01 nutramigen fda recall
CNN  — 

On Sunday, the US Food and Drug Administration warned consumers of possible bacterial contamination of Reckitt/Mead Johnson’s Nutramigen Hypoallergenic Powdered Infant Formula Products. The specialty formula is a hypoallergenic infant formula used by infants allergic to cow’s milk.

The manufacturers voluntarily recalled 675,030 cans of the formula on December 29 after the FDA was notified that exported formula tested positive for Cronobacter sakazakii by the Israeli Ministry of Health. The Cronobacter bacteria can cause rare but potentially deadly infections in newborns. It’s present in the environment but is also known to contaminate powdered infant formula. The recalled cans of formula had been distributed in the US and additional product exported.

The agency notes that no illnesses have been reported to date and that most of the product distributed in the US has likely already been consumed.

“All product in question went through extensive testing,” the company said in its press release, “and tested negative for the bacteria.”

The FDA says consumers with Nutramigen Hypoallergenic Infant Formula Powder with the below batch codes should not use the product and and throw the formula away immediately. Consumers can 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 1 Jan 2025.

Although this product is a specialty infant formula, there are substitute infant formulas available and the agency suggests users work with their health care providers to find a substitute.

Cronobacter was linked to the national formula shortage in 2022, but the agency does not believe this voluntary recall will have a significant impact on formula supply.

On December 14, the Israeli Ministry of Health notified the FDA that product tested at the Israeli border as part of routine sampling tested positive for the bacteria. Consulting with the FDA, Israel initiated whole genome sequencing of the products and confirmed the presence of the bacteria on December 28.

On December 18, the FDA immediately commenced a for-cause inspection at Reckitt/Mead Johnson Nutrition’s Zeeland facility which included testing of both formula samples as well as environmental sampling. The FDA’s inspection is currently ongoing, but all testing to date has been negative for Cronobacter.