Similac Alimentum is a hypoallergenic, non-dairy baby formula popularly used for lactose intolerance, fussiness, cow’s milk protein allergy, gas, colic, and other food allergies.
It’s a formula trusted by parents to meet their babies’ needs, but is it safe?
As parents, we want the best, safest products for our babies. So, it’s important to monitor infant formula recalls or baby food safety issues.
Is there a Similac Alimentum recall? If yes, why was it recalled? Is liquid (ready-to-drink) Alimentum recalled? What symptoms can babies experience if they consume the recalled products? What formula has been recalled in 2022?
Find out below.
Alternatives To Recalled Infant Formulas (Amid The Shortage & Beyond)
Following the Similac recall (including Similac Alimentum) earlier this year and the subsequent formula shortage, many parents struggle to find options for their little ones.
The following are some infant formulas (US brands) for you to try, 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
*Check out our interviews with Serenity Kids founders on their toddler formula, and their baby food pouches.
These European formulas can also be the best organic options for your little one:
- Holle Organic (Bio)
- Hipp Dutch Combiotic Formula
IMPORTANT SAFETY REMINDER: Please consult your pediatrician or healthcare provider before switching formulas. Many European formulas don’t have FDA approval but are still preferred by many parents over US brands.
Is Similac Alimentum On Recall In 2022?
Yes, Abbott Nutrition issued a voluntary recall on several Similac formula products, including Alimentum, Elecare, and Similac powdered formulas, for possible bacterial contamination with Cronobacter sakazakii and Salmonella. (1)(2)
The recall was so big that it worsened the baby formula shortage problem in the US.
The following are the details of this recall:
- Date Recalled: February 17, 2022
- Company Name: Abbott Nutrition
- Reasons For Recall: Possible contamination with Salmonella and Cronobacter bacteria
- Return or Refund Processing: 1-800-986-8540
Check the packaging of your Similac powdered formulas for the following information if they’re included in the recall:
- The code at the bottom of the container or packaging contains K8, SH, or Z2 (see photo below).
- The first two digits of this code are numbers from 22 to 37.
- Check below this code for the expiration dates of April 1, 2022 (APR 2022) or later.
You can also enter the lot number on the Similac recall website (www.similacrecall.com) to check if the formula you have is among the recalled products.
The FDA (U.S. Food and Drug Administration) first issued a warning for consumers not to consume products made in Abbott Nutrition’s Sturgis, Michigan facility.
The safety warning was issued after four infants from three different states (Minnesota, Texas, and Ohio) reportedly fell ill after consuming Similac powdered infant formulas. All four cases were hospitalized.
Authorities are now investigating the matter after one of the babies died, reportedly due to a possible Cronobacter infection.
The FDA conducted tests and inspections in and around the facility, including reviewing their internal records to check for irregularities or issues that may have caused the contamination.
In its advisory, the FDA announced that their preliminary investigation showed the following: (1)
- Several positive Cronobacter sakazakii test results from environmental samples
- Unfavorable inspectional observations by FDA investigators
- Environmental contamination with Cronobacter sakazakii based on Abbott’s records
- Product destruction due to the presence of Cronobacter, again based on Abbott’s records
Here’s the statement from Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response:
“As this is a product used as the sole source of nutrition for many of our nation’s newborns and infants, the FDA is deeply concerned about these reports of bacterial infections.
We want to reassure the public that we’re working diligently with our partners to investigate complaints related to these products, which we recognize include infant formula produced at this facility, while we work to resolve this safety concern as quickly as possible.” (1)
According to the recall advisory, these products might have been distributed across the US and exported to other countries.
Discard affected products, even if they look alright. You can’t see these deadly pathogens, but they can be present in your baby’s formula.
Call Similac for refund processing or product replacement.
Why Is Alimentum Recalled?
This recall was issued following reports of four babies hospitalized, including one possible death due to Cronobacter. (2)
Abbott clarified, however, that the samples related to these complaints tested negative for the deadly pathogens. They also assure customers that all products undergo routine pathogen tests before release.
Still, Abbott and the FDA got some positive results for Cronobacter sakazakii. However, Abbott Nutrition explained that these were samples taken from non-product contact areas in their Sturgis, Michigan facility.
Here’s their statement 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.” (2)
In their statement, the company informs parents and caregivers that pathogens like Cronobacter sakazakii can be commonly found in various areas around the home, such as the kitchen, and the environment. (2)
It’s important to follow the package instructions for proper preparation, handling, and storage of all powdered formulas to reduce the risk of contamination.
What Are The Symptoms Of The Similac Recall?
Cronobacter is a deadly bacteria that can cause severe, life-threatening infections. These can include meningitis (inflammation of the membranes protecting the brain and spine) or sepsis (blood infection). (3)
This deadly infection can cause bowel damage, possibly spreading to other body parts through the blood.
The CDC (Centers for Disease Control and Prevention) explains that a Cronobacter infection can be deadly to babies, especially newborns. (3)
The following are the possible symptoms of sepsis and meningitis that a baby can experience after consuming a contaminated formula: (3)
- Poor feeding or no appetite
- Temperature changes
- Grunting breaths
- Unusual movements
- Jaundice (yellow skin and/or whites of the eyes)
Salmonella can cause salmonellosis, a gastrointestinal illness with fever.
