Similac Recall 2022 & Infant Formula Safety Alerts: What You Need To Know
Alternatives To Similac & Other Recalled Baby Formulas
Update: July 22, 2022
Amid the formula shortage following the massive Similac recall earlier this year, many parents continue to face challenges in finding products for their children.
Some options for you to try (US brands), with your pediatrician’s approval:
- Serenity Kids A2 Toddler Formula * (Use our code MHC for 15% off first-time orders, too!)
- Bobbie Organic Infant Formula
- ByHeart Baby Formula
Many parents also consider the following European formulas as the best organic options for their babies:
Please consult your healthcare provider before switching to these formulas. Many European formulas aren’t approved by the FDA, although many parents still prefer them over US brands.
Abbott Plant Reopens After Flooding
Update: July 10, 2022
After a three-week shutdown following massive floods in the area, the Abbott plant in Sturgis, Michigan, has finally reopened again on July 1, 2022. Abbott said it would restart EleCare production, upon reopening, followed by specialty and metabolic formulas. (1)
FDA Plans To Allow Overseas Formulas Beyond Shortage
The FDA plans on allowing the import of overseas formulas from temporary importers to go beyond the shortage in a bid to prevent it from happening again. (2)
The agency announced that it will issue further guidance in September regarding how these companies could meet their requirements to continue supplying formulas beyond mid-November. (2)
FDA Investigates Another Abbott Formula-related Baby Death
Update: June 22, 2022
The FDA announced that they received a report of another infant death last June 10. The baby reportedly consumed formula made by Abbott Nutrition. (3)
According to the FDA, the infant death reportedly happened in January. They’re now investigating the circumstances of the baby’s death. (3)
As of press time, Abbott’s Sturgis plant remains closed.
US To Import Baby Formula From Mexico
The White House recently announced Operation Fly Formula’s tenth flight to Fort Worth, Texas from Mexico, which will bring approximately 1 million pounds (equivalent to around 16 million 8-oz bottles) of Gerber Good Start Gentle infant formula. (4)
These flights will arrive starting on June 24. (4)
Newly Reopened Abbott Plant Shuts Again Due To Floods
Update: June 19, 2022
Just days after finally reopening since shutting down in February, Abbott Nutrition’s Sturgis plant closes again due to floods affecting the area. (5)
The shutdown came after severe thunderstorms hit Michigan, leading to power outages and flood damage. Some areas of the Abbott plant were flooded and will require re-sanitization before the plant can reopen once again.
Abbott has informed the FDA of this new setback and announced that formula production will likely be delayed for a few weeks. (5)
The company needs to conduct comprehensive testing with an independent third party to determine if the plant is safe to reopen. Once they get the FDAs go-signal, Abbott will return to EleCare production before restarting Similac and other formula lines. (5)
More Formulas From All Over The World
After President Joe Biden announced “Operation Fly Formula,” several shipments have arrived from across the world to help the US solve the formula shortage.
Formulas that arrived in June:
- 95,000 cans arrived in LAX for Walmart, Albertsons Companies, and The Kroger Company grocery stores from Australia. These two shipments of Bubs amounted to 380,000 lbs equivalent to approximately 4 million eight-ounce bottles. (6)(7)
- 200,000 8-ounce bottles of Kendamil formulas arrived at Dulles International Airport in Virginia from the United Kingdom. More are expected to arrive on three more flights in the coming weeks. (8)
- 44,000 pounds (equivalent to approximately 548,000 eight-ounce bottles) of specialty infant formulas Nestlé Health Science Alfamino and Alfamino Junior arrived at the Louisville International Airport from Switzerland. (7)
Formulas still to arrive starting in June or July:
- 686,350 cans equivalent to approximately 16.5 million 8 fl oz bottles of Similac NeoSure (for premature babies or low birthweight infants) and Similac Total Comfort (for infants with sensitive tummies) will be imported by Abbott from their manufacturing facility in Granada, Spain, starting in June and throughout the summer. (5)
- 750,000 cans of Danone formula, which is equivalent to 19 million 8-ounce bottles, will arrive from their manufacturing facility in Ireland in July. Their first shipment will be Aptamil First Infant Milk Stage 1 (formula for healthy babies). It isn’t ideal for premature infants or those with digestive and metabolic issues. (8)
Recalled Baby Formula Accidentally Sold In Canada
The CFIA (Canadian Food Inspection Agency) warned consumers who bought from Shoppers Drug Mart to check their products after the retail pharmacy giant accidentally sold recalled baby formulas from Abbott due to an “online error.” (9)
These were the same products recalled in February 2022 and had the following codes (found at the bottom of the package or container):
- The first two digits are numbers from 22 to 37
- The code contains K8, SH, or Z2
- The expiration date code starts from 4-1-2022 (APR 2022) and subsequent dates
The store is once again recalling these recalled infant formulas, which shouldn’t have been sold back to consumers at all.
Nine Baby Deaths Reported During FDA Investigation
Update: June 10, 2022
From December 1, 2021, to March 3, 2022, the FDA reportedly received a total of nine reports of formula-related baby deaths, with two among the four confirmed Cronobacter sakazakii infections that led to the February 2022 Similac recall. (10)
None of the DNA sequences in the FDA investigation matched the company’s products. However, all these infants were fed Abbott powdered formulas: (10)
- Similac Advance
- Similac Pro Advance infant formula
- Similac Pro-Total Comfort (Powder) infant formula
- Similac Total Comfort Easy-to-Digest Gentle Protein & Prebiotics
- Similac PM 60/40
- EleCare infant formula
Abbott Reopens Formula Plant, Starts EleCare Production
Update: June 6, 2022
Abbott Nutrition finally restarted its facility in Sturgis, Michigan, on June 4, 2022. It was the facility shut down in February following the massive Similac recall. (11)
The company announced that it will prioritize EleCare production as well as other specialty and metabolic formulas for babies with severe food allergies and digestive problems.
