, any metabolic deficiency nutrition formulas, or other nutrition products made and sold by the company.
Abbott explains that Cronobacter sakazakii can be commonly found in the environment, including areas around the home. (1)
They remind parents and caregivers to follow the instructions on the packaging for proper handling, preparation, and storage of all powder formulas to avoid any contamination.
Similac Recall 2022 (Second Recall)
- Date Recalled: February 28, 2022
- Company Name: Abbott Nutrition
- Reasons For Recall: Possible contamination with Cronobacter sakazakii bacteria (1)
- Affected Products: Similac PM 60/40
- Return or Refund Processing: 1-800-986-8540
Abbott voluntarily recalled another Similac product to the on-going recall: a lot of Similac PM 60/40 with lot # 27032K80 (can) or lot # 27032K800 (case). It’s also manufactured in the company’s facility in Sturgis, Michigan.
It was done following the death of another infant who tested positive for Cronobacter sakazakii. The baby had consumed Similac PM 60/40 from this lot.
The case is still under investigation, with authorities trying to determine the cause of the infant’s Cronobacter sakazakii infection.
Abbott clarifies that distributed products in the recent recalls (Similac PM 60/40 and the previously recalled Similac, Alimentum, and EleCare powdered infant formulas) all tested negative for the presence of Cronobacter sakazakii. (1)
Angel Formula Recall (2022)
- Date Recalled: January 7, 2022
- Company Name: Moor Herbs
- Reasons For Recall: Failure to meet FDA requirements (63)
- Affected Products: “Healthy Beauty” Angel Formula
- Return or Refund Processing: 313-583-9709
The FDA announced that “Healthy Beauty” Angel Formula failed to meet their criteria:
- It contained much higher iron, potassium, and sodium content than the maximum limits. However, the FDA recall advisory didn’t indicate the values of their test results. (63)
- The product also failed to meet the FDA’s labeling requirements because it doesn’t show a UPC (Universal Product Code) and a manufacturing lot code.
- The FDA also clarified that it hasn’t received pre-market notifications from the company. (63)
What Formula Is Recalled In 2021?
Able Groupe Baby Formula Recall
- In August 2021, Able Groupe recalled several products from HiPP, Holle, Kendamil, and Bioland (Lebenswert) imported from Europe and sold by the Little Bundle website. (64)
- These formulas were recalled for failure to meet FDA requirements (U.S. Food and Drug Administration) for pre-market notifications. (64)
- Many also failed to meet the minimum iron levels or provide proper labeling to warn parents about the possible need for iron supplements. (64)
- According to the FDA’s recall advisory, regularly feeding your child with a formula with low iron levels (below 1 mg iron per 100 calories) can lead to iron deficiency anemia. This condition may cause irreversible cognitive and/or functional development outcomes. (64)
- You can contact [email protected] for questions or refund processing. (64)
The following products (all lot codes) were included in the recall: (64)
- Holle Bio Organic Infant Milk Formula (Stage PRE; 0-6 months)
- Holle Bio Organic Infant Milk Formula (Stage 1; 0-6 months)
- Holle Bio Organic Follow-on Milk Formula (Stage 2; 6+ months)
- Holle Goat Organic Infant Milk Formula (Stage 1; 0-6 months)
- Holle Goat Organic Follow-On Infant Milk Formula (Stage 2; 6+ months)
- Holle Goat Organic Toddler Formula (Stage 3; 10+ months)
- HiPP Anti-Reflux Milk Formula (from birth)
- HiPP Comfort Milk Formula (from birth)
- HiPP Dutch Combiotic Infant Milk Formula (Stage 1; 0-6 months)
- HiPP Dutch Combiotic Follow-on Milk Formula (Stage 2; 6+ months)
- HiPP HA Germany Hypoallergenic Stage PRE Combiotic Infant Milk Formula (0-6 months)
- HiPP HA Germany Hypoallergenic Combiotic Infant Milk Formula (Stage 1; 6+ months)
- HiPP HA Germany Hypoallergenic Combiotic Follow-on Milk Formula (Stage 2; 6+ months)
- HiPP German Combiotic Infant Milk Formula (Stage 1; 0-6 months)
- HiPP German Combiotic Follow-on Infant Milk Formula (Stage 2; 6+ months)
- HiPP UK Combiotic First Infant Milk Formula (Stage 1; 0-6 months)
- HiPP UK Combiotic Follow-on Infant Milk Formula (Stage 2; 6+ months)
- Lebenswert Anfangsmilch Organic Infant Milk Formula (Stage 1; 0-6 months)
- Lebenswert Anfangsmilch Organic Follow-on Milk Formula (Stage 2; 6+ months)
- Kendamil Organic First Infant Milk Formula (Stage 1, from birth)
- Kendamil Organic Follow on Milk Formula (Stage 2; 6+ months)
Although these products have been recalled, they may still be safe for your baby.
