FDA issues warning about baby formula that may be contaminated with dangerous bacteria

The US Food and Drug Administration issued a warning Friday about baby formula that may be contaminated with a bacteria that could be dangerous for infants.

On May 24, Dairy Manufacturers Inc. recalled 12.4-ounce containers of Crecelac Infant Powdered Goat-Milk Infant Formula with Iron 0 to 12 months, Farmalac Baby Powdered Infant Formula with Iron 0 to 12 months and Farmalac Baby Powdered Infant Formula with Iron Low Lactose 0 to 12 months because the products were not in compliance with all FDA infant formula regulations, the FDA said in a news release.

The company had not submitted the products for the required premarket notification before selling them in the US, the agency said.

The products are sold in stores in Texas and, the FDA said, possibly in other locations in the United States.

However, as part of the FDA’s ongoing investigation into the products, the agency said Friday, it found Cronobacter contamination in a sample of Crecelac formula. Limited sampling of other versions of the formula included in the recall did not turn up Cronobacter.

No illnesses have been reported in connection with the recall, but Cronobacter can cause serious infections of the central nervous system and the bloodstream and can lead to life-threatening conditions like sepsis and meningitis. In 2022, four cases of Cronobacter infections in infants - including two who died - triggered a large recall of infant formula that compounded a nationwide shortage.

In general, infants who get sick with Cronobacter can go on to develop brain abscesses, motor development problems, developmental delays and even death, according to the US Centers for Disease Control and Prevention.

Early symptoms of infection can include jaundice, abnormal body movements, irritability, poor feeding and a change in body temperature.

The FDA said it is working with Dairy Manufacturers and its distributors to make sure that the recall is carried out fully.

Parents and caregivers are advised not to give these particular brands to their infants, the FDA says. Those looking for goat milk infant formulas can find options that have completed the required premarket notification process and speak with their health care providers about possible alternatives.

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