It will take around three weeks or June 20 before these formulas will hit market shelves. (11)
According to Abbott, it will also resume the production of Similac and other formulas as soon as possible.
The Sturgis plant’s reopening is expected to improve formula supplies in the market and alleviate the formula shortage problem soon.
Some Global Companies To Send Formulas As US Shortage Hits 70%
Update: May 31, 2022
The US formula shortage rates continue to rise, with the number reaching as high as 70% in the week ending on May 22, according to a report from Datasembly. (12)
Understanding the need for the international community to help solve the US crisis as more babies go hungry, several foreign baby formula companies offered to help.
The FDA relaxed some regulations to make it easier for foreign companies to import formulas to the US, while also assuring parents that these products meet US standards.
President Joe Biden had previously directed various agencies to import products from companies overseas that meet US standards using military planes through “Operation Fly Formula.” (13)
Some of the companies that offered to help:
- Bubs Australia – at least 1.25 million cans of baby formula (14)
- UK manufacturer Kendal Nutricare (makers of Kendamil) – around 100 trucks over the next six months (15)
Abbott Needs To Comply With Court Consent Decree Before Production Can Resume
Update: May 24, 2022
A consent decree filed at the US District Court for the Western District of Michigan created a legally binding agreement between Abbott and the FDA, with steps that the company had to comply with before production at the Sturgis facility can resume. (16)(17)
These are some of the steps they need to comply with: (16)(17)
- Hiring an independent third party expert who will review its processes
- Cleaning and sanitizing the entire facility, including all equipment
- Restarting all the equipment and completing test runs
- Checking all the ingredients
- Conducting multiple tests of all equipment
The company must also review and change the following: (16)
- Environmental monitoring program
- Product sampling
- Testing plans
- Employee training programs
If any contamination is detected, Abbott is required to immediately stop production. They also need to promptly notify the FDA about the situation. (17)
Abbott’s “Serious Steps” To Address The Formula Shortage
Abbott Laboratories CEO Robert Ford apologized for their role in the formula shortage, referring to the massive recall of Similac, Elecare, and Alimentum products in February 2022. (18)
Since Abbott has over 40% share of the US infant formula market, their formula recall and subsequent plant shutdown badly affected the formula supply. Although the formula shortage began in 2021, Abbott’s massive recall worsened the problem. (19)
According to Ford, none of the bacterial strains that caused the infection of four infants, killing two babies, were found in Abbott’s products. However, issuing the voluntary recall was the right thing to do because they didn’t want to risk the children’s lives and health. (18)
He explained that none of the data matched between the specimen from the four complaints and of the retained product samples. There wasn’t any connection between their products and the four reported illnesses. (18)
However, he clarified that they wouldn’t tolerate having bacteria in their plant, something that the FDA found during their investigation. (18)
Abbott’s head detailed the “serious steps” the company is taking to address the baby formula shortage: (18)
- “Rigorous inspections” of their products
- Acceleration of the production processes
- Creating a $5 million fund for children hospitalized due to lack of access to specialized products
- Converting production lines at their Columbus, Ohio, facility to prioritize the production of ready-to-feed liquid infant formula
- Air-shipping millions of widely used powdered baby formulas from an FDA-approved plant in Ireland to the US
Once the production resumes at Sturgis, Michigan, Ford detailed that they will do the following: (18)
- More than double the current production to help produce more products to address the shortage
- Make significant investments to improve facilities to ensure the issue doesn’t happen again
- Invest in upgrading safety and quality processes and equipment
FDA Refutes Abbott’s Claim Regarding Bacterial Strains
While Abbott maintains that the strains from the FDA’s investigations don’t match those taken from their facility, FDA officials recently refuted this claim. (13)
According to the FDA’s food director, Susan Mayne, they were unable to fully determine if there’s a match because they only had sequences from two babies. (13)
Groups Claim Abbott Enriched Shareholders While Plant Needed Repairs
Abbott reportedly enjoyed profits soaring as high as 94% between 2019 and 2021 even as bacteria was detected in its products during the same period. (20)
Two years before the recall, Abbott’s net profits increased from $3.6 billion to $7.1 billion, according to Securities and Exchange Commission records. (20)
Then, the company allegedly increased its dividends by over 25% and offered shareholders a stock buyback program worth $5 billion. (20)
This alarmed progressive economic advocacy group, Groundwork Collaborative. Rakeen Mabud, the group’s chief economist, pointed out that instead of improving its plant and making productive investments, Abbott chose to prioritize its shareholders. (20)
American Economic Liberties Project senior fellow Moe Tkacik accused companies like Abbott of using their products as a personal ATM. She added that buybacks were considered a form of manipulation and were illegal until 1982. (20)
Also, she believes that restrictions should be imposed on companies that receive federal funding or in Abbott’s case, companies whose largest customers are federal programs such as the WIC. (20)
However, Abbott denies that the buyback program hurt their products’ safety. Still, the experience pushed economists to call for bans on buybacks, stricter antitrust enforcement, and limits on shareholder dividends. (20)
A company spokesperson explained that their “strong balance sheet” allowed them to invest in improving their facilities even with the stock buybacks.
