More than 675,000 cans of specialty baby formula are being recalled due to possible bacterial contamination, the manufacturer announced on Saturday.
Reckitt and Mead Johnson Nutrition, which makes Enfamil and Nutramigen, said it is voluntarily recalling cans of its Nutramigen Hypoallergenic Formula Powder, a kind of formula made for babies who are allergic to cow’s milk. The recall comes after Israeli health authorities found a type of bacteria called Cronobacter sakazakii in cans being imported into Israel from the United States, CBS News reported.
“When we were alerted in December to a potential for cross-contamination in product samples outside the U.S., both Reckitt/Mead Johnson and the US FDA tested samples from the batch in question and all tests came back negative,” a Reckitt and Mead Johnson Nutrition spokesperson told ABC News in a statement.
The statement continued:
However, Reckitt/Mead Johnson understands the incredible responsibility we have in providing what is often the sole nutrition for infants, and there can be no short cuts for this vulnerable population – therefore, we chose to recall select batches of Nutramigen out of an abundance of caution.
Parents should be reassured that they can continue to feed their infants with Reckitt/Mead Johnson Nutrition products, including other Nutramigen powder formula batches, with confidence.
The recall applies to 675,030 12.6 oz and 19.8 oz containers that were manufactured in June 2023 and distributed across the United States primarily in June, July, and August, according to the FDA. The cans were produced at a Mead Johnson plant in Zeeland, Michigan, which is now facing an inspection as a result of the possible contamination, CBS News reported.
The following recalled product batch codes and can sizes associated with each batch were distributed in the United States:
- 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)
- ZL3FXJ (12.6 oz cans)
“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 FDA said in its Dec. 31 announcement.
Cronobacter sakazakii “can cause severe, life-threatening infections (sepsis) or meningitis (an inflammation of the membranes that protect the brain and spine),” the company noted in its recall announcement.
“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 announcement continues.
According to CBS News, Reckitt’s Mead Johnson was one of three baby formula manufacturers to receive warning letters from the FDA in August.
“Among the issues scrutinized by the agency were detections of Cronobacter in ‘high and critical hygiene zones’ of the Zeeland plant. FDA records show another inspection of the same facility had ended just weeks before,” according to the report. “After that visit, the FDA cited the factory for falling short on precautions needed to ensure that its product did not become contaminated by ‘microorganisms in the formula or in the processing environment.'”
