The FDA and CDC today announced babies are becoming ill from Similac powered instant formula produced at the company’s Sturgis, Michigan facility. At least one infant death has been reported after contracting a cronobacter sakazakii bacterial infection.
“All of the ill patients are reported to have consumed powdered infant formula produced from Abbott Nutrition’s Sturgis, MI facility,” the CDC said today. “As of February 28, CDC has announced one additional illness ofCronobacter sakazakii with exposure to powdered infant formula produced at Abbott Nutrition’s Sturgis, MI facility.Cronobacterinfection may have been a contributing cause of death for this patient. In total, this investigation includes four reports ofCronobacter sakazakiiinfections in infants (three from FDA complaints and one from a CDC case finding) and one complaint of aSalmonellaNewport infection in an infant. All five (fourCronobacterinfections and oneSalmonellaNewport infection) illnesses resulted in hospitalization andCronobactermay have contributed to death in two patients.”
The FDA has issued the following statement:
The most recent patient was reported to have consumed Abbott Nutrition’s Similac PM 60/40 product with the lot code 27032K800 prior toCronobacter sakazakiiinfection.FDA and CDC informed the firm of these findings and on February 28, 2022, Abbott Nutrition voluntarily recalled Similac PM 60/40 powdered infant formula with the lot code 27032K800. This is a specialty formula for certain infants who would benefit from lowered mineral intake and was not included in the previous recall.
At this time, Similac PM 60/40 with lot code 27032K80 (can) / 27032K800 (case) are the only type and lots of this specialty formula being recalled.
This particular lot of Similac PM 60/40 was distributed to the U.S. and Israel. If your regular formula is not available, contact your child’s healthcare provider for recommendations on changing feeding practices.
We understand that infant formula is the sole source of nutrition for many infants and is an essential product. 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. We are also working with Abbott Nutrition on safe resumption of production at the Sturgis, MI facility. FDA is continuing to investigate and will update this advisory should additional consumer safety information become available.
Recommendation
The FDA is advising consumers not to use recalled Similac, Alimentum, or EleCare powdered infant formulas. Recalled products can be identified by the 7 to 9 digit code and expiration date on the bottom of the package (see image below). 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 (can) / 27032K800 (case). At this time, Similac PM 60/40 with lot code 27032K80 (can) / 27032K800 (case) are the only type and lots of this specialty formula being recalled.
Additional recall information for theinitial recallis available on the FDA website. Parents can also enter their product lot code on thecompany’s websiteExternal Link Disclaimerto check if it is part of the recall.
Additional Information for Parents and Caregivers:
The recalls do not include liquid formula products. Consumers should continue to use all product not included in the recalls.
Parents and caregivers should never dilute infant formula andshould not make or feed homemade infant formula to infants. Consumers should also avoid purchasing imported formula through online sales, as it has the potential to becounterfeit.
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, you should take it to the store for a refund and exchange or call the company at 1-800-986-8540 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 onCronobacterand infant formula is available onCDC’s website.
Recalled powdered infant formulas have the potential to be contaminated withCronobacter, a bacterium that can cause severe foodborne illness primarily in infants.Cronobacterinfections are rare but are especially high risk for newborn infants (see symptoms below).
Cronobacterbacteria can cause severe, life-threatening infections (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 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 ofCronobacter sakazakiito CDC.