Senate To Investigate Abbott’s Safety Improvements & Buyback Program
The Senate Finance Committee recently announced through Senator Ron Wyden that they’re going to investigate Abbott’s investments in their plant’s safety improvements amid record revenues. (21)
Wyden has reportedly requested Abbott for more information regarding their stock buyback program. (20)
Pelosi Eyes Criminal Charges Over Baby Formula Shortage
House Speaker Nancy Pelosi said that there might be a need for indictment after the nationwide baby formula shortage is resolved. (22)
Although she called the shortage “unconscionable and tragic,” Pelosi didn’t specify the details of the possible “indictment.” However, she clarified that her remarks about the need for criminal charges aren’t associated with any of her colleagues. (22)
She further explained that it’s important to solve the problem as soon as possible. Although the indictment might be necessary to prevent a similar shortage from happening again, urgent action is necessary to protect the hungry, crying babies. (22)
Biden Invokes Defense Production Act
To directly address the formula shortage, Biden invoked the Defense Production Act on May 18, 2022. (13)
Under this act, suppliers must prioritize orders from infant formula manufacturers before any of their other customers who may have ordered the same goods. (13)
The first two Defense Production Act authorizations are “priority orders” for Reckitt Benckiser (Mead-Johnson’s Enfamil) and Abbott Nutrition: (23)
- For Abbott Nutrition – raw materials like sugar and corn syrup for infant formula
- For Reckitt – filters and other single-use products to generate certain oils needed in their infant formula production
Once the Abbott plant resumes operations, these priority shipments are expected to help increase their production by one-third. Reckitt facilities can also operate at their maximum capacity following these shipments. (23)
Biden Launches “Operation Fly Formula”
Aside from ramping up productions, Biden also launched “Operation Fly Formula.” He directed various government agencies to use the Department of Defense planes to pick up formulas that meet U.S. standards overseas and fly these to the U.S. to help restock shelves. (13)
Thanks to these special flights, shipments that normally take two weeks can reach the US within 72 hours. (24)
Formula Makers Import European Stocks To Help With US Shortage
Importing formulas is one of the Biden administration’s measures to help ease the ongoing shortage in the US. (25)
Formula makers quickly responded, with Nestle importing Alfamino from Switzerland and also Gerber Good Start Extensive HA from the Netherlands. (26)
According to a Nestle representative, these products serve a critical medical purpose because they’re for babies with cow’s milk protein allergies. It was easier to increase the shipments because both were already being imported even before the shortage. (26)
They have also increased production and “worked round the clock” to help meet the demand. (23)
The company representative added that they’re checking if they could tap into the Nestle global nutrition network for other formulas they could import after the FDA announced that companies are given temporary flexibility for importing baby formulas to address the shortage. (26)
The FDA is also planning to update its review process for more foreign manufacturers to ship more formula products to the US and boost imports. (23)
First European Shipment Arrives In The US
Through the “Operation Fly Formula,” the first batch of formulas (78,000 lbs) arrived in the US to supply specialty infant formula. (23)
White House National Economic Council director Brian Deese said that the Air Force cargo plane carried 15% of the specialty medical-grade baby formula needed in the US.
The shipment included 132 pallets of both the Nestle Health Science Alfamino Infant and the Alfamino Junior formulas. (24)
The products originated from Zurich, Switzerland, and were trucked to Germany. These were loaded on one C-17 cargo plane at Ramstein Air Base in Germany and flown to Indianapolis. The shipment was taken to the Nestle distribution center about a mile away for standard quality control checks. (23)
However, these specialty formulas aren’t expected to hit retail store shelves. Instead, they’ll be distributed to pharmacies, hospitals, and doctor’s offices first. Priority will be given to worst-hit regions, a Biden administration official said. (23)
These specialty formulas were prioritized because they’re in short supply in the US and serve a critical medical purpose for children with cow’s milk protein allergies.
Agriculture Secretary Tom Vilsack explained that this first batch can provide enough formula for around 9,000 babies and 18,000 toddlers for one week. (24)
More Formula Shipments Expected Soon
Another shipment with 114 pallets of Gerber Good Start Extensive HA formula from the Netherlands is expected to arrive via the second flight of Operation Fly Formula. (23)
This next shipment from Ramstein Air Base is expected to land in Pennsylvania for distribution by the Nestle facility in the area. (23)
The White House further announced that the first round of flights will carry a total amount of formula equivalent to 1.5 million doses of eight-ounce bottles. (24)
House Passes $28 Million Emergency Spending & WIC Flexibility Bills
Two House bills were passed to address the shortage.
One grants the secretary of the Department of Agriculture the permanent flexibility to issue waivers in the event of supply disruption. In particular, this measure will let WIC participants buy any formula from any available supplier rather than be limited by the unavailable WIC-approved brand. (25)(27)
This is significant because the WIC program (Special Supplemental Nutrition Program for Women, Infants, and Children) accounts for as much as 50% of infant formula sales in the US. (13)
To prevent a similar shortage from happening again, the bill also requires formula manufacturers to create a contingency plan to protect against supply disruptions in the event of a recall. (27)
The bill passed in the House with a large bipartisan majority vote. It was also quickly approved by the Senate and is now up to Biden to sign into law. (28)
However, although the second bill (emergency spending bill) was also passed, it was received with more resistance from Republican representatives.
Democrats also proposed a $28 million emergency spending bill to supposedly boost the FDA’s resources, including adding more staff. (13)
Democrat Rep. Rosa DeLauro, the chair of the House Appropriations Committee, explained that this will increase the FDA’s staff so more of them can do the following: (13)
- Inspect domestic and international suppliers
- Acquire better data on the marketplace
- Prevent fake or fraudulent products from reaching store shelves.
