Government warnings were issued about three powdered baby formulas – Similac, Alimentum and EleCare -- after several children were sickened and one died after consuming the product.
The powdered infant formulas were found to contain Cronobacter bacteria or Salmonella, which can cause various and catastrophic injury.
The U.S. Food and Drug Administration (FDA) said it was investigating reports of four cases in which babies were hospitalized after ingesting the formula, including one who died.
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The formula in question was made at Abbott Nutrition’s Sturgis facility in Michigan but distributed nationwide, even to some foreign countries. The FDA, in concert with the Centers for Disease Control and Prevention (CDC), warned customers to avoid using or buying certain powdered infant formulas made at the Michigan plant.
The potentially affected Similac formula, Alimentum formula, EleCare formula products include those with the first two-digit codes 22 to 37; codes on the container of K8, SH or Z2; and expiration dates of dates of 4-1-2022 (April 2022) or later.
The FDA said it was doing an on-site investigation of the Michigan plant and has so far discovered several positive Cronobacter results from samples as well as “adverse inspectional observations” by its inspectors. It added that a review of the company’s internal records also indicated environmental contamination with Cronobacter and it noted that the company had destroyed some quantities of formula due to presence of the germ.
“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.
The reported illnesses – three from Cronobacter and one from Salmonella – occurred in Minnesota, Ohio and Texas, though the FDA noted the powdered baby formula was sold in the United States and also exported. The agency said its warning does not include liquid formula products or metabolic deficiency nutrition formulas. Those may still be used.
The Cronobacter bacteria can cause life-threatening infections or meningitis, the FDA said, noting symptoms can include poor feeding, irritability, temperature changes, jaundice, grunting breaths and abnormal movements. It advised that parents immediately call their child’s doctor if they notice any of these symptoms. The bacteria can also cause bowel damage and may spread through the blood to other parts of the body.
Salmonella can cause gastrointestinal illness and fever, with symptoms including diarrhea, fever and abdominal cramps and in more severe cases high fever, aches, headaches, lethargy, rashes, and blood in the urine or stool.
In a further instruction, the FDA said formula should never be diluted nor should homemade infant formulas be given to babies.
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