The FDA, along with CDC and state and local partners are investigating four consumer complaints of infant illness related to infant formula products from Abbott Nutrition’s Sturgis, MI, facility.

As of today, four infant illnesses have been reported. Three are cronobacter infections and one is a Salmonella infection. One death has been reported. Infants became ill between Sept. 6, 2021, and Dec. 2021. Sick people reside in Minnesota, Ohio, and Texas.

The implicated product was distributed nationwide and has expiration dates through 2022. The company has initiated a recall.

All of the sick infants are reported to have consumed powdered infant formula (IF) produced from Abbott Nutrition’s Sturgis, MI, facility.  All four patients were hospitalized and Cronobacter is believed to have contributed to a death in one case, according to the Food and Drug Administration.

The FDA has initiated an onsite inspection at the facility. Findings to date include several positive Cronobacter results from environmental samples taken by FDA and adverse inspectional observations by FDA investigators. A review of the firm’s internal records also indicates environmental contamination with Cronobacter sakazakii and the firm’s destruction of products because of the presence of Cronobacter.

The FDA is issuing this advisory to alert consumers to avoid purchasing or using certain powdered infant formula produced in the Sturgis, MI, facility.

This is an ongoing investigation and the firm is working with the FDA to initiate a voluntary recall of the potentially affected products.  FDA is continuing to investigate.

Recommendation

The FDA is advising consumers not to use Similac, Alimentum, or EleCare powdered infant formulas if:

• the first two digits of the code are 22 through 37 and
• the code on the container contains K8, SH, or Z2, and
• the expiration date is 4-1-2022 (APR 2022) or later.

The code is printed on the product packaging near the expiration date. Additional information on products made by Abbott Nutrition is available on their website: https://abbottnutrition.com/infant-and-new-mother.

The FDA advisory does not include liquid formula products or any metabolic deficiency nutrition formulas.

Products made at the Sturgis facility can be found across the United States and were likely exported to other countries as well.

These powdered infant formulas have the potential to be contaminated with Cronobacter, a bacterium that can cause severe foodborne illness primarily in infants. Cronobacter infections are rare but are especially high risk for newborn infants (see symptoms below).

Parents and caregivers should never dilute infant formula and should not make or feed homemade infant formula to infants.

More information on Cronobacter and infant formula is available on CDC’s website.

Cronobacter bacteria can cause severe, life-threatening infections (sepsis) or meningitis (inflammation of the membranes that protect the brain and spine). Symptoms of sepsis and meningitis may include poor feeding, irritability, temperature changes, jaundice (yellow skin and whites of the eyes), grunting breaths, and abnormal movements. Cronobacterinfection may also cause bowel damage and may spread through the blood to other parts of the body.

If your child is experiencing any of these symptoms, you should notify your child’s healthcare provider and seek medical care for your child immediately. Healthcare providers and health departments are encouraged to report any confirmed cases of Cronobacter sakazakii to CDC.