However, this bill has been met with resistance, with other lawmakers such as Rep. Bill Huizenga saying that more formula production is needed, not more FDA staff. (13)
Rep. Andy Harris, chair of the Appropriations subcommittee that funds the FDA, claimed that it wasn’t a money problem but a leadership issue. (27)
Republican House representatives filed a counter bill they call the “Babies Need More Formula Now Act” which aims to obtain formulas from overseas sources. (28)
Republican Conference Chair Elise Stefanik accused Biden’s “failed leadership,” saying that it’s responsible for America’s baby formula crisis. (28)
A total of 192 Republican lawmakers voted against the bill, claiming that “throwing millions of dollars at the problem won’t fix it.” (28)
The House’s budget measure is expected to meet more resistance in the Senate. Republicans are questioning why the FDA isn’t held accountable for the shortage and the possible lapses that led to the deaths of the two babies linked to the Abbott products. (21)
FDA Commissioner Faces Congress
FDA Commissioner Dr. Robert Califf is the first administration official to face Congress in an investigation of the baby formula shortage.
During a May 2022 bipartisan hearing, Rep. Rosa DeLauro and other lawmakers repeatedly asked the FDA head why the agency took several months to investigate a whistleblower complaint on safety violations at Abbott’s plant. However, Califf reportedly sidestepped these questions by saying that he can’t share details of the agency’s ongoing investigation. (29)
He admitted to reading the complaint but didn’t specify when or what steps he took to immediately address the issue.
Califf announced, instead, that Abbott could restart production in a week or two, pending safety upgrades and certifications. (29)
Consolidation Makes Formula Market Vulnerable
During the May 2022 hearing, FDA Commissioner Califf and lawmakers agreed that consolidation (strong market players taking over smaller competitions) made the US formula market more vulnerable to disruptions. (29)
Currently, 90% of the US formula market is dominated by just four players: (29)
- Reckitt Benckiser (Mead-Johnson’s Enfamil)
These four companies also dominate the federal contracts for the WIC program for low-income families, which accounts for 50% of US formula productions. (29)
So, major disruptions of these companies’ supplies, such as a massive recall like the February 2022 Similac recall, can greatly affect the formula supply in the market.
Before the massive Similac recall, Abbott Nutrition topped the market spot with 40% of the market share, closely followed by the long-time number 2 player in the US, Enfamil. However, the recall and Abbott’s plant closure elevated Enfamil to the top spot with 50% of the market share, Reckitt Benckiser claims. (30)
To meet the demands, Enfamil production has been increased to 30%, the company added. (30)
FDA Asks For More Budget
During the hearing before the House subcommittee, Califf asked lawmakers to increase the agency’s budget from last year’s $2.1 billion to $8.4 billion for food safety and nutrition. (21)
This huge increase includes a $76 million increase in food safety funding to improve technology to quickly trace the source of foodborne illnesses and other efforts to reduce toxins in food. (21)
Califf insisted that there’s a need for major improvements at the FDA, not because people were bad but because they needed the right resources and consistent leadership. (29)
Making Food Safety A Priority To Avoid Repeat Of Formula Crisis
Groups are calling on FDA officials to make food safety a priority to avoid a repeat of the formula crisis.
Congressional leaders and various groups also want to hold the FDA accountable for whatever lapses or responsibilities it might have overlooked that led to the Abbott plant closure and baby formula shortage.
Several groups are also calling on the FDA to restore the deputy food commissioner position removed during the Trump administration. They believe that having a leader in this position can unify and improve the FDA’s food program. (31)
Babies Hospitalized Due To Formula Shortage
In several parts of the US, several babies and even older children have been hospitalized amid the formula shortage.
Two Children Hospitalized Because Their Specialty Formula Is Out Of Stock
At least two kids have been hospitalized in direct connection with the formula shortage.
Dr. Mark Corkins, a pediatric gastroenterologist at Le Bonheur Children’s Hospital in Memphis, Tennessee, revealed that he admitted two patients because their specialty formula is out of stock. (32)
The two children (a toddler and a preschooler) were using EleCare, a specialty formula they needed because they both have short bowel syndrome and couldn’t absorb full-size proteins. (32)
They relied on the amino acids (building blocks of proteins) from EleCare for nourishment because these don’t have to be digested. After the recall, however, they had to try other formula options but were unable to tolerate them, leading to dehydration. (32)
According to Dr. Corkins, the preschooler has been admitted since April and remains at the hospital, while the toddler was only hospitalized for about a week.
The doctor explained that these kids didn’t have other illnesses and could have stayed at home. But they had to be hospitalized so they could be fed.
Babies Hospitalized For Intolerance To New Formula & Mineral Imbalances
Aside from these two children, at least three babies have been hospitalized at the Medical University of South Carolina Shawn Jenkins Children’s Hospital in Charleston, South Carolina, due to intolerance after their parents or caregivers tried other formulas due to the shortage. (24)
Another one was hospitalized due to mineral imbalances after their caregiver mixed their own formula. (24)
Undisclosed Number Of Children Hospitalized in Georgia
Some children with complex medical issues have been hospitalized for malnutrition at the Children’s Healthcare of Atlanta in Georgia, with some admitted back in February after the Abbott plant was closed. (33)
A spokesperson for the hospital refused to disclose the exact number of hospitalized kids but said that all had specific dietary needs. Any changes to their formula need to be carefully monitored to make sure they could be well tolerated. (33)(34)
For many of these kids, finding the right formula can be a long, complicated process to make sure that it can meet their nutritional needs while also ensuring it won’t trigger a potentially dangerous reaction, including dehydration or diarrhea.
Thankfully, the children have all been discharged. According to the hospital spokesperson, the kids ranged from babies to older children. (33)
Undisclosed Number Of Kids Hospitalized in Wisconsin
Jennifer Crouse, the Clinical Nutrition Manager of Children’s Wisconsin, disclosed that several children have also been admitted to their hospital or treated at the ER. (34)
Many of the kids presented with malnutrition or failure to thrive, particularly due to the lack of formula access. Some of the hospitalized kids suffered malnutrition after taking homemade formula or other inappropriate substitutions. (34)
Crouse said that the exact number of children hospitalized relating to the formula shortage isn’t available, but it’s apparent that they’ve had several of these admissions.