The symptoms of a mild case can include the following: (4)
- Abdominal cramps
More severe cases can have the following symptoms: (4)
- High fever
- Body aches
- Blood in the urine or stool
- Prolonged vomiting
- Dehydration (very little urine, dry mouth and throat, and dizziness when standing up)
Severe cases can be deadly. (4)
If your baby experiences any of these above-mentioned symptoms, immediately notify your healthcare provider and seek medical attention.
Is Liquid Alimentum Recalled?
The 2022 Similac Alimentum recall doesn’t include any metabolic deficiency nutrition formulas, Abbott liquid formulas such as ready-to-drink Alimentum, or other nutrition products.
However, this product has been recalled in the past. (5)
Is There A Similac Alimentum Recall Before 2022?
Yes. Similac Alimentum Advance (liquid ready-to-drink formula) was recalled in 2006 for having a vitamin C content lower than the recommended minimum. (4)
- Date Recalled: September 18, 2006
- Company Name: Abbott Nutrition
- Reasons For Recall: The liquid ready-to-drink formula bottles had a missing special layer that keeps air out. This manufacturing defect can decrease the formula’s vitamin C content because the air reacts with the vitamin. (4)
- Babies who don’t receive adequate vitamins might experience vitamin C deficiency, leading to irritability with generalized tenderness. (4)
- Affected Products: Lot 401895V, with a “use by” date of May 1, 2007
- Return or Refund Processing: Call 800-624-3412
Formula Shortage News Updates
Judge Dismisses Some Court Cases Filed Against Abbott
Update: May 22, 2023
Some court cases filed against Abbott were dismissed by Chicago District Judge Matthew Kennelly. (60)
According to the judge, although the parents filed the cases with claims of economic loss over Abbott products’ supposed “substantial risk of bacterial contamination,” they weren’t able to prove they actually received contaminated products from the company and their children experienced bacterial infection. (60)
FDA Releases Improved Safety Measures For Powdered Baby Formula
Update: March 21, 2023
The FDA releases the following safety measures for baby formula manufacturers, retailers, packers, distributors, importers, and exporters to follow in order to protect infants, the most vulnerable population: (6)
- Making sure of full compliance with all relevant human food production rules and infant formula regulations
- Evaluating and also improving all the in-process controls and production stages (such as inspection of raw materials or ingredients and identifying manufacturing facilities’ areas of concern)
- Ensuring that any misbranded or adulterated formula is immediately reported to the FDA
The government agency also instructs all firms to inform them of any positive test results for Cronobacter spp. or Salmonella, whether or not the company has released the affected lot/s. (6)
FDA Official Resigns Over Criticism On Handling Of Formula Shortage
Update: January 26, 2023
FDA deputy commissioner Frank Yiannas of the Office of Food Policy and Response resigns from his position. He cited issues with the food program’s “decentralized structure,” which hampered their function and prevented them from working as an integrated team. (7)
His resignation came a month after the FDA was criticized in an independent review requested by Commissioner Robert Califf over their handling of the shortage crisis. It will be effective on February 24. (7)
According to the outside review, the FDA needs “a strong leader” to limit internal conflicts and there’s also a need for the food program to be reorganized. (7)
Justice Department Conducts Criminal Investigation Over Abbott’s Role In Formula Shortage
Update: January 24, 2023
The Justice Department’s consumer protection branch is reportedly conducting a criminal investigation over Abbott’s possible role in the US formula shortage. (8)
Parents continue to struggle with finding baby formula, especially those whose children relied on specialty formulas that are only manufactured by Abbott. (8)
The formula shortage even before Abbott issued the formula recall and shutdown in February 2022 due to Cronobacter contamination. However, the massive recall and the extended shutdown (they only reopened in June 2022) worsened the shortage. (8)
The company might be held liable for its big role in this shortage, depending on the Justice Department’s investigation. (8)
Abbott’s spokesperson, Scott Stoffel, said they’re “cooperating fully” with the Justice Department’s investigation. (8)
Previous FDA (Food and Drug Administration) investigations reported the discovery of several lapses and violations at Abbott’s manufacturing facility, including bacterial contamination on several occasions and lax safety protocols. (8)
Reckitt Benckiser Predicts Shortage Will Last Until Spring
Update: December 4, 2022
The US formula shortage crisis persists a year after it started, even with continued efforts by formula makers and the government to increase supplies. (9)
Yet things aren’t going to be any better soon as Enfamil maker Reckitt Benckiser predicts that the crisis will continue until spring. (9)
The company has ramped up production and is operating its formula factories 24/7, becoming the US’ largest formula supplier, a spot previously held by the trouble-hounded Similac. (9)
Abbott Reopens Plant Again After Flooding
Update: July 10, 2022
After a three-week shutdown caused by massive floods in the area, Abbott reopens its plant in Sturgis, Michigan, on July 1, 2022. The company announced that it would restart EleCare production and will soon begin with other specialty and metabolic formulas. (10)
FDA Plans To Continue Importation Of Overseas Formulas
Even when the shortage ends, the FDA plans to allow the continued importation of overseas formulas from the importers currently granted a temporary permit. (11)
The federal agency announced that guidance will be issued in September on how these overseas companies could meet requirements for supplying formulas beyond mid-November. (11)
FDA Receives Report Of Another Formula-related Infant Death
Update: June 22, 2022
The FDA recently announced that they received a report last June 10 about a baby who died in January, which might be related to their Abbott investigation. The baby reportedly consumed Abbott formula. (12)
The incident is now under investigation. (12)
16 Million 8-oz Baby Formula Bottles To Arrive From Mexico
Operation Fly Formula’s tenth flight will bring Gerber Good Start Gentle infant formula from Mexico to Fort Worth, Texas starting on June 24. (13)
The US plans to import around 1 million pounds (approximately 16 million 8-oz bottles) of this formula from Mexico. (13)
More imports are expected because Abbott’s Sturgis plant is still closed, and the formula crisis continues to affect the US.
