Reckitt Benckiser Group's Mead Johnson Nutrition (MJN) issued a voluntary recall for certain infant formula products distributed in the U.S. due to concerns that it could be contaminated with potentially dangerous bacteria, according to federal health officials.
The company recalled 675,030 cans of Nutramigen powdered infant formula over concerns that it could be contaminated with cronobacter sakazakii, the Food and Drug Administration (FDA) said in a warning notice posted Sunday.
The Nutramigen product is a hypoallergenic infant formula that is used by infants with allergies to cow’s milk. Even though it is a specialty infant formula, there are substitute infant formulas available, the FDA said.
The Israeli Ministry of Health notified the FDA earlier this month that Nutramigen Hypoallergenic Powdered Infant Formula produced at a Michigan facility and exported from the U.S. had initially tested positive for cronobacter species.
Further testing then confirmed "a finding of Cronobacter sakazakii," which prompted the recall, the FDA said.
To date, there haven't been any illnesses reported in connection to the recalled products. Additionally, the FDA said it's "likely most of the product that was distributed in the U.S. has already been consumed."
However, the pathogen has caused the major formula producers to issue recalls several times over the past year, including Reckitt, which is one of four companies alongside Gerber, Perrigo and Abbott Laboratories that produce 90% of the formula in the U.S.
It is also the same bacteria that caused infections among four infants who consumed powdered formula from Abbott's baby formula plant in Michigan, which was shut down in 2022 due to contamination issues. The temporary halt in operations exacerbated the industry-wide infant formula shortage in the U.S.
Abbott has maintained that its products have not been directly linked to the infections, which involved different bacterial strains.
FILE - Reckitt/Mead Johnson Nutrition's Nutramigen Powder infant formula in 19.8 oz can. (FDA)
The FDA said it does not "expect that this recall will have a major impact on the U.S. supply and availability of powdered infant formulas."
Other manufacturers have also been requested to assist in ensuring there is a robust supply of hypoallergenic product during this time.
The FDA said cronobacter sakazakii is found naturally in the environment that can enter manufacturing facilities and home environments on hands, shoes and other contaminated surfaces.
While infant formula firms are required to test a representative sample of their product for both Cronobacter and Salmonella species, this does not guarantee the product is free of Cronobacter.
Contamination with the bacteria "can occur at very low levels and is not evenly distributed throughout the product, making it difficult to detect," the FDA said.
Additionally, officials warned that "powdered infant formula is not a sterile product and public health agencies, including the FDA, encourage caregivers to take steps to prepare powdered infant formula as safely as possible."