Reckitt/Mead Johnson Nutrition has voluntarily recalled specific batches of Nutramigen Hypoallergenic Infant Formula Powder due to potential contamination with Cronobacter sakazakii. The U.S. Food and Drug Administration (FDA) is alerting parents, caregivers, and health care providers about this recall.

Product Information:

• Nutramigen Hypoallergenic Infant Formula Powder with batch codes ZL3FHG, ZL3FMH, ZL3FPE, ZL3FQD, ZL3FRW, and ZL3FXJ.
• Affected products come in 12.6 oz and 19.8 oz cans, with UPC Codes 300871239418 or 300871239456 and a “Use By Date” of 1 Jan 2025.

Safety Measures:

• Consumers possessing recalled products are advised to discontinue use immediately, dispose of the formula, or contact Reckitt/Mead Johnson Nutrition for a refund.
• No illnesses have been reported to date, and it is believed that most distributed products have already been consumed.

Background and Investigation:

• The Israeli Ministry of Health initially detected Cronobacter species in Nutramigen Hypoallergenic Powdered Infant Formula produced at the Mead Johnson Nutrition Zeeland, Michigan, facility.
• The FDA, in collaboration with Israeli health officials, confirmed the presence of Cronobacter sakazakii through whole genome sequencing (WGS) on Dec. 28.

Recall Details:

• Reckitt/Mead Johnson Nutrition initiated a voluntary recall of 675,030 cans of Nutramigen powdered infant formula distributed in the U.S.
• Additional products from the same finished product campaign were distributed outside the U.S., and regulatory authorities in those countries will be contacted to determine proper disposition.

FDA Actions:

• The FDA undertook a for-cause inspection at the Zeeland facility, including environmental and product testing, which, as of now, has shown negative results for Cronobacter.
• The agency has implemented measures to enhance the safety of powdered infant formula, including a Cronobacter prevention strategy, increased inspectional activities, and engagement with the industry.

Consumer Guidance:

• Parents and caregivers using Nutramigen should seek suitable substitutes after consulting their child’s health care provider.
• The FDA assures that this recall is not expected to significantly impact the U.S. supply and availability of powdered infant formulas.
• The FDA has issued a letter to manufacturers, packers, distributors, exporters, importers, and retailers involved in powdered infant formula, urging prompt action to improve safety measures.

Source: https://www.fda.gov/food/cfsan-constituent-updates/reckittmead-johnson-nutrition-voluntarily-recalls-certain-nutramigen-hypoallergenic-powdered-infant