But due to the lower iron content, make sure to consult with your pediatrician. Your child might need iron supplementation to meet their nutritional needs while using these formulas.
Also, not all of these products have low iron content. But they were still recalled by the FDA for lack of pre-market notifications. (64)
These recalled European formulas have iron content that meets the FDA standards: (64)
- HiPP Anti-Reflux Milk Formula (from birth): 1.06 mg
- HiPP Dutch Combiotic Follow-on Milk Formula, Stage 2 (6+ months): 1.47 mg
- HiPP HA Germany Hypoallergenic Combiotic Infant Milk Formula, Stage 1 (6+ months): 1.01 mg
- HiPP HA Germany Hypoallergenic Combiotic Follow-on Milk Formula, Stage 2 (6+ months): 1.43 mg
- HiPP German Combiotic Follow-on Infant Milk Formula, Stage 2 (6+ months): 1.47 mg
- Holle Bio Organic Follow-on Milk Formula, Stage 2 (6+ months): 1.18 mg
- Holle Goat Organic Follow-On Infant Milk Formula, Stage 2 (6+ months): 1.47 mg
- Holle Goat Stage 3 Organic Toddler Formula, 10+ months: 1.52 mg
- Lebenswert Anfangsmilch Organic Follow-on Milk Formula, Stage 2 (6+ months): 1.43 mg
- HiPP UK Combiotic Follow-on Infant Milk Formula, Stage 2 (6+ months): 1.47 mg
- Kendamil Organic First Infant Milk Formula, Stage 1 (from birth): 1.10 mg
- Kendamil Organic Follow on Milk Formula, Stage 2 (6+ months): 1.06 mg
But be sure to always seek your pediatrician’s advice before starting or switching formulas, especially if they’ve been recalled.
Designed by Nature Recall
- In June 2021, Designed by Nature baby formula products (base formula, cow milk, and goat milk) were recalled for possible health and safety risks due to incorrect labels. (65)
- According to the FDA, these products aren’t intended for use as infant formula, but the brand didn’t indicate that on the packaging. (65)
- The company also reportedly admitted to the FDA that they aren’t testing for the presence of Cronobacter, a potentially dangerous and deadly bacteria, especially for babies. (65)
SMA Wysoy Infant Formula (UK) Recall
- In March 2021, Nestle UK recalled SMA Wysoy Infant Formula (28.22 oz) for possible contamination with blue plastic pieces. (66)
- These contaminants can make the formula unsafe and may also be a potential choking hazard to your baby. (66)
The following are the affected batch codes with their corresponding “best before date” codes: (66)
- 923357651Z, 20 August 2021
- 025057652Z, 15 October 2021
- 000957651Z, 8 January 2022
- 015757651Z, 5 June 2022
- 024957651Z, 5 September 2022
- 025057652Z, 6 September 2022
- 025057651Z, 6 September 2022
- 025157651Z, 7 September 2022
Formula Recall 2019
Kirkland Signature Brand by Costco, Non-GMO Formula For Babies Sensitive To Lactose (Canada) Recall
- In October 2019, Costco Wholesale Canada Ltd. recalled this formula for possible Cronobacter spp. contamination. (67)
The recall affected the following lot codes: (67)
- (1.36 kg) EXP 2020 NO 05 T05DVBV
- (2-pack, 2 x 1.36 kg) EXP 2020 NO 05 T05DVBV
Calcilo XD Formula Recall
- In September 2019, Abbott Laboratories recalled Calcilo XD powder cans (13.2oz) over inconsistencies in the aroma or color. (68)
- Only the batch with lot number 79696K80 was affected. (68)
Is Similac Formula Being Recalled?
