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FDA recalls Nutramigen baby formula due to possibile contamination

PARSIPPANY, N.J.—Reckitt/Mead Johnson Nutrition has announced a voluntary recall of select batches of Nutramigen Powder.  The specialty infant formula for the dietary management of Cows Milk Allergy (CMA) in 12.6 and 19.8 oz cans is being recalled due to a possibility of contamination with Cronobacter sakazakii in product sampled outside the U.S. All product in question went through extensive testing by MJN and tested negative for the bacteria.

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.

Nutramigen in 12.6 and 19.8 oz containers was manufactured in June 2023 and distributed primarily in June, July, and August 2023. 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. There are no reports of illnesses or adverse events to date. The products were distributed through retail stores nationwide. The batches in question can be identified by the batch code on the bottom of the can.

The following recalled product batch codes and can size associated with each batch were distributed in the U.S.:

  • 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); and
  • ZL3FXJ (12.6 oz cans).

The products have a UPC Code of 300871239418 or 300871239456 and “Use By Date” of “1 Jan 2025”.

No other U.S. distributed Nutramigen batches or other Reckitt products are impacted.

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.

Parents with questions should consult with their pediatrician, call 866-534-9986 24/7, or email [email protected].

Consumers who purchased Nutramigen should check the bottom of the can to identify whether the batch number is affected. Product with the batch codes listed above should be disposed of.

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