Children’s Wisconsin warns that homemade formula can cause liver and/or kidney damage. It can even lead to an imbalance in your baby’s body that might cause their heart to stop. (34)
Crouse added that there were also some parents who watered down the formula in hopes of stretching their supply. However, she warned that formula dilution can lead to organ failure or brain swelling. (34)
She encourages parents and caregivers to ask their pediatrician before giving any kind of formula substitute to their babies.
Abbott Nutrition To Reopen Sturgis Plant Involved In Recall
Update: May 13, 2022
The CDC (Centers for Disease Control and Prevention) announced on May 12, 2022, that it had closed the Abbott Nutrition investigation that linked the formula manufacturer to deadly Cronobacter infections. There weren’t any new cases identified as part of the investigation. (35)
The FDA clarifies that the recall is still in effect even though the investigation is closed.
They established an IMG (Incident Management Group) to continue working on these supply chain and food safety issues as the out-of-stock rates soared to 43%. (35)(36)
After getting involved in the massive Similac recall in February 2022, Abbott Nutrition recently announced that it plans to reopen the Sturgis, Michigan plant in about two weeks. This is subject to the FDA’s approval. (37)
Although it’s still unclear what impact this reopening might have on the baby formula shortage, Abbott Nutrition hopes that it can help improve the market supply.
However, even with the plant’s reopening, Abbott Nutrition estimates that the new products will only reach the store shelves in around six to eight weeks.
Abbott Nutrition acknowledges their role in the infant formula shortage. The company assures consumers that they have improved their protocols and systems at the facility.
Some of these facility improvements include the following: (37)
- Updating the protocols for cleaning, water, and maintenance procedures
- Upgrading the facility with the installation of sanitary floors that are easily cleanable and nonporous
- Reviewing and updating their training system, education, and all safety procedures applicable for employees and visitors
White House Announces Measures For Formula Shortage
US President Joe Biden met with infant formula manufacturers and retailers, including Reckitt, Gerber, Walmart, and Target, to discuss strategies to get more formula quickly yet safely onto store shelves to solve the ongoing shortage. (38)
The White House released the additional measures they will follow to increase the formula products available without compromising babies’ safety: (38)
Increasing Supply Through More Imports
The US typically produces nearly all (around 98%) of the infant formulas it needs. However, the baby formula shortage from supply chain issues and the Similac recalls reduced the available products. (38)
As the out-of-stock rates soared to 43%, the White House plans to increase formula importation from key sources, including Chile, Ireland, Mexico, and the Netherlands, to help meet the higher demands and lower supplies. (36)(38)
Cutting The Red Tape
The White House explains that manufacturers typically produce the same formula type in various package sizes to meet the demand. Around 50% of the market demand comes from the WIC program (Special Supplemental Nutrition Program for Women, Infants, and Children). (38)
For faster production, the Biden administration asked manufacturers to simplify product offerings. The USDA (United States Department of Agriculture) is also coordinating with various states to let WIC recipients purchase whatever products are in stock instead of being limited to WIC-approved options. (38)
Cracking Down On Price Gouging & Unfair Market Practices
According to the White House fact sheet, some unscrupulous retailers or individuals used the formula shortage to hoard products from legitimate suppliers. Then, they’re marking these up for online retail at exorbitant prices. (38)
As the formula shortage drove desperate parents to find online options, there were reports of products being offered on eBay for as high as $800, despite normally costing $43 to $47. (39)
Retailers like Target, CVS, and Walmart have since put a cap on the number of formula packs that consumers can buy online and from their stores. However, they’re still running out of formulas. (39)
President Biden asked the FTC (Federal Trade Commission) to investigate and monitor the perpetrators of this illegal and predatory conduct. (38)
The Similac Recall & The Formula Shortage
Update: May 11, 2022
With the ongoing infant milk formula shortage in the US, worried parents are having difficulty finding supplies for their babies. Retail companies like Walmart have already put a cap on how many you can buy per transaction. (40)
What caused this shortage?
Although the February 2022 Similac recall due to bacterial infections (discussed in detail below) is among the main causes of the formula shortage, authorities explained that supply chain issues and higher demands were already causing a shortage even in 2021. (40)
That’s why there’s also a shortage in the store brands like Walmart’s Parent’s Choice formulas produced by Perrigo.
As of May 8, 2022, market research company Datasembly estimates that 43% of the top-selling formula brands are out of stock. (36)
Abbott Nutrition Announces Release Of Some Products Amid Shortage
Update: May 4, 2022
Abbott Nutrition recently announced that they’re releasing some metabolic nutrition and specialty formulas amid the infant formula shortage. They’re doing it to fulfill the FDA’s request. (41)
However, the released products don’t include the recently recalled Similac, Alimentum, and EleCare powder formulas. (41)
Although one lot of Similac PM 60/40 was recalled, the rest weren’t included. So, Abbott includes this specialty product in the items being released along with these metabolic products: (41)
- 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
Abbott assures consumers that these products have been tested, weren’t included in the recall, and comply with all the product release requirements before distribution. (41)
The company clarified that these products are only available in limited quantities because production hasn’t resumed at the Sturgis facility. Instead, these products were those put on hold amid the recall.