Similac TummiCare One Infant Formula (Philippines) Recall
- In August 2019, Abbott Laboratories recalled this formula in the Philippines due to differences in the label instructions and preparation scoop size. (69)
- The product is safe to consume. But the incorrect preparation using the scoop (provided in the box) might not provide your baby with enough nutrients to support normal growth. (69)
- It only affected batch no. 03518QU (manufacturing date March 2019; and expiration date March 2022) (69)
Parent’s Choice Advantage Infant Formula Recall
- In June 2019, Perrigo Company plc recalled this formula (35 oz containers) for possible contamination with a metal foreign matter. (70)
- Only one batch (lot code C26EVFV with a “use by” date of February 26, 2021) was affected. (70)
Enfamil Powder Formula Tampering (2019)
In June 2019, Ashley Frydrych bought two containers of an Enfamil baby formula in Tampa Bay, Florida. (71)(72)
She noticed that one of the containers had weird contents. It didn’t look or smell like the formula she regularly bought for her baby. (71)(72)
At first, she thought that the name brand had changed the formulation. So, they used it for preparing their baby’s bottle that night. But the child refused to drink it. (71)
Still not realizing that something was wrong with the formula, Frydrych thought that her son was just full or having a stomachache. (71)
She prepared a new batch of formula the following morning, but her husband noticed that the contents immediately separated when they prepared a fresh bottle. The powdered contents settled while the water was on top. (71)(72)
Upon checking the tub, they were surprised to discover that the contents looked and smelled more like flour than baby formula. (71)
Frydrych’s husband tasted it and confirmed that it was flour. (71)(72)
She immediately reported the matter to Publix, where she purchased the formula. They quickly took action and checked the remaining tubs for any signs of tampering. (71)
Frydrych called out Enfamil to change their packaging to avoid similar incidents in the future. (71)
In response, Enfamil assured customers that they’re confident about the safety of their products because of their long history of quality. (71)
After conducting separate investigations, Enfamil and Publix assured customers that it was an isolated incident. They didn’t issue any recall on the formula. (71)(72)
Formula Recall 2018
Bebe Mandorle Stage 2 (Bio) Recall
- In November 2018, La Mandorle recalled this product for possible contamination with Cronobacter sakazakii, a deadly bacteria. (73)
- The recall only included batch number 100762029 (expiry date 13-10-2019). (73)
Milupa Aptamil 1 Pronutra (Store Recall In Slovenia)
- In August 2018, retailer Mueller Drogerija recalled this Danone formula in Slovenia after a customer found some dead insects in a pack. (74)
- The recall affected the 28.22 oz pack with lot code 100762029 (expiry date 13-10-2019). (74)
Dumex Mamil Gold (Step 1) Infant Milk Formula (Singapore) Recall
- In August 2018, Dumex recalled this formula (30 oz) over possible contamination with Cronobacter sakazakii. (75)
- It affected batch number 09117R1 (expiry date 11-9-2019). (75)
Enfamil Formulas (CVS Store Recall)
In 2018, CVS temporarily removed all Enfamil formulas from stores across the US after one mom, Alison Denning, reportedly purchased a tampered container from a CVS location in Oldsmar, Florida. (76)(77)
Denning explained that the protective seal looked intact, but the interior seal was broken. Instead of formula, the contents looked like flour. (76)(77)
To be sure, she purchased another formula and compared the contents. (78)
She explained that the second formula looked slightly yellowish, was harder to pack, and looked a little more grainy. It confirmed her suspicion that the first container wasn’t baby formula. (72)
So, she reported the issue to the store. They offered her a refund, but Denning also reported the safety issue to Enfamil. Mead Johnson (Enfamil’s manufacturer) sent her a shipping box so they could test the product. (78)
CVS Pharmacy issued a recall of all Enfamil formulas and removed the rest of the stocks off the shelves, even before Mead Johnson tested the possibly tampered formula. (77)
After their respective investigations, Mead Johnson and CVS declared it an isolated incident. (77)
Enfamil didn’t recall the formula. But the company encourages everyone to check the package appearance before purchasing any of their products. The company explained that even minor differences in the packaging can hide a safety or tampering issue. (79)
They also assured customers that their products are safe, and welcome calls to their hotline (1-800-BABY123) from anyone who believes their formula might have been tampered with. (79)
Enfamil AR (Possible Product Tampering)
In 2018, Chelsea Bellinger of Buckeye, Arizona, bought a possibly tampered formula. She got an Enfamil AR formula from a Walmart location in Arizona. (78)
According to Bellinger, her husband prepared several formula bottles and put them in the fridge before sleeping.
