Infant formula recalled out of precaution over rare but deadly bacteria

The U.S. Food and Drug Administration (FDA) said Sunday that a brand of baby formula given to infants allergic to cow’s milk was being recalled over its potential contamination with Cronobacter sakazakii, which can cause a rare but potentially lethal infection in newborns.

Manufacturer Reckitt/Mead Johnson Nutrition (MJN) announced Saturday that it was voluntarily recalling select batches of its Nutramigen Hypoallergenic Powdered Infant Formula Products. The recall applied to certain batches in 12.6 and 19.8-ounce cans manufactured in June, July and August, with a use-by date of Jan. 1, 2025. The recall came after the bacteria was found in a sample outside the U.S., though supplies within the U.S. did not show any trace.

“All product in question went through extensive testing by MJN and tested negative for the bacteria,” the company said in a statement.

Anyone who bought Nutramigen should check the bottom of the can for an affected batch number, the FDA said, and dispose of any they find.

Cronobacter sakazakii is the same bacteria that sickened two infants this year, killing one and leaving the other with brain damage. The incidents got the germ onto the official watchlist of illnesses compiled by the U.S. Centers for Disease Control and Prevention (CDC) back in June. States are asked to report any Cronobacter infections to the CDC.

It’s also the same bacteria that sparked a nationwide formula shortage in 2022. The two infants sickened earlier this year had consumed powdered infant formula made by Abbott Nutrition, the company that was the epicenter of the 2022 crisis.

The infection killed one Kentucky child and gave a Missouri baby brain damage after they consumed Similac Total Care powdered formula manufactured by Abbott. Neither the company nor the FDA found a cause-and-effect link between Abbott’s facilities and the children’s illnesses. The bacteria is found naturally in the environment, including the home, and can get into formula that has been opened.

The agency said the new recall should not have an impact on overall supply.

The Nutramigen recall was done out of precaution, the FDA said.

“We are committed to the highest level of quality and safety, and it is for this reason that we have taken this measure,” Reckitt/Mead stated.

With News Wire Services