They’re currently working with the FDA to implement corrective actions at the plant before they can resume production. But even if production starts again, Abbott explained that it could take at least 6-8 weeks before the products will be available for distribution. (41)
Abbott explains that the nutrition formulas will be released free of charge to patients but on a case-by-case basis and in coordination with healthcare professionals. (41)
Whistleblower Reportedly Notified The FDA About Security Lapses Months Before Recall
Update: April 29, 2022
House Appropriations Committee Chair Rep. Rosa DeLauro announced that her office received alarming documents from a whistleblower who used to work at the Abbott facility that produced the recalled Similac formulas in February. (42)
According to DeLauro, the whistleblower (name withheld for security reasons) wrote a 34-page report with a long list of allegations about security lapses and unsafe practices at the plant.
The whistleblower alleged that Abbott Nutrition: (42)
- Hid information during a 2019 audit by the FDA (Food and Drug Administration)
- Falsified records about several safety and quality concerns, including signing verifications without adequate knowledge, testing of seals, shipping products with fill weights lower than what’s on the label, failure to maintain accurate maintenance records, etc.
- Released untested infant formula
- Lack of traceability of their products
- Lax practices in terms of clean in place procedures
- Failed to take corrective measures after knowing their testing procedures were deficient
- Had an atmosphere of retaliation against employees who raised concerns about their company practices
The whistleblower claims that this report was submitted to the FDA in October 2021, several months before the deaths of the babies and the February 2022 recall. (42)
DeLauro expressed alarm that the FDA didn’t act quickly enough to check on the whistleblower’s report, considering that it involves the possible unsafe production of infant formula. (43)
“I am deeply concerned about the practices at this Abbott facility and their apparent failure to implement and enforce internal controls at this facility.
I am equally concerned that the FDA reacted far too slowly to this report.
“Why did the FDA not spring into action? Why did it take four months to pull this formula off store shelves? How many infants were fed contaminated formula during this time?”
In a statement, Abbott Nutrition wrote that they: (44)
- 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
Abbott claimed that they dismissed this former employee (the whistleblower) due to serious violations of the company’s food safety policies. After dismissal, the employee reportedly made the false allegations and submitted the false report to multiple authorities. (44)
The company insists that despite their products being the center of the issue, their investigations showed these aren’t the source of the infections. (44)
“The Cronobacter sakazakii that was found in environmental testing during the investigation was in non-product contact areas of our Sturgis facility and has not been linked to the two available patient samples or any other known infant illness.
A thorough review of all available data indicates that the infant formula produced at our Sturgis facility is not likely the source of infection in the reported cases and that there was not an outbreak caused by products from the facility.”
FDA Details Safety Issues At Abbott Plant Linked To Formula Recalls
Update: March 22, 2022
Findings released by federal safety inspectors on March 22, 2022, show that Abbott’s Sturgis, Michigan manufacturing plant involved in the recent Similac recall had several safety issues. (45)(46)
The FDA’s preliminary findings show the following: (45)(46)
- Failure to maintain the sanitary conditions of surfaces used to prepare and handle formula
- History of eight instances of Cronobacter bacteria contamination between fall 2019 and February 2022
- Failure to establish a system of process controls that covers all stages of processing to ensure that baby formula doesn’t become contaminated due to the presence of microorganisms (e.g., Cronobacter bacteria) in the formula or in its processing environment (35)
The Senate health committee asked Abbott to detail the amount of time it took them to start the recall from the first reported case. (45)(46)
In response, Abbott reportedly told the committee that the first report came in September from Minnesota health officials. The other reports were made from Ohio and Texas in the following months.
The FDA had actually conducted plant inspections in September. Federal inspectors found several safety violations: (35)(45)(46)
- Unsanitary conditions
- Absence of temperature controls
- Some employees failed to sanitize their hands
Surprisingly, however, the FDA didn’t issue a safety notice nor did they stop Abbott from producing formulas until the issues have been resolved. It’s unclear why that happened, but the FDA hasn’t issued a statement regarding this possible judgment lapse.
Food safety advocates are furious over how the FDA and Abbott handled these safety issues, especially because their lapses may have caused the death of at least two babies.
Experts point out that baby formula isn’t subjected to the same high temperatures that other foods undergo to kill potentially deadly bacteria and other germs. But something must be done to correct this serious safety concern.
They’re also asking for answers to get to the bottom of the problem and to ensure that infant formula contaminations wouldn’t happen again.
Abbott assured the public that they are “taking this very seriously and working closely with the FDA to implement corrective actions.” (45)(46)
The massive recalls worsened the formula shortage in the US that first started with supply chain issues.
You can read more about these formula recalls below.
Many formulas from name brands like Similac are designed to closely resemble breast milk.
But with so many options available, even from the same brand, finding the right formula for your baby can be a huge challenge for many parents.
Aside from checking the nutritional values and ingredients, it’s also a good idea to monitor for infant formula product recalls.
Moms may have different reasons for choosing a particular formula for their babies. Some might feel more secure choosing a well-known brand name.
Similac is among the most popular formula brands, but is it a healthy option for your baby? Have there been any formula recalls? If yes, what happened, and which products were included? Find the answers below.
Is There A Recall On Similac Formula?
Many parents are closely monitoring infant formula and baby food recalls because of recent Congressional Reports showing that many popular manufacturers are selling products tainted with high levels of toxic heavy metals.
