The FDA has confirmed five different strains of Cronobacter sakazakii bacteria at a production plant that makes infant formula that has been linked to four illnesses and two deaths.
None of the five different strains match two available samples from sick babies, according to an announcement from the Food and Drug Administration. The agency found four of the strains of the bacteria at the Abbott Nutrition plant in Sturgis, MI, and the company found one other.
The Centers for Disease Control and Prevention conducted whole genome sequencing on the two available patient samples and found that the Cronobacter strains do not match any filed in the National Center for Biotechnology Informatics (NCBI) database. Product samples collected by FDA at the facility were analyzed for Cronobacter and were found to be negative.
Federal public health officials at the FDA and CDC continue to warn parents and care givers to check any infant formula they have on hand for the following identifying information.
Certain Similac, Alimentum, or EleCare powdered infant formulas have been recalled. The products can be identified by the 7 to 9 digit code and expiration date on the bottom of the package. Products are included in the recall if they have all three items below:
- 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.
In addition to products described above, Abbott Nutrition has recalled Similac PM 60/40 with a lot code 27032K80 on cans or 27032K800 on cases.
The FDA and officials with Abbott Nutrition are continuing to investigate the situation. The production plant in Sturgis, MI, is not in operation.
Some parents have reported difficulty in finding replacement products to feed their babies.
“The FDA is working with Abbott Nutrition to better assess the impacts of the recall and understand production capacity at other Abbott facilities that produce some of the impacted brands,” according to the federal agency. “We are also working with Abbott Nutrition on safe resumption of production at the Sturgis, MI, facility. We will continue discussion with Abbott Nutrition and other infant formula manufacturers and consider all tools available to support the supply of infant formula products.”
Additional FDA information for parents and caregivers
If your regular formula is not available, contact your child’s healthcare provider for recommendations on changing feeding practices.
If you get infant formula through WIC, do not throw the formula out. Instead, take it to the store for a refund and exchange or call the company at 800-986-8540 to help you. WIC recipients should be able to obtain a different brand of similar formula. Call your local WIC clinic for more guidance. Also see:
More information on Cronobacter and infant formula is available on CDC’s website.
Recalled powdered infant formulas have the potential to be contaminated with
Cronobacter bacteria, which can cause severe, life-threatening infections including sepsis or meningitis, an 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 body movements.
Cronobacter infection 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 immediately notify your child’s healthcare provider and seek medical care for your child. Healthcare providers and health departments are encouraged to report any confirmed cases of Cronobacter sakazakii to CDC.
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