Baby Formula Recall

Abbott issued a voluntary recall for certain lots of its baby formulas because of reports that babies got sick from Cronobacter sakazakii infection. All of the infected babies were hospitalized and two died. The CDC closed it’s investigation in May 2022 after a lab found the strains of Cronobacter in the two infants did not match samples of Cronobacter found at Abbott’s plant.

Cronobacter infections are especially dangerous for newborns, though they are rare. The bacteria can cause life-threatening blood infections (sepsis) and swelling in the membranes surrounding the spinal cord and brain (meningitis).

Parents have been filing NEC lawsuits against baby formula manufacturers Abbott and Mead Johnson, but these are unrelated to the Abbott Cronobacter recall. These baby formula lawsuits allege that Abbott and Mead Johnson knew their cow’s milk baby formulas could increase the risk of necrotizing enterocolitis or NEC, a potentially fatal intestinal disease, in premature babies.

Events leading up to the Abbott baby formula recall for Cronobacter began in September when the FDA received the first report of Cronobacter illness from the Minnesota Health Department.

While the FDA found numerous violations and contaminated surfaces in Abbott’s Sturgis, Michigan plant, testing did not find any bacteria in samples from customers with sick infants.

• February 2023: Reckitt issued a recall for 145,000 cans of Enfamil ProSobee Simply Plant-Based Infant Formula because of potential Cronobacter contamination. SEC and FTC began investigating Abbott in relation to its infant formula business.
• January 2023: The Justice Department’s consumer protection branch began investigating Abbott regarding its Sturgis, Michigan plant.
• August 2022: Abbott restarted Similac infant formula production at the Sturgis facility.
• July 2022: Abbott resumed production of EleCare and other specialty metabolic formulas metabolic formulas.
• April 2022: Abbott submitted a response and corrective action plan to the FDA on April 8 following the FDA’s inspection.
• March 2022: Abbott responds to the FDA investigation, saying: “While there are actions we need to take to address the FDA observations, it is important to note that no Cronobacter sakazakii or Salmonella was found in any of our testing of products distributed to consumers.”
• March 2022: FDA made its inspection of Abbott’s Sturgis, Michigan plant public. The inspection detailed that Abbott didn’t maintain clean surfaces used in producing and handling the powdered formula. Inspectors also found a history of Cronobacter contamination, including eight instances between fall 2019 and February 2022.
• February 2022: Abbott initiated a voluntary recall of certain Similac, Alimentum and EleCare powdered infant formulas manufactured at the Sturgis plant and stopped production at the facility.
• January 2022: The FDA sent inspectors to the Sturgis facility and began an investigation at the end of January.
• October 2021: FDA officials received a whistleblower complaint about safety violations at Abbott’s Sturgis, Michigan plant. The complaint included claims that employees had falsified records and failed to properly test the formula before releasing it.
• September 2021: FDA received the first complaint of Cronobacter illness from the Minnesota Health Department.

In March 2023, the FDA sent letters to infant formula manufacturers, packers, distributors, exporters, importers and retailers with recommendations for preventing future Cronobacter illnesses.

Then in May 2023, FDA released its Outline of FDA’s Strategy to Help Prevent Cronobacter sakazakii Illnesses Associated with Consumption of Powdered Infant Formula. The agency will strengthen regulatory activities and oversight related to the production of powdered infant formula, according to the document.

In February 2022, Abbott Laboratories recalled certain lots of its Similac, EleCare and Alimentum baby formulas manufactured at its Sturgis, Michigan, factory. The company recalled the lots for potential bacterial contamination.

Investigators found five different strains of Cronobacter sakazakii at the facility, but samples of product collected by the FDA were negative for Cronobacter.

The following products are included in the Abbott baby formula recall:

The Abbott facility which produces the recalled baby formula also makes other special infant medical foods that have not been included in the recall. These products haven’t been recalled because the FDA has determined that medical conditions may worsen without them.

Nevertheless, the agency warns that there may be some risk of Cronobacter contamination with these products and recommends parents check with their medical provider for alternatives.

Has My Baby’s Formula Been Recalled?

Not all of the lots from the listed brands above are part of the recall, and you can check your baby formula package to see if it’s included in the recall.

Check to see if the first two digits of the code printed on the bottom of the container are 22 through 37 and if the code contains K8, SH or Z2. Look to see if the expiration date listed is April 2022 or later. The recalled products have all three of these conditions.

Parents or caregivers can also enter the code on Abbott’s website to check if their formula is recalled. The FDA warns parents and caregivers not to use any Similac, EleCare or Alimentum formulas included in the recall.

If your baby consumed recalled formula, the FDA recommends stopping its use and asking your pediatrician about switching formulas. Watch for symptoms of potential Cronobacter infection, including: Irritability, jaundice, changes in temperature, poor feeding, grunting breaths, excessive crying or abnormal body movements.

If your baby shows any Cronobacter infection symptoms, contact your pediatrician or seek medical attention right away. You can fill out a MedWatch form online to report an illness or baby formula side effect to the FDA or call a Consumer Complaint Coordinator.

Mothers who have been supplementing breastfeeding with formula may be able to exclusively breastfeed. When it comes to choosing breastfeeding or formula, experts agree breast milk is preferred for babies.

Parents or caregivers should ask their baby’s medical provider for alternatives to recalled baby formula. These include other store or name brand formulas that have not been recalled. The Abbott baby formula recall has led to a formula shortage, and the company has increased production at its other plants to try and make up for the demand.

Breastfeeding is always a great alternative to formula feeding, but if a mother isn’t producing her own milk or can’t breastfeed, parents and caregivers may decide to try human milk banks. Typically, hospitals receive priority and supplies may be low, but individuals may contact a milk bank for pasteurized donor human milk. Check the Human Milk Banking Association of America for a donor bank in your state.

It may be tempting to try and make homemade baby formula from recipes you find online, but experts say it’s dangerous because the recipes might not be safe and won’t provide adequate nutrition. Don’t dilute formula you currently have to make it last longer. This could also result in lack of nutrients for the baby and result in severe, life-threatening consequences.

Don’t buy baby formula from third party distributors online, especially if it’s from outside the U.S. because the formula may be counterfeit or not follow the FDA’s guidelines for proper nutrition.