Infant Formula Recalled Due to Harmful Bacteria
Reckitt/Mead Johnson Nutrition, a producer of nutrition products, is conducting a nationwide recall of select batches of Nutramigen Powder, a specialty infant formula for the dietary management of cows' milk allergy in 12.6- and 19.8-ounce cans. The recall comes after Israeli health authorities confirmed on Dec. 14 that a type of bacteria called Cronobacter sakazakii was found in cans that were being imported into Israel from the United States.
However, the U.S. Food and Drug Administration (FDA) did not have sufficient information based on this initial test alone to warrant a product action, so in consultation with the FDA, Israel initiated whole genome sequencing (WGS) on the sample obtained from the infant formula to confirm the initial findings.
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Meanwhile, the U.S. FDA conducted an inspection of Mead Johnson Nutrition's Zeeland, Mich., facility 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.
The recalled Nutramigen products were manufactured in June 2023 and distributed primarily in June, July and August 2023 to retail stores nationwide. Recalled products contain the following batch codes:
- ZL3FHG (12.6-ouncecans)
- ZL3FMH (12.6-ounce cans)
- ZL3FPE (12.6-ounce cans)
- ZL3FQD (12.6-ounce cans)
- ZL3FRW (19.8-ounce cans)
- ZL3FXJ (12.6-ounce cans)
The products have a UPC code of 300871239418 or 300871239456 and a “Use By Date” of “1 Jan 2025.”
Based on the limited availability of the remaining stock, it's believed that much, if not all, of the products recalled in the United States have been consumed. No reports of illnesses have been reported.
Cronobacter bacteria can cause severe, life-threatening infections (sepsis) or meningitis (an inflammation of the membranes that protect the brain and spine). Symptoms of sepsis and meningitis may include poor feeding, irritability, temperature changes, jaundice (yellow skin and whites of the eyes), grunting breaths and abnormal movements. Cronobacter infection may also cause bowel damage and may spread through the blood to other parts of the body.
The FDA doesn't 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.
In 2022, the United States experienced a major baby formula shortage due to supply chain issues and Abbott Nutrition recalling its products – also due to concerns about Cronobacter sakazakii contamination.