Recalled Baby Formula Accidentally Sold In Canada
Update: June 20, 2022
The CFIA (Canadian Food Inspection Agency) warns consumers who bought formulas from Shoppers Drug Mart to check their products after the retail pharmacy giant accidentally sold recalled formulas from Abbott due to an “online error.” (14)
These were the same items recalled in February 2022 and have the following codes (found at the bottom of the container or packaging):
- 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 already-recalled infant formulas, which shouldn’t have been sold back to consumers at all. (14)
Abbott Plant Shuts Down Again Due To Floods
It has been just a few days since Abbott Nutrition reopened its troubled Sturgis plant, but the plant was forced to shut down again due to floods affecting the area. (15)
According to Abbott’s press release, they’ve informed the FDA about this new problem and will conduct comprehensive testing with the help of an independent third party to ensure that the plant is safe before reopening.
However, this means that production is once again delayed by a few weeks. Abbott had earlier announced that newly produced EleCare products will be on store shelves by June 20. (15)
After getting the FDA’s approval to resume production, Abbott will continue making EleCare before starting on Similac and other formula products. (15)
Formulas Arrive In The US From Across The World
President Joe Biden’s “Operation Fly Formula” has been busy picking up formulas from across the world to help solve the formula crisis in the US.
In the middle of June, several formulas have arrived:
- As much as 95,000 cans of baby formula arrived from Bubs Australia for Albertsons Companies, The Kroger Company, and Walmart grocery stores. Two shipments of Bubs formula arrived in LAX from Australia, bringing 380,000 lbs of infant formula or approximately 4 million eight-ounce bottles. (16)(17)
- Another 44,000 pounds or equivalent to around 548,000 eight-ounce bottles of specialty infant formulas Nestlé Health Science Alfamino and Alfamino Junior from Switzerland arrived at the Louisville International Airport. (17)
- US Vice President Kamala Harris greeted the shipment of 200,000 8-ounce bottles of Kendamil formula from the United Kingdom at Dulles International Airport in Virginia. More Kendamil formula cans will arrive on three more flights in the coming weeks. (18)
Other formula manufacturers are also planning to bring more formulas by the end of June and the rest of summer:
- Abbott will import 686,350 cans equivalent to 16.5 million 8 fl oz bottles of Similac NeoSure (made for premature and infants with low birth weight) and Similac Total Comfort (made for babies with sensitive tummies) from their facility in Granada, Spain. (15)
- Danone will ship around 750,000 cans equivalent to 19 million 8-ounce bottles of formula from their manufacturing facility in Ireland. The first shipment will be for Aptamil First Infant Milk Stage 1, a formula made for healthy babies but isn’t ideal for premature infants or those with metabolic and digestive issues. (18)
Nine Formula-related Infant Deaths Reported During Abbott Investigation
Update: June 10, 2022
The FDA reportedly received nine reports of formula-related infant deaths from December 1, 2021, to March 3, 2022. (19)
Two of these infant deaths were among four confirmed Cronobacter sakazakii infections which led to the Similac recall in February. Two other babies were confirmed to have Salmonella, while one had Escherichia coli. (19)
None of the DNA sequences in the FDA’s investigations matched Abbott’s products. However, all the babies reported above were fed different Abbott powdered formulas. (19)
Although this was also included in the recall, none of the fatalities received Similac Alimentum.
Abbott Restarts Formula Production At Sturgis Plant
Update: June 6, 2022
After shutting down in February, the facility in Sturgis, Michigan, is finally open again. (20)
Abbott Nutrition announced that production resumed on June 4, 2022, with the plant focusing first on EleCare and other specialty or metabolic formulas made for babies with severe food allergies or digestive problems.
It would take around three weeks for these formulas to hit market shelves, but Abbott estimates that the first ones will be out by June 20. (20)
Production of Similac and other formulas will also resume as soon as possible.
Now that the plant has resumed production, it is expected to help improve formula supplies and, hopefully, alleviate the US formula shortage soon.
International Companies To Send Formulas As US Shortage Hits 70%
Update: May 31, 2022
According to Datasembly, the formula out-of-stock rates across the US have reached 70% as of the week ending on May 22. (21)
As these numbers continue to rise, international companies have positively responded to the US’ call for help and announced that they will send formulas:
- Around 100 trucks of formula will be sent by the makers of Kendamil, UK manufacturer Kendal Nutricare, over the next six months. (22)
- Bubs Australia will also send at least 1.25 million cans of formula products to the US, while also assuring worried Australian parents that they have enough stocks to do this. (23)
To allow more companies to send formulas to the US, the FDA relaxed some regulations, but also assured parents that these formulas should still meet the US standards, as instructed by President Joe Biden.
