Reckitt Benckiser Group's Mead Johnson Nutrition (MJN) is voluntarily recalling select batches of Nutramigen Powder from the U.S. market due to a possibility of contamination with Cronobacter sakazakii bacteria in product sampled outside the United States, the Food and Drug Administration said on Sunday.
Nutramigen Powder, a specialty infant formula for the dietary management of Cows Milk Allergy (CMA) in 12.6- and 19.8-ounce cans, went through extensive testing by MJN and tested negative for the bacteria, the FDA said.
The Nutramigen containers were manufactured in June 2023 and distributed primarily in June, July and August, the FDA said.
"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," the FDA said, adding there are no reports of illnesses or adverse events to date.
All the recalled products have the "Use By Date" of "1 Jan 2025,", Reckitt said, asking customers to dispose of the products if they belong to the recalled batches.
"No other U.S.-distributed Nutramigen batches or other Reckitt products are impacted," Reckitt said.
Cronobacter bacteria can cause severe, life-threatening infections or meningitis. The infection may also cause bowel damage and may spread through the blood to other parts of the body.