CNN –
On Sunday, the U.S. Food and Drug Administration warned consumers about possible bacterial contamination in Reckitt/Mead Johnson's Nutramigen hypoallergenic infant formula products. The special formula is a hypoallergenic infant formula used by infants with cow's milk allergies.
Manufacturers voluntarily recalled 675,030 doses of the formula on December 29 after Israel's Ministry of Health notified the FDA that the exported formula tested positive for Cronobacter sakazakii. The Cronobacter bacteria can cause rare but potentially fatal infections in newborns. It is present in the environment but can also contaminate powdered infant formula. The recalled cans of formula were distributed in the United States and additional products were exported.
The agency notes that no illnesses have been reported to date and that most of the product distributed in the U.S. has likely already been consumed.
“All products in question underwent extensive testing,” the company said in its press release, “and tested negative for bacteria.”
The FDA says consumers using hypoallergenic Nutramigen infant formula powder with the lot codes listed below should not use the product and throw away the infant formula immediately. Consumers can contact Reckitt/Mead Johnson Nutrition for a refund.
• ZL3FHG (12.6-ounce cans)
• 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 an “expiration date” of January 1, 2025.
Although this product is a specialty infant formula, substitute infant formulas are available and the agency recommends users work with their health care providers to find a replacement.
Cronobacter has been linked to the 2022 nationwide formula shortage, but the agency does not expect this voluntary recall to have a significant impact on formula supplies.
On December 14, the Israeli Ministry of Health notified the FDA that products tested at the Israeli border as part of routine sampling tested positive for the bacteria. In consultation with the FDA, Israel initiated whole-genome sequencing of the products and confirmed the presence of the bacteria on December 28.
On December 18, the FDA immediately began a precautionary inspection at Reckitt/Mead Johnson Nutrition's Zeeland facility, which included testing of both formula samples and environmental samples. The FDA inspection is currently ongoing, but all tests to date have been negative for Cronobacter.