States Hardest Hit By The Formula Shortage
Update: May 24, 2022
The out-of-stock rates soared to 50% in the following states in April 2022: (24)
- South Dakota
- North Dakota
Nevada reports that by May, it has also experienced a decrease of at least 50% of its infant formula supply. (25)
Biden Invokes Defense Production Act
To help solve the formula shortage, US President Joe Biden invoked the Defense Production Act on May 18, 2022. (26)
Under this act, suppliers are required to prioritize orders from infant formula manufacturers even if there are other customers who ordered the same goods. (26)
The first authorizations under the Defense Production Act are “priority orders” for Mead-Johnson’s Enfamil maker Reckitt Benckiser and Similac’s Abbott Nutrition: (27)
- For Reckitt – filters and single-use products used to generate certain oils needed in infant formula production
- For Abbott Nutrition – raw materials, including sugar and corn syrup
Reckitt facilities can operate to maximum capacity following these shipments, while production can increase to one-third once the Abbott plant resumes operations. (27)
Biden Launches “Operation Fly Formula”
Biden also launched “Operation Fly Formula” aside from ramping up productions of the baby formula manufacturers. (26)
The president directed various government agencies to use military planes of the Department of Defense to pick up formulas overseas (as long as they meet US standards) and fly them to the US to help restock shelves. (26)
Shipments that normally take two weeks can now reach the US within 72 hours, thanks to these special flights. (28)
First European Shipment Arrives In The US
The first batch of formulas (78,000 lbs) through the “Operation Fly Formula” arrived in the US to supply specialty infant formula. (27)
White House National Economic Council director Brian Deese shared that the Air Force cargo plane carried as much as 15% of the specialty medical-grade infant formulas needed in the US.
The shipment includes 132 pallets of: (28)
- Nestle Health Science Alfamino Infant formulas
- Nestle Health Science Alfamino Junior formulas
These specialty formulas serve a critical medical purpose for children with cow’s milk protein allergies. They’re currently in short supply in the US.
These came from Zurich, Switzerland, and were picked up by the US military planes from Germany and flown to Indianapolis. Upon arrival, the shipment was taken to the Nestle distribution center for standard quality control checks. (27)
However, because these are specialty formulas, they aren’t expected to hit retail store shelves yet. Instead, they’ll be delivered to pharmacies, hospitals, and doctor’s offices first. (27)
According to a Biden administration official, priority will be given to worst-hit regions.
More Formula Shipments Expected Soon
Thankfully, another shipment amounting to 114 pallets of Gerber Good Start Extensive HA formula is expected to arrive from the Netherlands in the coming days through the second flight of Operation Fly Formula. (27)
This next shipment is expected to land in Pennsylvania, again for distribution by the Nestle facility in the area. (27)
The White House announced that the first round of flights will carry formula equivalent to 1.5 million doses of eight-ounce bottles. (28)
Agriculture Secretary Tom Vilsack explained that this first batch of shipments can provide ample formula for one week for around 9,000 babies and 18,000 toddlers. (28)
House Passes WIC Flexibility & $28 Million Emergency Spending Bills
The House passed two emergency bills to address the shortage.
The first one was the largely uncontested bill that grants the secretary of the Department of Agriculture permanent flexibility to issue waivers in the event of supply disruption. (29)(30)
This measure will let WIC participants get any formula from any supplier rather than wait until the WIC-approved brand becomes available. (29)(30)
This is important because the WIC program (Special Supplemental Nutrition Program for Women, Infants, and Children) is dominated by the major brands and accounts for as much as 50% of baby formula sales in the US. (26)
The bill also requires formula manufacturers to create a contingency plan to prevent a similar shortage from happening again. It will protect against supply disruptions in the event of a recall. (30)
The bill was quickly passed in Congress and approved by the Senate. It’s now up to Biden to sign it into law. (21)
$28 Million Emergency Spending
The Democrats also proposed a $28 million emergency spending bill to supposedly boost the FDA’s resources, including adding more staff. (26)
However, it was received with more resistance from the Republican representatives. It was still passed by the House, but a total of 192 Republican lawmakers voted against it. They said that “throwing millions of dollars at the problem won’t fix it.” (31)
Democrat Rep. Rosa DeLauro, chair of the House Appropriations Committee, explained that the emergency budget will increase the FDA’s staff so they have more people to do the following: (26)
- Inspect domestic and international suppliers
- Prevent fake or fraudulent products from reaching store shelves
- Acquire better data on the marketplace
However, other lawmakers such as Rep. Bill Huizenga said that increased formula production is needed, not increased FDA staff. (26)
Republican House representatives filed a counter bill “Babies Need More Formula Now Act,” which aims to get formulas from overseas sources. (31)
Rep. Andy Harris, chair of the Appropriations subcommittee, claimed that it wasn’t a money problem in the FDA but a leadership issue. (30)
Republican Conference Chair Elise Stefanik also blamed Biden’s “failed leadership” for its responsibility in America’s baby formula crisis. (31)
The House’s emergency budget bill is expected to meet more resistance in the Senate.
Many Republican senators have questioned why the FDA wasn’t held accountable for the formula shortage. They also seek answers on the FDA’s possible lapses that may have led to the deaths of the two babies who consumed the Abbott products. (32)
FDA Commissioner Faces Congress
FDA Commissioner Dr. Robert Califf faced Congress in an investigation of the baby formula shortage in a May 2022 bipartisan hearing.
He was repeatedly asked by Rep. Rosa DeLauro and other lawmakers why it took the agency several months to investigate a whistleblower complaint about alleged safety violations at Abbott’s plant.
Califf admitted to having read the whistleblower’s complaint but didn’t specify the details or what steps he took to immediately address the issue.
