Enfamil Nutrition Nutramigen Powder infant formula - recalled due to Cronobacter sakazakii

United States

Reckitt/Mead Johnson Nutrition (MJN), a producer of nutrition products, announced today that it has voluntarily chosen to recall from the U.S. market select batches of Nutramigen Powder, a specialty infant formula for the dietary management of Cows Milk Allergy (CMA) in 12.6 and 19.8 oz cans, 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. No illnesses or adverse consumer reactions have been reported to date. The products were distributed through retail stores nationwide.

Company Announcement All product tested by MJN was confirmed negative for contaminants.
No Nutramigen liquid formulas or any other Reckitt nutrition products are impacted.

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 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.

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 customer should contact us for a total refund.

Company name: Reckitt/Mead Johnson Nutrition
Brand name: Enfamil
Product recalled: Nutramigen Powder infant formula in 12.6 and 19.8oz cans
Reason of the recall: Potential Cronobacter sakazakii contamination
FDA Recall date: December 31, 2023

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/reckittmead-johnson-nutrition-voluntarily-recalls-select-batches-nutramigen-hypoallergenic-infant