FDA admits it knew about deadly bacteria in infant formula months before recall

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The Food and Drug Administration admitted to knowing about a deadly bacteria found in infant formula months before the product was pulled from store shelves, an FDA spokesperson confirmed to Politico.

On February 20, the FDA issued a press release from Reckitt announcing that two batches of the company’s Enfamil Prosobee Simply infant formula manufactured between August and September 2022 had been possibly contaminated with a deadly pathogen, Cronobacter sakazakii.

The Centers for Disease Control and Prevention reports that “Cronobacter infections in infants can be fatal.”

According to an FDA spokesman, the administration became aware that the formula had tested positive for contamination during a November inspection, months before the recall announcement.

The FDA claimed it did not follow up more thoroughly because it was a “limited inspection” and Reckett was still investigating the cause of the contamination.

During a February inspection, the FDA found that the company had failed to complete an adequate “sanitation break,” or proper cleanup, after the contamination.

The inspectors “obtained additional information that, when combined with the positive sample, raised the agency’s concern about the adequacy of cleaning in relation to the production of these two batches of products that are the subject of the recalled,” the FDA spokesman said.

The FDA and Reckitt noted that no illnesses related to the contamination had been reported.

Cronobacter contaminations have led to four formula recalls in the past year, more recalls than in the last ten years combined. In 2021, Abbott Nutrition recalled large quantities of its infant formula under similar circumstances.

Mitzi Baum, CEO of STOP Foodborne Illness, a nonprofit organization dedicated to preventing foodborne pathogens, told Politico that the FDA has not learned of past contaminations.

“It’s surprising that it’s almost identical to what happened in 2021,” Baum said. “No lessons learned.”

“The FDA remains reactive,” Baum continued. “It’s the internal processes that haven’t been fixed, if this happens again.”

An FDA spokesperson explained that the recent increase in recalls indicates an improved system, as recalled lots have been reduced.

“As part of FDA’s oversight to ensure safe and nutritious infant formula, the agency’s most recent engagements with manufacturers through ongoing inspections and meetings have limited the scope of these recalls and minimized disruptions to the market,” a spokesperson said. “Compared to the Abbott recall and temporary closure of the Sturgis facility, the recent recalls are much smaller in scope, affecting only a few weeks of product with no additional facility closures.”

Recett did not respond to a request for comment, Politico reported.

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