He reportedly sidestepped the lawmakers’ questions by saying that he couldn’t share the details of the agency’s ongoing investigation. (33)
Califf announced, instead, that Abbott could restart production in a week or two, pending safety upgrades and certifications. (33)
Other points discussed in the hearing included the following:
FDA Asks For More Budget
Califf asked lawmakers to increase the FDA’s budget from $2.1 billion last year to $8.4 billion. He said that this will be used for food safety and nutrition. (32)
It includes a $76 million increase in food safety funding which will improve technology to trace the source of foodborne illnesses quickly. It will also improve efforts to reduce toxins in food. (32)
Califf explained that the FDA needs major improvements, not because the people were bad but because they really needed the right resources and consistent leadership. (33)
Groups Call For Food Safety Priority
Groups are calling on the FDA to prioritize food safety, including infant formula safety, to avoid a repeat of the formula crisis.
Various groups and congressional leaders want to hold the FDA accountable for possible lapses and the responsibilities it might have overlooked, which led to the Abbott plant closure and subsequent baby formula shortage.
They’re also calling on the FDA to restore the deputy food commissioner, a position removed during the Trump administration. This leader might be able to unify and improve the FDA’s food program. (34)
Limited Players Made Formula Market Vulnerable
During the hearing, the FDA commissioner and lawmakers agreed that having limited players due to consolidation (strong market players taking over smaller competitions) made the formula market more vulnerable to disruptions. (33)
As much as 90% of the formula market is dominated by four players: (33)
- Reckitt Benckiser (Mead-Johnson’s Enfamil)
They also dominate the federal contracts for the WIC program, which accounts for 50% of formula productions. (33)
So, any major disruptions of the companies’ supplies can greatly affect the formula supply in the market. That’s best exemplified by the massive February 2022 Similac recall that greatly worsened the formula shortage.
Before the February Similac recall, Abbott Nutrition topped the market spot with 40% of the market share. It was closely followed by the long-time number two formula player in the US, Enfamil.
However, Reckitt Benckiser claims that it now owns 50% of the market share after the Similac recall and Abbott’s plant closure. (35)
To meet the demands, Enfamil increased its production by 30%. (35)
FDA-Abbott Consent Decree For Production Resumption
Abbott announced that it could reopen its Sturgis plant in one to two weeks. However, they still need to comply with a consent decree that was filed at the US District Court for the Western District of Michigan. (36)
Abbott spokesperson Jonathon Hamilton revealed that a 33-page consent decree between the company and the FDA details steps they must comply with before production is allowed to resume. (37)
These steps include: (36)(37)
- Hiring an independent third party expert to will review processes
- Cleaning and sanitizing the plant facility and all equipment
- Restarting all equipment and running tests
- Conducting multiple tests
- Checking on all ingredients
They’re also required to review and change these: (37)
- Environmental monitoring program
- Testing plans
- Product sampling
- Employee training programs
If there’s any contamination detected, Abbott is required to immediately stop production. They need to promptly notify the FDA. (36)
Abbott CEO Apologizes, Details “Serious Steps” To Address Formula Shortage
Abbott had a 40% share of the US infant formula market in the US. So, its formula recall and plant shutdown affected the formula supply. It also worsened the formula shortage which began in 2021. (38)
Abbott Laboratories CEO Robert Ford acknowledges their role in the formula shortage as he apologized to the public. (39)
Ford clarified that none of the bacterial strains that infected the four infants and killed two babies were found in their products. (39)
According to the Abbott CEO, the data collected during their FDA’s investigation found no link between the Abbott retained products and those from the four complaints. (39)
Still, because the FDA’s investigation discovered some bacteria in their plant, Ford said they won’t tolerate that. He added that he holds high expectations of the company and they fell short of them. (39)
He believes the voluntary recall was the right thing to do for the company because they didn’t want to risk the children’s health and lives.
Ford detailed the “serious steps” Abbott is taking to address the formula shortage: (39)
- Acceleration of production processes
- “Rigorous inspections” of products
- Converting adult nutrition production lines in Columbus, Ohio, to prioritize ready-to-feed liquid infant formula production
- Air-shipping to the US millions of Abbott’s most popular powdered infant formula products from an FDA-approved facility in Ireland
- Creation of a $5 million fund for families whose babies have been hospitalized for not having access to the specialized products
Once production starts, Abbott will do the following: (39)
- Increase the current production by more than double the previous target
- Make significant facility investments to ensure the problem doesn’t happen again
- Invest in upgrading safety and quality processes
- Upgrade equipment
FDA Refutes Abbott’s Claim On Bacterial Strains
Abbott maintains that the bacterial strains sequenced in the FDA’s investigations from the alleged formula-related infant illnesses and deaths don’t match those taken from their plant in Sturgis, Michigan. (26)
However, FDA officials recently refuted this claim. (26)
Susan Mayne, the FDA’s food director, explained that they were unable to determine a link between Abbott products and the babies’ cases because they only had DNA sequences from two babies. (26)
Groups Claim Abbott Prioritized Shareholders Over Plant Repairs
Rakeen Mabud, chief economist of Groundwork Collaborative, claimed that Abbott chose to prioritize its shareholders instead of improving its facility and making productive investments. (39)
Abbott reportedly had profits as high as 94% between 2019 and 2021, but didn’t improve the facility even as bacteria was detected in some products during the same period. (39)
Net profits increased from $3.6 billion to $7.1 billion two years before the recall, according to Securities and Exchange Commission records. (39)
The company allegedly increased dividends by over 25% and offered a stock buyback program to shareholders worth $5 billion. (39)
Moe Tkacik, an American Economic Liberties Project senior fellow, accused companies like Abbott of using their products as personal ATMs. She added that buybacks used to be illegal until 1982 because they were considered a form of manipulation. (39)
She added that restrictions should be imposed on companies receiving federal funding or, as in Abbott’s case, those whose largest customers are WIC or other federal programs. (39)
In response, Abbott denies that the buyback program hurt any of their products’ safety. A company spokesperson added that their “strong balance sheet” even allowed them to improve their facilities even with the multibillion stock buybacks.