The following are some of the Similac formulas that have been recalled:
Similac Recall (2022)
March 1, 2022 update: After the first recall on February 17, 2022, Abbott added another Similac product to the recall list. You can find more information about this recall below. (47)(48)
Similac Recall February 2022 (First Recall)
Similac recalls several powdered formulas for possible contamination that can cause Cronobacter sakazakii and Salmonella Newport infection. The recall was issued following consumer reports of four babies hospitalized, and one possible death due to Cronobacter. (47)(48)
- Date Recalled: February 17, 2022
- Company Name: Abbott Nutrition
- Reasons For Recall: Possible contamination with Cronobacter sakazakii and Salmonella bacteria (47)
- Affected Products: Similac, Alimentum, and EleCare powdered infant formulas
- Return or Refund Processing: 1-800-986-8540
Parents are advised to check the packaging of their Similac powdered formulas. The following are affected by this recall: (47)
- Similac, Alimentum, and EleCare powdered infant formulas
- The code at the bottom of the package or container contains K8, SH, or Z2
- The first two digits of the code are numbers from 22 to 37
- The expiration date code is 4-1-2022 (APR 2022) or later
The FDA issued the recall advisory after four infants from three different states (MN, OH, and TX) fell ill after reportedly consuming Similac powdered infant formula produced in Abbott Nutrition’s Sturgis, Michigan facility.
All four cases were hospitalized.
Authorities are now investigating after Cronobacter was found to have possibly contributed to the death of one of the babies. (47)
The FDA recall advisory announced:
“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.” (47)
Cronobacter can cause severe, life-threatening infections such as sepsis or meningitis (inflammation of the membranes protecting the brain and spine), according to the CDC (Centers For Disease Control And Prevention). (47)(49)
It may also cause bowel damage and can spread through the blood to other parts of the body.
Cronobacter infection can be deadly, especially to newborns. (49)
Symptoms of sepsis and meningitis can include: (47)
- Poor feeding or no appetite
- Low energy
- Temperature changes
- Grunting breaths
- Unusual movements
- Jaundice (yellow skin and whites of the eyes)
According to the recall advisory, products from Abbott Nutrition’s Sturgis, Michigan facility have been distributed across the US and likely to have been exported to other countries.
If your product is affected by this recall, don’t use it even if it looks alright.
Call Similac for refund processing or product replacement.
Here’s the statement from Abbott regarding this recall:
“Abbott is voluntarily recalling these products after four consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants who had consumed powder infant formula manufactured in this facility.
Additionally, as part of Abbott’s quality processes, we conduct routine testing for Cronobacter sakazakii and other pathogens in our manufacturing facilities. During testing in our Sturgis, Mich., facility, we found evidence of Cronobacter sakazakii in the plant in non-product contact areas. We found no evidence of Salmonella Newport. This investigation is ongoing.
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.” (48)
This recall doesn’t include any metabolic deficiency nutrition formulas, Abbott liquid formulas, or other nutrition products.
Abbott also reminds parents and caregivers that Cronobacter sakazakii can be commonly found in the environment and a variety of areas around the home. (48)
So, it’s important to follow the instructions found on the packaging for proper preparation, handling, and storage of all powder formulas to avoid contamination.
Similac Recall February 2022 (Second Recall)
- Date Recalled: February 28, 2022
- Company Name: Abbott Nutrition
- Reasons For Recall: Possible contamination with Cronobacter sakazakii bacteria (48)
- Affected Products: Similac PM 60/40
- Return or Refund Processing: 1-800-986-8540
Abbott voluntarily recalled one lot of Similac PM 60/40 with lot # 27032K80 (can) or lot # 27032K800 (case) also manufactured in the company’s facility in Sturgis, Michigan.
This recall was done after the death of another infant who tested positive for Cronobacter sakazakii. The baby had consumed Similac PM 60/40 from this lot.
The case remains under investigation, with authorities still trying to determine the cause of the infant’s Cronobacter sakazakii infection.
Abbott clarifies that no distributed product (Similac PM 60/40 or the previously recalled Similac, Alimentum, and EleCare powdered infant formulas) tested positive for the presence of Cronobacter sakazakii. (48)
Tests of retained product samples from the recalled Similac PM 60/40 lot were negative for Cronobacter.
Similac Formula Recall 2019
Similac TummiCare One Infant Formula Recall (Philippines)
- Date Recalled: August 14, 2019
- Company Name: Abbott Laboratories
- Reasons For Recall: Abbott recalled these products for differences in the preparation scoop size and the label instructions. (50)
- The formula is safe to consume, but incorrect preparation using the provided scoop might not provide enough nutrients for your baby’s normal growth. (50)
- Affected Products: Batch no. 03518QU (manufacturing date March 2019; expiration date March 2022)
- This voluntary recall only affected products sold in the Philippines.
- Return or Refund Processing: Contact 1800-10-995-1555 (Province), (02) 995-1555 (Manila), or [email protected]
Similac Baby Formula Recalls 2010
Similac Powdered Infant Formula Recall
- Date Recalled: September 23, 2010
- Company Name: Abbott Laboratories Inc.
- Reasons For Recall: Several powdered baby formula products were recalled due to the remote possibility of contamination with larvae, full-grown adults, or insect parts of the small common beetle. (51)
- It affected products made at a plant in Sturgis, Michigan. (51)
- The recall was based on an internal quality review. (51)
- Return or Refund Processing: Call 800-986-8850 or visit similac.com/recall (the company’s website for recalls)
This infant formula recall included these Similac products: (52)(53)
- Similac Advance Powder DHA/AHA
- Similac Advance Sensitive Powder DHA/AHA
- Similac Advance LCP with Iron Powder
- Similac Go & Grow Milk Powder
- Similac Isomil Advance Soy Powder
- Similac Go & Grow Soy Milk Powder
- Similac Advance Early Shield Powder
- Similac Organic Powder DHA/AHA
- Similac Sensitive with Iron Powder
- Similac Sensitive R.S. Powder
- Similac Sensitive Early Shield Powder
- Similac Isomil Advance Soy/Iron Powder
- Similac Go & Grow Milk Early Shield Powder
According to the FDA (U.S. Food and Drug Administration) recall notice, ingestion of the larvae or beetle could cause intestinal discomfort, and the child might refuse to eat. But it poses no immediate health risk of food poisoning. (52)
This voluntary recall included up to 5 million Similac powder infant formula units in plastic containers and 8-ounce, 12.4-ounce, or 12.9-ounce cans sold in the US, Guam, Puerto Rico, and some Caribbean countries. (52)(53)
No liquid formula products were included in this recall. (53)
Abbott Laboratories Inc. assured affected customers that their tests showed only 0.16% of the recalled Similac products were contaminated. (54)
“When we identified this, we did extensive testing of every product on the (factory) line, and more than 99.8 percent of the product was negative for beetle contamination,” said Abbott spokeswoman Melissa Brotz. (51)
The Similac recall involved dozens of different lots and products. Affected customers were advised to search for the lot number of their item at similac.com/recall. They can also find it from the list that the company later released. (55)
Similac Recalls 2007
- Date Recalled: May 2007
- Company Name: Abbott Laboratories Inc.
