January 10, 2024
Products produced during the same finished product campaign as the U.S.-recalled product were distributed in at least the following countries: Argentina, Belgium, Belize, Canada, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Ireland, Israel, Jamaica, Mexico, Nicaragua, Peru, Poland, Spain, United Kingdom, and Venezuela. Reckitt/Mead Johnson Nutrition has indicated to FDA that the company has already contacted the regulatory authorities in each of the countries to determine the proper disposition of these products.
December 31, 2023
Today, the U.S. Food and Drug Administration (FDA) is alerting parents, caregivers, and health care providers that Reckitt/Mead Johnson Nutrition has voluntarily recalled certain Nutramigen Hypoallergenic Infant Formula Powder products due to possible Cronobacter sakazakii contamination. No illnesses have been reported to date in connection with this recall, and it is likely most of the product that was distributed in the U.S. has already been consumed.
Consumers who have Nutramigen Hypoallergenic Infant Formula Powder with batch codes below should 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 1 Jan 2025.
Nutramigen is a hypoallergenic infant formula that is used by infants with allergies to cow’s milk. Although this product is a specialty infant formula, there are substitute infant formulas available. If the infant formula your 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, and the agency has been in communication with other manufacturers to request their assistance in ensuring a robust supply of hypoallergenic product.
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 important 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, encourage caregivers to take steps to prepare powdered infant formula as safely as possible.
The Israeli Ministry of Health notified the FDA on Dec. 14 that Nutramigen Hypoallergenic Powdered Infant Formula produced at the Mead Johnson Nutrition Zeeland, Michigan, facility, and exported from the U.S., had initially tested positive for Cronobacter species. The product was tested at the Israeli border during routine sampling. The FDA did not have sufficient information based on this initial test alone to warrant a product action and immediately took additional investigative steps.In consultation with the FDA, Israel initiated whole genome sequencing (WGS) 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.
The FDA immediately commenced a for-cause inspection at Reckitt/Mead Johnson Nutrition's Zeeland facility on Dec. 18 that included collecting environmental samples as well as testing additional samples of finished product from the same batch of Nutramigen infant formula powder tested by Israel. 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.
On Dec. 28, the FDA received the WGS results from Israeli health officials, which confirmed a finding of Cronobacter sakazakii. The FDA immediately contacted Mead Johnson Nutrition and recommended a recall.
On Dec. 29, Reckitt/Mead Johnson Nutrition agreed to initiate a voluntary recall of 675,030 cans of Nutramigen powdered infant formula distributed to the United States. Reckitt/Mead Johnson Nutrition manufactured additional products during this finished product campaign and distributed them outside of the U.S. Reckitt/Mead Johnson Nutrition will be contacting the regulatory authorities in each of those countries to determine the proper disposition of those products.
The FDA has taken numerous steps to enhance the safety of powdered infant formula through the development of a Cronobacter prevention strategy, enhanced inspectional activities, increased engagement with the infant formula industry, and by pursuing regulatory action when appropriate. The agency also sent a letter to manufacturers, packers, distributors, exporters, importers, and retailers involved in the manufacturing and distribution of powdered infant formula to share current safety information and call on the industry to take prompt action to improve processes and programs for the protection of our most vulnerable population.
The agency remains committed to helping ensure an adequate supply of infant formula and giving consumers the utmost confidence that infant formula available in the U.S. is safe and nutritious.