FDA Issues Recall Alert for Hypoallergenic Infant Formula

WASHINGTON — A popular hypoallergenic infant formula has been voluntarily recalled by its manufacturer due to possible Cronobacter sakazakii contamination.

The formula, Nutramigen Hypoallergenic Infant Formula Powder, is manufactured by Reckitt/Mead Johnson Nutrition.

According to an alert issued by the U.S. Food and Drug Administration on Sunday, the agency learned of the possible contamination of the product, which is used by infants with allergies to cow’s milk, from the Israeli Ministry of Health on Dec. 14.

The ministry told U.S. regulators that a contaminated sample was discovered during routine sampling of imported products at the Israeli border. It identified the sampled formula as having been produced at Mead Johnson Nutrition’s Zeeland, Michigan, facility.

The FDA says the notice led to a full scale investigation that included genome sequencing on the sample obtained from the infant formula to confirm the initial findings of Cronobacter species and to determine whether the isolate was Cronobacter sakazakii. 

Cronobacter sakazakii is a pathogen found naturally in the environment that can enter manufacturing facilities and home environments on hands, shoes and other contaminated surfaces. 

While infant formula firms are required to test a representative sample of their product for both Cronobacter and Salmonella species, this verification step does not guarantee the product is free of Cronobacter. 

Cronobacter contamination can occur at very low levels and is not evenly distributed throughout the product, making it difficult to detect. Powdered infant formula is not a sterile product and public health agencies, including the FDA, routinely encourage caregivers to take steps to prepare powdered infant formula as safely as possible. 

The FDA said Sunday that no illnesses have been reported in connection with the recall, and it is likely that most of the formula distributed in the United States has already been consumed.

Consumers who have Nutramigen Hypoallergenic Infant Formula Powder with the batch codes below are advised to stop using it and throw it away or contact Reckitt/Mead Johnson Nutrition for a refund:

• ZL3FHG (12.6 oz cans).
• ZL3FMH (12.6 oz cans).
• ZL3FPE (12.6 oz cans).
• ZL3FQD (12.6 oz cans).
• ZL3FRW (19.8 oz cans).
• ZL3FXJ (12.6 oz cans).

The products have a UPC Code of 300871239418 or 300871239456 and “Use By Date” of Jan. 1, 2025.

The FDA said though Nutramigen is a specialty infant formula, there are substitute infant formulas available. 

The agency further advises that if the infant formula a child uses is unavailable, parents and caregivers should work with their child’s health care provider to find a suitable substitute.

The FDA does not expect that this recall will have a major impact on the U.S. supply and availability of powdered infant formulas.

While the FDA’s inspection is ongoing, all testing conducted to date by the FDA and Reckitt/Mead Johnson Nutrition has been negative for Cronobacter.

The company, meanwhile, has initiated a voluntary recall of 675,030 cans of Nutramigen Powdered Infant Formula distributed to the United States.

Dan can be reached at [email protected] and @DanMcCue