- Reasons For Recall: The formula has a much lower iron content than the concentration indicated on the label. (56)
- Affected Products: Similac Special Care Ready-to-Feed Premature Infant Formula Powder with Iron (2-ounce bottles)
- Return or Refund Processing: Call 800-624-3412
According to the FDA, premature babies fed with this formula for over a month may have a higher risk of developing iron-deficiency anemia because of insufficient iron intake. But there were no serious medical complaints reported concerning this Similac recall. (56)
Similac Formula Recalls 2006
Is There A Recall On Similac Alimentum? (Liquid Ready-To-Drink Formula)
- Date Recalled: September 18, 2006
- Company Name: Abbott Nutrition
- Reasons For Recall: The bottles had a missing special layer that keeps air out. This manufacturing defect may cause a decrease in the formula’s vitamin C content over time. (57)
- Infants who don’t receive enough of this vitamin might experience vitamin C deficiency. Symptoms may include irritability with generalized tenderness. (57)
- Affected Products: Lot 401895V, with a “use by” date of May 1, 2007
- Return or Refund Processing: Call 800-624-3412
Similac Advance With Iron (Liquid Ready-To-Drink Formula)
- Date Recalled: September 18, 2006
- Company Name: Abbott Laboratories
- Reasons For Recall: The formula bottles lack a special layer that keeps air out, leading to a possible chemical reaction between air and the formula that may decrease its vitamin C content. (57)
- Affected Products: Lot codes 40177RH and 40172RH, with a “use by” date of Nov. 1, 2007
- Return or Refund Processing: Call 800-624-3412
Similac Advance Hospital Discharge Kits
- Date Recalled: September 18, 2006
- Company Name: Abbott Laboratories
- Reasons For Recall: The bottles lack a special layer that keeps air out. It may cause a decrease in vitamin C levels over time. (57)
- Affected Products: Lot code 41699D5
- Return or Refund Processing: Call 800-624-3412
Similac Formula Recalls 2005
- Date Recalled: February 2005
- Company Name: Abbott Laboratories
- Reasons For Recall: Possible contamination with black polyvinyl chloride plastic particles (56)
- Affected Products: Similac Advance with Iron Formula Powder (12.9-ounce cans)
- Return or Refund Processing: Call 800-624-3412
The contamination was attributed to a manufacturing problem, but no serious health problems were reported concerning this recall. (56)
Is There A Recall On Baby Formula 2021?
The following are some of the baby formulas recalled in 2021:
Able Groupe Baby Formula Recall
- Date Recalled: August 08, 2021
- Company Name: Able Groupe
- Reasons For Recall: The recalled products didn’t meet FDA requirements because the company didn’t submit pre-market notifications. (58)
- Also, some of the formulas have low iron levels that didn’t meet the minimum of 1 mg iron per 100 calories. The FDA requires formula manufacturers to meet this requirement to help prevent iron deficiency anemia, a condition that can lead to irreversible functional development outcomes. (58)
- Formulas that don’t meet this requirement need a label indicating that additional iron might be necessary, but the company failed to comply. (58)
- Return or Refund Processing: Contact [email protected]
All lot codes of: (58)
These are imported products from Europe distributed by the online retail store LittleBundle website starting May 20, 2021. (58)
Designed by Nature Recall
- Date Recalled: June 14, 2021
- Company Name: Designed by Nature
- Reasons For Recall: Possible health risks due to incorrect labels (the product is not intended for use as infant formula) (59)
- The company doesn’t test for Cronobacter, a deadly bacteria. (59)
- Return or Refund Processing: Contact 562-354-0884 or [email protected]
These products are affected by the recall: (59)
- Goat’s Milk Powder
- Cow’s Milk Powder
- Base Milk Powder
What To Do With Recalled Milk Formula
- Double-check the full product name, lot code, batch number, and the expiration or “use by” date.
- If the product is part of the recall, immediately stop giving it to your child, especially recalled products with Salmonella and other pathogens. Contact the store or manufacturer for the refund or replacement process.
- Call your pediatrician or doctor if your child shows signs of medical issues (such as stomach upset) from drinking the recalled product.
Formulas That Haven’t Been Recalled
The following formulas haven’t been recalled:
- Similac Pro-Advance Non-GMO Infant Formula with Iron
- Earth’s Best Non-GMO Soy-Based Infant Powder Formula
- Kabrita Goat Milk Toddler Formula Powder
- Else Plant-Based Complete Nutrition for Toddlers
- Happy Baby Organics Infant Formula
- Enfamil Neuropro
- Enfamil A2 with Prebiotics
- Enfamil Enspire Baby Formula with Iron
- Meyenberg Whole Powdered Goat Milk
Always make sure to check with your baby’s pediatrician before starting or switching formulas.