Still, economists are calling for a ban on buybacks, limits on shareholder dividends, and stricter antitrust enforcement. (39)
Senate To Investigate Abbott’s Buyback Program & Safety Improvements
After learning about the buybacks, the Senate Finance Committee, through Senator Ron Wyden, announced that they’re going to investigate Abbott’s investments in facility safety improvements amid their record revenues. (32)
Wyden also said that they requested Abbott for more information about their stock buyback program. (39)
Pelosi Eyes Criminal Charges Over Baby Formula Shortage
There could be an indictment once the nationwide baby formula shortage is resolved, House Speaker Nancy Pelosi announced. (41)
Pelosi didn’t specify the details of this possible “indictment” but called the shortage “unconscionable and tragic.”
However, she explained that it’s important to first solve the problem as soon as possible before the indictment to protect the hungry, crying babies. She added that filing criminal charges against those responsible for the formula crisis can prevent a similar shortage from happening again. (40)
She clarified, however, that the remarks about the criminal charges aren’t associated with her colleagues. (41)
Babies Hospitalized Due To Formula Shortage
In several parts of the US, several children have been hospitalized relating to the formula shortage. Most of the children had complex medical issues that required specialty formulas.
Finding the right formula can be a difficult, complicated process because it has to meet their nutritional needs but should trigger any potentially dangerous reaction, such as dehydration or diarrhea.
Two children (a toddler and a preschooler) who were using specialty formula EleCare were admitted to Le Bonheur Children’s Hospital in Memphis, according to pediatric gastroenterologist Dr. Mark Corkins. (42)
Both have short bowel syndrome, so they couldn’t absorb full-size proteins. (42)
They relied on EleCare’s amino acids (building blocks of proteins) for nourishment but the formula had been recalled. They had to try other options but couldn’t tolerate these other formulas, leading to dehydration. (42)
Three babies were admitted to Medical University of South Carolina Shawn Jenkins Children’s Hospital in Charleston for intolerance to new formula, while another was hospitalized due to mineral imbalances because their caregiver gave them homemade formula. (28)
An undisclosed number of children with complex medical issues have been admitted to the Children’s Healthcare of Atlanta in Georgia for malnutrition. The admissions began in February, right after the Abbott plant was closed. (43)
Thankfully, these children have all been discharged. (43)
According to a spokesperson, these kids had specific dietary needs, and any changes to their formula have to be carefully monitored to check if they could tolerate them. (43)(44)
Several children have also been admitted to Children’s Wisconsin or treated at the ER, according to Clinical Nutrition Manager Jennifer Crouse. (44)
Many of these kids had malnutrition which was linked to the lack of formula access. Some also suffered malnutrition after taking homemade formulas or other inappropriate substitutions. (44)
Crouse explained that some parents watered down the formula to stretch their supply. However, formula dilution can lead to brain swelling or organ failure. (44)
Children’s Wisconsin warns that homemade formulas can cause kidney and/or liver damage. It can also lead to severe imbalance that might cause a baby’s heart to stop. (44)
Crouse encourages parents and caregivers to ask their pediatrician’s advice before giving any kind of formula substitute to their babies.
Scammers Take Advantage Of Formula Shortage
Beware of scammers. That’s the advice from the FTC (Federal Trade Commission) as scammers are taking advantage of the situation and charging desperate parents hefty prices for formulas in fraudulent online stores. (45)
Some scammers created fake social media accounts or websites using brand logos to mimic the recognizable formula brands. Aside from selling highly marked-up products, many parents complained about orders that never arrived. (45)
5 Tips To Avoid Scammers
Some of the FTC’s recommendations to help you avoid getting scammed: (45)
- Use terms like “scam,” “review,” or “complaint” to research about the company, brand, or product you found online.
- Research about the company’s shipments and refund policies.
- Don’t pay using cryptocurrency, money transfer, or gift cards.
- Credit card payments can be ideal because you can process a refund if your order doesn’t arrive through buyer protection.
- Check for local resources because your pediatrician or local WIC office might already have available stocks.
AAP Lowers Age Recommendation For Cow’s Milk
An AAP (American Academy of Pediatrics) FAQ showed a lower age recommendation for cow’s milk. From the recommended age of one year old, the AAP now recommends giving it to babies who are at least six months of age amid the formula shortage. (46)
A Pediatrician’s Recommendation
There are risks to drinking cow’s milk, including an increased likelihood of anemia. However, Dr. Hanna Jaworski, division chief for Pediatrics at Spectrum Health, explained that it can be a better option than watered-down baby formula. (47)
She recommends choosing cow’s milk over diluted or homemade formula but only as a temporary “bridge” for a day or two. (47)
She also recommends limiting cow’s milk to just 24 oz or less and finding a close alternative to your baby’s formula as soon as possible. (47)
Cow’s milk should never be considered for babies with special health needs or using specialty formulas for allergies, even as a temporary substitute.
Ask for your pediatrician’s approval.