Later, she noticed that the powder settled to the bottom of the bottles. (78)
She thought that her husband didn’t shake these bottles properly while preparing them. But after shaking the bottles, she was surprised when the powder still didn’t dissolve. (78)
She even heated the baby bottles but realized that the consistency didn’t look right. She saw that clumpy solids had formed at the bottom. She quickly dumped everything in the sink. (78)
Upon checking the powder in the container, she realized that the consistency and color of the product were different from the formula she usually buys. But she wasn’t sure what material was used to replace the formula. (78)
She reported the issue to Walmart. (78)
The company conducted an internal review and later declared it an isolated incident. (78)
Neither Walmart nor the brand issued a recall on the formula, but Enfamil encourages customers to check the packaging of any product they are buying for signs of tampering. (78)
Formula Recall 2017
Lactalis Nutrition Santé (LNS) Recall
- In December 2017, Lactalis Nutrition Santé (LNS) recalled products from Picot AR, Milumel, Celia, and Taranis for possible contamination with Salmonella agona. (80)
- The possibly contaminated formulas can cause gastrointestinal problems, vomiting, headaches, chills, diarrhea, fever, and abdominal cramps. (80)
- The formulas had a manufacturing date starting from February 15, 2017. (80)
Gerber Good Start Soy Formula (Possible Tampering)
- In May 2017, a two-month-old baby was rushed to a hospital in Arizona after consuming a Gerber Good Start Soy formula, which was believed to have been tampered with. (81)
- Police arrested Jennifer LaPlante over the incident. She reportedly replaced the contents with a mixture of baking flour, rice cereal, and sugar before returning the containers to the store for a refund. (81)
- Gerber didn’t issue a recall because it was considered an isolated incident. (81)
Formula Recall 2016
Sammy’s Milk Baby Food Recall
- In September 2016, the FDA recalled this formula by Graceleigh, Inc. for failing to meet infant formula regulations. (82)
- The product doesn’t meet the iron content minimum and isn’t tested for Cronobacter, a deadly pathogen. (82)
Formula Recall 2011
Enfamil Newborn (Store Recall)
In 2011, stores Supervalu, Walgreen Co, Kroger, and Wal-mart recalled Enfamil Newborn over reports that it can cause a rare bacterial infection. (83)
A 10-day-old infant in Missouri, Avery Cornett, reportedly died after drinking Enfamil Premium Newborn (lot number ZP1K7G). Initial investigations indicated that Cronobacter sakazakii, a deadly bacteria caused it. (83)
Amid the backlash from furious parents, Mead Johnson assured customers that their formulas are safe. (84)
Another infant died, and two others got sick but recovered while the investigation was in progress. Angry parents called for a boycott and sales plummeted. (83)(84)
The retailers quickly recalled or pulled out Enfamil Premium Newborn products off their shelves as a precautionary measure. (83)(84)
Numerous tests conducted by the CDC (Centers for Disease Control and Prevention) and the FDA showed that unopened cans of the product tested negative for the deadly pathogen.
The two government agencies issued a joint statement declaring the products as safe. They cleared Mead Johnson Nutrition Co.
