FDA warns recalled baby formula can cause serious illnesses

Container of Similac Pro-Total Comfort brand baby formula in Lafayette, California, December 28, 2021. Photo courtesy Sftm. (Photo by Gado/Getty Images)

The FDA is warning consumers not to use certain powdered baby formula produced at a plant in Michigan after consumer complaints of infant illnesses in several states.

Officials are 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 FDA said in a press release that it was investigating consumer complaints of Cronobacter sakazakii and Salmonella Newport infections that sickened four infants in three states. The infants in all four cases were hospitalized and Cronobacter may have contributed to a death in one case.

"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," said Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response. "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.

The FDA has initiated an onsite inspection at the facility, located in Sturgis, Michigan. The products made at the facility are available across the United States..

According to the FDA, Cronobacter bacteria 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. Cronobacter infection may also cause bowel damage and may spread through the blood to other parts of the body.

The FDA is continuing to investigate and will provide additional consumer safety information when it becomes available.

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