Reckitt/Mead Johnson issues voluntary recall of specialized Infant formula over potential bacterial contamination
Reckitt/Mead Johnson recalls Nutramigen Hypoallergenic Powdered Infant Formula due to potential bacterial contamination, as warned by the US FDA This specialty formula is designed for infants with cow's milk allergies
The US Food and Drug Administration issued a warning on Sunday about potential bacterial contamination of Reckitt/Mead Johnsons Nutramigen Hypoallergenic Powdered Infant Formula Products. The specialty formula is designed for infants with a cow's milk allergy.
After the Israeli Ministry of Health found Cronobacter sakazakii in exported formula, the manufacturers voluntarily recalled 675,030 cans of the product on December 29. This bacteria can cause rare but dangerous infections in newborns, and while it is naturally found in the environment, it can also contaminate powdered infant formula. The recalled cans had been distributed in the US, as well as exported to other countries.
The agency has reported no illnesses related to the product to date, and believes that most of the distributed product in the US has likely already been consumed.
According to the company's press release, all of the product in question underwent thorough testing and tested negative for the bacteria.
The FDA has advised consumers to discontinue use and immediately dispose of Nutramigen Hypoallergenic Infant Formula Powder with the following 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)
Consumers are encouraged to contact Reckitt/Mead Johnson Nutrition for a refund.
The products are identified by the UPC codes 300871239418 or 300871239456 and have a "Use By Date" of 1 Jan 2025.
While these products are specialty infant formulas, alternative options are available. It is recommended that users consult with their health care providers to find a suitable substitute.
Cronobacter was associated with the nationwide formula shortage in 2022, but the agency does not anticipate this voluntary recall will greatly affect formula supply.
On December 14, the Israeli Ministry of Health informed the FDA that a product tested at the Israeli border as part of routine sampling tested positive for the bacteria. Working with the FDA, Israel began whole genome sequencing of the products and on December 28, confirmed the presence of the bacteria.
The FDA began a for-cause inspection at Reckitt/Mead Johnson Nutrition's Zeeland facility on December 18. This included testing formula samples and environmental sampling. The inspection is still ongoing, but all testing conducted so far has been negative for Cronobacter.