They also revealed that Cronobacter was found in the following samples: (83)
- An open container of baby formula
- An open bottle of water used to prepare the formula
- Prepared infant formula
Because the sealed, unopened formulas from the manufacturer tested negative for the deadly pathogen, the agencies couldn’t determine how the contamination occurred. But they concluded that it must have happened sometime after the containers were opened. (83)
So, despite the separate incidents involving the same formula, the FDA and CDC declared that there isn’t any evidence that they were related. (83)
Neither Mead Johnson nor the FDA issued a product recall over the issue. (83)
But the FDA, CDC, and Mead Johnson remind parents to follow safe practices in preparing or storing baby formula to avoid possible contamination. (83)(84)
Formula Recall 2010
Similac Powdered Infant Formula Recall
- In September 2010, Abbott Laboratories Inc. recalled powdered baby formula products due to the possibility of small common beetle contamination (larvae, full-grown adults, or insect parts). (85)
- The issue was discovered during a quality review. (85)
- The affected products were produced at a plant in Sturgis, Michigan. (85)
- It affected over 5 million Similac infant formula containers. (86)
This infant formula recall included these Similac products: (86)(87)
- Similac Advance Powder DHA/AHA
- Similac Advance Early Shield Powder
- Similac Advance Sensitive Powder DHA/AHA
- Similac Advance LCP with Iron Powder
- Similac Isomil Advance Soy Powder
- Similac Go & Grow Milk Powder
- Similac Go & Grow Soy Milk Powder
- Similac Go & Grow Milk Early Shield Powder
- Similac Organic Powder DHA/AHA
- Similac Sensitive R.S. Powder
- Similac Sensitive with Iron Powder
- Similac Sensitive Early Shield Powder
- Similac Isomil Advance Soy/Iron Powder
According to the FDA recall notice, ingesting the beetle can cause intestinal discomfort, or your child might refuse to eat. But it poses no serious health risk of food poisoning. (86)
The voluntary recall included as many as 5 million Similac powder infant formula units sold in the US, Puerto Rico, Guam, and some Caribbean countries. (86)(87)
Liquid formulas weren’t included in this recall. (87)
After testing the recalled products, Abbott Laboratories Inc. assured customers that over 99.8% of the products were negative for beetle contamination. (88)(89)
Formula Recall 2007
Similac Special Care Ready-to-Feed Premature Infant Formula with Iron
- In May 2007, Abbott Laboratories Inc. recalled Similac Special Care Ready-to-Feed Premature Infant Formula with Iron (2-oz bottles) for having a lower iron content than the one indicated on the label. (90)
- According to the FDA advisory, premature babies fed with this formula may have a higher risk of developing iron-deficiency anemia. But there weren’t any serious medical complaints reported concerning this recall. (90)
Formula Recall 2006
Similac Liquid Ready-To-Drink Formula Recall
- In September 2006, Abbott Nutrition recalled Similac Advance With Iron and Similac Alimentum ready-to-drink formulas for a manufacturing defect that may decrease their vitamin C content. (91)
- These bottles had a missing special layer that keeps the air out. Air reacts with the formula, causing a decrease in vitamin C over time. (91)
- Although it doesn’t pose an immediate health risk, babies who don’t receive enough vitamin C may experience deficiency. Symptoms can include irritability with generalized tenderness. (91)
Affected products include:
- Similac Advance With Iron: lot 401895V, “use by” date of May 1, 2007
- Similac Alimentum ready-to-drink formulas: lot codes 40177RH and 40172RH, “use by” date of Nov. 1, 2007
- Similac Advance Hospital Discharge Kits, lot code 41699D5
Does Enfamil Have A Recall?
