Nutramigen formula recalled over possible bacterial contaminationon Sunday. Reckitt/Mead Johnson issued a voluntary recall of 675,030 cans of Nutramigen Hypoallergenic Powdered Infant Formula following a warning by the US Food and Drug Administration (FDA) about potential bacterial contamination.
This recall, triggered by reports from the Israeli Ministry of Health, concerns the presence of Cronobacter sakazakii, a bacteria known for causing rare but severe infections in newborns, especially in those allergic to cow's milk.
The Israeli Ministry of Health, on December 14, informed the FDA that routine sampling at the Israeli border detected Cronobacter sakazakii in exported formula. Subsequent whole genome sequencing confirmed the bacteria's presence on December 28. This led to a "for-cause inspection" at Reckitt/Mead Johnson Nutrition’s Zeeland facility by the FDA, starting December 18. The ongoing inspection includes extensive testing of formula samples and environmental sampling. Despite this, all tests in the U.S. have been negative for Cronobacter to date.
Cronobacter sakazakii, while rare, poses a significant risk to infants, potentially leading to severe infections or meningitis. Symptoms can range from poor feeding, irritability, and temperature changes to more severe signs like jaundice and abnormal movements. The Centers for Disease Control and Prevention (CDC) highlights the seriousness of these infections, noting that a newborn infected by Cronobacter sakazakii died just 13 days after the onset of illness last year.
The FDA advises consumers with the Nutramigen Hypoallergenic Infant Formula Powder from specific batch codes to immediately cease use and dispose of the formula. These batch codes include ZL3FHG, ZL3FMH, ZL3FPE, ZL3FQD, ZL3FRW, and ZL3FXJ, with UPC Codes of 300871239418 or 300871239456 and a “Use By Date” of 1 Jan 2025. Consumers can contact Reckitt/Mead Johnson Nutrition for a refund.
“All product in question went through extensive testing,” the company stated in its press release, “and tested negative for the bacteria.”
Despite the recall, the company assures that most of the distributed product in the U.S. has likely been consumed without incident, as no illnesses have been reported to date. The recall notice indicates, "Based on the limited availability of the remaining stock of this special infant formula, it is believed that much, if not all, of the products recalled in the United States have been consumed."
This recall is notable as Cronobacter was linked to the national formula shortage in 2022. However, the FDA does not anticipate a significant impact on formula supply from this recall. The agency suggests that consumers work with healthcare providers to find suitable substitute formulas.
Customers who have purchased Nutramigen should check the bottom of the can for the affected batch numbers and contact the company for a refund at 866-534-9986 or by emailing firstname.lastname@example.org.
The recall applies to select batches of Nutramigen Powder, sold in 12.6 and 19.8 ounce cans, manufactured in June 2023, and primarily distributed in June, July, and August.
The vigilance of the FDA and the responsive action of Reckitt/Mead Johnson highlight the importance of safety measures in infant nutrition products. While the quick response and the voluntary recall underline the company's commitment to consumer safety, it also serves as a reminder of the inherent risks associated with powdered infant formulas and the need for continuous monitoring and quality control in food products, especially those for the most vulnerable populations.