A Pediatrician’s Warning
Bronson Methodist Hospital pediatrician Dr. Megan Sikkema disagrees with the reduced age recommendation, warning parents to only follow it as a last resort. (47)
If you can’t help but give your baby cow’s milk, she recommends making it as short as possible. Once you find some formula, be sure to switch back immediately.
If you’re giving cow’s milk to your baby, she also recommends including iron-rich food in their diet if they’re ready to eat solid foods.
Harmful DIY Baby Formula Recipes Go Viral
Beware of harmful DIY baby formula recipes you find on social media. Many have gone viral as parents search for alternatives amid the formula shortage. (48)
The FDA advises parents against making homemade baby formulas because these could lack vital nutrients to support their baby’s growth.
One baby has already been hospitalized after suffering from mineral imbalances due to homemade formula. (28)
Did Ukraine Relief Shipments Cause The US Formula Shortage?
No. The formula shortage was due to supply chain issues and the massive Similac recall in February.
Operation Ukraine, a Mississippi-based nonprofit organization, is receiving hate on social media after getting mistakenly blamed for the US formula shortage due to their Ukraine relief shipments. (49)
Kathy Cadden founded the group some 22 years ago after learning of the plight of orphanages in Ukraine after the Soviet Union breakup.
Since the Russia-Ukraine war began, the organization has sent infant formula amounting to 60,000 four-ounce servings to the area. (49)
The shipments are small compared to the US formula production. However, a post showing screen grabs of news reports about their Ukraine relief shortly before the formula shortage made people hate the group.
Cadden explained that she didn’t create the problem, but she received threats from people who accused her of “killing American babies” and “working for Satan.” (49)
The group has since suspended collecting baby formula donations amid the US shortage.
Abbott Nutrition Releases Some On-hold Formulas Amid Shortage
Update: May 4, 2022
Amid the baby formula shortage, the FDA reportedly requested Abbott Nutrition to release some specialty and metabolic nutrition formulas needed particularly by babies in hospitals and others with special dietary considerations. (50)
So, Abbott announced that they’re releasing some of these products to fulfill the FDA’s request.
The metabolic nutrition formulas will be provided for free to patients. However, because stocks are limited, they’re only available on need (case-by-case basis) and in coordination with healthcare professionals. (50)
The company clarified that these nutrition formulas are available in limited quantities because they haven’t resumed production at the Sturgis facility. These products are those put on hold amid the recall.
Abbott assures customers that all these products have been tested. The items comply with all the release requirements before product distribution. (50)
The main products included in the February 2022 recall (Similac, Alimentum, and EleCare powder formulas) won’t be included in the release.
However, because only one lot of Similac PM 60/40 was affected by that, the stocks from other lots will be released again. (50)
Products for release: (50)
- 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
- Similac PM 60/40
- Tyrex-1 and 2
In the press release, Abbott explained that they’re still working with the FDA to address the situation and make corrective actions at the facility before production resumes. (50)
However, the company explained that it would take at least 6-8 weeks after production resumption before any of the newly produced infant formula products would be available for distribution.
Whistleblower Reported Abbott’s Security Lapses To FDA Months Before Recall
Update: April 29, 2022
A whistleblower who used to work at Abbott Nutrition in Sturgis, Michigan (the facility that produced the recalled Similac formulas in February 2022) claimed that he reported the company’s security lapses to the FDA in October 2021. (51)
That’s several months before the deaths of two babies linked to Similac products, and the subsequent massive recall of various infant formula products made by Abbott Nutrition. (51)
According to House Appropriations Committee Chair Rep. Rosa DeLauro, they received a copy of the whistleblower’s alarming 34-page report. (51)
Rep. DeLauro expressed alarm that the FDA didn’t act quickly on this whistleblower’s report. Whether it was true or not, DeLauro believes that the plant should have been inspected to verify the reports about the possible unsafe production of baby formula. (52)
In this report, the former employee alleged that Abbott Nutrition experienced and covered up numerous security lapses and unsafe practices at the Sturgis plant. He believes that the babies’ deaths could have been prevented if the company had followed proper safety protocols. (51)(53)
The following are among the whistleblower’s long list of allegations about Abbott Nutrition: (51)(53)
- The managers may have “sanitized” certain files to hide information before the 2019 FDA audit
- The company falsified records about safety and quality concerns: such as signing verifications without enough knowledge, “tampering” with maintenance records (such as time code removal), shipping products with weights lower than the product label, etc.
- After discarding contaminated samples, the company released untested infant formula
- Lax practices in keeping the place clean
- Lack of product traceability
- The company didn’t take any corrective measures even after learning that certain testing procedures were deficient
- An atmosphere of retaliation against their employees who raised concerns about their unsafe company practices
Abbott Nutrition issued a statement to deny the whistleblower’s allegations. The company said that this whistleblower had actually been dishonorably dismissed over serious violations of the company’s food safety policies. (54)
The dismissed employee made the false report and submitted it to multiple authorities, including the FDA, after his dismissal.