Enfamil Gentlease Recall 2006
In 2006, Gentlease powdered infant formula (lot number BMJ19, “best before date” code of “1 Jul 07”) was recalled due to possible metal particle contamination. The affected products might have metal parts up to 2.7 mm in size. (92)
According to the advisory, in the rare instance that your baby inhales the formula and it reaches their lungs, the metal particles may cause serious risks to their respiratory system and throat. (92)
Injury symptoms are likely to show up within four hours and can include the following: (92)
- Breathing difficulties
- Swallowing difficulties
According to Mead Johnson, around 41,464 cans (lot number BMJ19) have been distributed to retail stores across the US since December 16, 2005. (92)
Thankfully, there weren’t any illnesses or health incidents reported concerning this recall. (92)
Formula Recall 2005
Similac Advance with Iron Formula Powder Recall
- In February 2005, Abbott Laboratories recalled Similac Advance with Iron Formula Powder (12.9-oz cans) due to possible contamination with PVC (polyvinyl chloride) plastic particles. (90)
- This contamination was attributed to a manufacturing problem. (90)
- There weren’t any serious health problems reported concerning this recall. (90)
Formula Recall 2003
Mead Johnson EnfaCare LIPIL Recall
- In February 2003, Mead Johnson recalled EnfaCare LIPIL for possible Enterobacter sakazakii contamination. (93)
- It affected 505 cases of products distributed to retail stores, hospitals, and WIC (Women, Infants and Children program) clinics across the US in December 2002.
- Affected products were from lot code BME01 with an expiration date code of “1JAN04.” There weren’t any other lots or products affected by this recall. (93)
According to the recall advisory, the deadly pathogen may cause the following conditions in newborns, particularly premature babies and infants with weakened immune systems: (93)
- Meningitis (inflammation of the brain’s lining)
- Sepsis (bacteria in the blood)
- Necrotizing enterocolitis (a severe intestinal infection)
This recall alarmed many parents because the product is especially formulated for premature babies or newborns with special dietary requirements. (93)
Enfamil Nutramigen Recall (2001)
- In 2001, Mead Johnson Nutritionals recalled Enfamil Nutramigen ready-to-use liquid and powder formulas due to incorrect preparation instructions in Spanish. (94)
- As many as 4.6 million cans were affected by this recall. (94)
According to the advisory, following these incorrect instructions may lead to serious health problems. (94)(95)
Repeated consumption of the incorrectly prepared formula for several days may lead to the following: (94)(95)
- Irregular heartbeat
- Possibly even death
Babies living in hot climates or already ill (with other medical conditions) may have a greater risk of experiencing potentially fatal complications. (95)
This formula was distributed in the US, Puerto Rico, Guam, and the Dominican Republic. (95)
Affected products include 3.7 million cans of powder formula (16-oz) with the following lot codes: (94)
The recall also affected 930,000 cans of the ready-to-use version (32-oz) with these lot codes: (94)
In some places, the retailer stores were allowed to continue selling the formula. But they were told to put the correct preparation instructions on the packaging for customers to see. (95)
Is There A Recall On Enfamil Baby Formula 2021?
No. There hasn’t been any recall on Enfamil baby formula in 2021. But there were several in previous years:
- Enfamil Gentlease in 2006 for metal contaminants (92)
- Enfamil EnfaCare LIPIL in 2004 for Enterobacter sakazakii contamination (93)
- Enfamil Nutramigen in 2001 for potentially dangerous label errors (94)(95)
Is There A Baby Food Recall 2021?
There have been several baby food recalls in 2021:
- Parent’s Choice Rice Baby Cereal was recalled on October 8, 2021, for having inorganic arsenic content higher than the government standards. (96)
- Beech-Nut Single Grain Rice Cereal was recalled on June 8, 2021, for high arsenic levels, too. (97)
- Peppa Pig Chocolate Chip Cookies Gable Box was recalled on May 20, 2021, for undeclared egg content (allergen). (98)
Is Baby Formula Regulated In The US?
Baby formula is food often used as an infant’s sole source of nutrition. So, the FDA requires manufacturers to meet certain standards, including minimum amounts for 29 nutrients. (97)
But the FDA doesn’t need to approve these formulations before these can be marketed. Still, the FDA may recall formulas and baby foods that don’t meet these standards. (99)
Why Do Formulas Get Recalled?
Formulas are recalled if they don’t meet the FDA’s standards. (99)
But many recalls also involved contaminants or manufacturing defects.
What To Do If Your Baby’s Food Or Formula Has Been Recalled?
After any formula or food recall and safety alert, do the following:
- Check the product name, batch number, lot code, and the expiration or “use by” date.
- If it’s part of the recall, immediately stop giving it to your child. For the refund or replacement process, contact the store or manufacturer.
- Consult your pediatrician if your baby shows signs of stomach upset or other medical issues from drinking the recalled product.