Hypoallergenic baby formula recalled due to possible bacteria contamination

Over 675,000 cans of hypoallergenic baby formula have been recalled due to the possibility of bacteria contamination.

Reckitt/Mead Johnson Nutrition, a producer of nutrition products, has voluntarily chosen to recall select batches of Enfamil-brand Nutramigen Hypoallergenic Infant Formula Powder from the U.S. market due to the possibility of Cronobacter sakazakii contamination in product sampled outside the U.S., according to an announcement posted by the U.S. Food & Drug Administration on Sunday.

Nutramigen Powder is a specialty infant formula designed to be consumed by babies with cows' milk allergies. The recall includes the following product batch codes:

• 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 were distributed through retail stored nationwide, primarily in June, July and August. They have a UPC Code of 300871239418 or 300871239456 and “Use By Date” of Jan. 1, 2025. The company believes most, if not all, of the recalled products have already been consumed and there have been no reports of illnesses. Anyone who has the recalled product should dispose of it, and can contact Reckitt/Mead Johnson Nutrition for a refund.

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Cronobacter bacteria, which was linked to the formula shortage that occurred in 2022, can cause severe, life-threatening conditions in infants. Cronobacter infections are rare but can be deadly in infants, with the potential to cause sepsis or swelling of the linings around the brain and spinal cord. About two to four cases are reported to the U.S. Centers for Disease Control each year. 

On Dec. 14, the FDA was notified by the Israeli Ministry of Health that Nutramigen hypoallergenic powdered formula produced at Reckitt/Mead Johnson Nutrition's Michigan facility tested positive for Cronobacter bacteria during routine sampling. On Dec. 18, the FDA commenced a for-cause inspection at the Michigan facility that included testing of formula samples and environmental sampling. The inspection is ongoing, but the FDA said all testing conducted to date has been negative for Cronobacter.

FDA officials do not believe this recall will have a major impact on the U.S. formula supply. There are substitute infant formulas available for those who need specialty hypoallergenic formula, the FDA said.