The company insists that their Similac products weren’t the infection sources of the contaminated products, based on internal investigations. (54)
Abbott also maintains that they follow these protocols: (54)
- Take employee concerns, especially about the products, very seriously
- Foster a culture of compliance to make the highest quality baby formulas
- Empower workers to identify and also report issues that might compromise any of their products’ safety and quality
FDA Reveals Safety Issues At Abbott Plant
Update: March 28, 2022
Federal safety inspectors released their preliminary safety report after conducting an inspection at Abbott’s Sturgis, Michigan manufacturing plant involved in the massive Similac recall. (55)(56)
The FDA shared these preliminary findings: (55)(56)
- Failure to maintain sanitary conditions, especially on surfaces used to prepare or handle formula
- Some workers entered the production area without properly sanitizing their hands and shoes
- History of instances of Cronobacter bacteria contamination (eight times) between fall 2019 and February 2022
- Failure to establish a process control system that covers all stages of processing; this safety system ensures that baby formula isn’t contaminated by microorganisms (e.g., Cronobacter bacteria) in the processing environment or within the formula’s ingredients (57)
The Senate health committee asked Abbott to detail the amount of time it took them to issue the recall from the first reported case. (55)(56)
In response, Abbott admitted that the first report came in September from Minnesota health officials. Then, other reports were made from Ohio and Texas in the following months.
The FDA even conducted plant inspections in September 2021. Federal inspectors found several safety violations: (55)(56)(57)
- Unsanitary conditions (e.g., dirty counters, trash under the tables)
- Lack of temperature controls
- Some employees entered the production area with unsanitized shoes or failed to sanitize their hands
Surprisingly, however, the FDA did not stop Abbott from producing formulas even if they noted these safety concerns on their inspection report. They didn’t issue a safety notice or recall of infant formulas until reports of the infant deaths came in.
It’s unclear why the FDA didn’t do anything, but lawmakers and parents are now asking for answers over this possible judgment lapse.
They’re furious over how the FDA and Abbott handled these serious safety issues, considering that these possible lapses may have caused the death of two babies.
Also, this isn’t the first time that Abbott was involved in possible bacterial contamination. The FDA had also inspected the plant several times before 2021, yet the latest safety inspections were treated as routine.
Consumer Reports director of food policy Brian Ronholm said: (58)
“The FDA knew back in 2019 that microbiological testing going on at Abbott’s plant was insufficient and later found that there was surface contamination from a dangerous bacteria at the facility.
It seems evident that the agency should have acted sooner. There will be plenty for the FDA to review about their enforcement process when this investigation concludes.”
Experts explain that one possible reason for the bacterial contamination is that baby formula isn’t subjected to the same high temperatures as those other foods undergo to kill pathogens. What’s clear, however, is that something must be done to correct this serious safety concern.
Food safety advocates are for answers to get to the bottom of the problem. No one wants another infant formula contamination issue to happen again.
Abbott assures the public that they’re “taking this very seriously and working closely with the FDA to implement corrective actions.” (55)(56)
They explained that their quality systems can detect the presence of pathogens, that’s why they had internal records of destroying some batches due to Cronobacter sakazakii in the finished products. These weren’t distributed to customers. (58)
An Abbott spokesperson said: (58)
“We have already begun implementing corrective actions and enhancements at the facility, leveraging new technology and strengthening our processes, to give parents and customers renewed confidence in the quality of manufacturing at our Sturgis plant when we restart operations there.”
They also insisted that the samples collected from the plant didn’t match the Cronobacter sakazakii microbes from the reported cases.
Abbott hasn’t confirmed how many formula units have been recalled. However, these include Similac, Alimentum, and EleCare (first recall), then Similac PM 60/40 (second recall).
These massive recalls worsened the formula shortage in the US which began with supply chain issues.
What Formula Has Been Recalled In 2022?
Update: December 12, 2022
Baby nutrition company ByHeart voluntarily recalled five batches of Whole Nutrition Infant Formula on December 11, 2022, due to possible cross-contamination with Cronobacter sakazakii. Infections are rare but can be deadly to infants.
Ready-to-Feed Liquid Products Recalled Over Bottle Cap Concerns
Update: October 16, 2022
In mid-October 2022, Abbott Nutrition voluntarily recalled some lots of liquid ready-to-feed products (2 fl oz or 59 ml bottles) due to possibly improperly sealed bottle caps, which can result in spoilage. (2)
According to Abbott, ingesting these spoiled products can cause diarrhea, vomiting, and other gastrointestinal symptoms. (2)
The affected products were manufactured by Abbott’s facility in Columbus, Ohio. Affected ready-to-feed brands: (2)
- Similac 360 Total Care Sensitive
- Similac 360 Total Care
- Similac Pro-Total Comfort
- Similac Stage 1
- Similac Special Care 24
- Similac NeoSure
- Similac Water (Sterilized)
- Pedialyte Electrolyte Solution
These ready-to-drink bottles were distributed to some retailers, distributors, hospitals, and doctor’s offices in these areas: (2)
- Puerto Rico
- Dominican Republic
- Trinidad & Tobago
- St Thomas
- St Croix
WARNING: Don’t feed any of these recalled ready-to-feed products to your baby.
Abbott Nutrition explained that only “a small percentage” of their products are included in this recall. (Read our Similac recall article for the complete list of affected lots)
Contact Abbott Nutrition for more information:
- US: 1-800-986-8540
- Puerto Rico: +1 787-622-5454
Similac, Alimentum, & Elecare
Aside from Similac Alimentum being recalled in February 2022, as mentioned above, this recall also included Elecare and other Similac powdered infant formulas.
They’re recalled for the same reason: possible Cronobacter sakazakii and Salmonella bacteria contamination.
In January 2022, the FDA recalled “Healthy Beauty” Angel Formula by Moor Herbs for failure to meet FDA requirements. For example, the products exceeded the maximum allowable levels for iron, potassium, and sodium. (59)