FDA Issues Warning To Baby Formula Manufacturers

The Food and Drug Administration (FDA) issued warning letters to three baby formula manufacturers, the agency said Wednesday.

ByHeart Inc, Mead Johnson Nutrition (Reckitt), and Perrigo Wisconsin, LLC, each issued recalls in December 2022, February 2023 and March 2023, respectively, in response to their products potentially containing the bacteria Cronobacter sakazakii. 

It is the same bacteria that was found to contaminate Abbott Labs baby formula products manufactured at its Sturgis, Michigan, plant in early 2022. This contamination was linked to at least two infant deaths, and the eventual shut down of the facility triggered a devastating shortage of baby formula that carried into this year. 

The bacteria thrives in very dry places, like the inside of a baby formula canister.

The FDA is not currently telling consumers to dispose of any baby formula they purchased from the  manufacturers it warned this week, and the agency does not believe that any formula on the market is currently contaminated. 

“The FDA is issuing these letters now as part of its normal regulatory process and to reinforce to these firms the importance of instituting and maintaining appropriate corrective actions when they detect pathogens to ensure compliance with the FDA’s laws and regulations,” the statement says. 

The companies will need to conduct investigations to determine the cause of the contaminants that prompted recalls, and reevaluate their sanitation protocols before releasing more products onto the market. They will have 15 working days to inform the FDA of what measures they are taking to improve conditions. Regulators will assess whether their actions are sufficient when they next inspect the facilities. 

“The FDA is committed to identifying and acting on issues early to prevent any firms from reaching the level of concern that prompted last year’s large-scale recall and contributed to the infant formula shortage,” said Donald Prater, acting director of the FDA’s Center for Food Safety and Applied Nutrition, in the statement. “These letters are a reflection of this enhanced oversight.”