Specialty Powdered Infant Formula Recalled from Shelves

WASHINGTON, D.C. – A specialty powdered infant formula has been pulled from shelves after concerns of contamination. Pennsylvania Senator Bob Casey (D- PA) recently penned a letter to the company Reckitt/Mead Johnson demanding answers about the recall. 

“These families need answers and that’s why I’m going to continue to press for these answers,” said Sen. Casey. Casey recently sent a letter to formula producer Reckitt/Mead Johnson looking for answers regarding a recent recall of hundreds of thousands of cans of Nutramigen powder. It’s a specialty infant formula for babies with allergies to cow’s milk. The company announced a voluntary recall last month after the Israeli Ministry of Health notified officials in December that batches of the formula exported from the US had initially tested positive for a bacteria that is known to cause issues like sepsis or meningitis. The recall comes two years after a major formula shortage had many families worried about keeping their babies fed. 

“In some ways I was thinking here we go again because two years ago we had an even larger challenge,” said Sen. Casey.  

Casey led the charge in the Senate to resolve the 2022 infant formula shortage and to prevent future shortages, including passing legislation that included provisions to address another infant formula shortage crisis.  

With this recall, the FDA does not believe it will have a major impact on US supply and availability for powdered infant formulas. The agency adds there are substitute infant formulas available. According to the FDA, they inspected the company’s Michigan facility mid-December including testing additional samples of the product from the same batch. While their investigation is still ongoing, all testing for the bacteria so far has been negative. 

Reckitt/Mead Johnson also sent us a statement: 

Reckitt/MJN manufactured a batch of Nutramigen Hypoallergenic Infant Formula Powder in the summer of 2023 for distribution in Israel.    In December 2023, The Israeli Ministry of Health notified the FDA that during routine testing at the border, a single test they conducted on the Nutramigen batch came back positive for Cronobacter species. The FDA then tested samples of finished product from the same batch of Nutramigen sent to Israel, and all tests came back negative for Cronobacter.  The FDA also conducted an inspection at the facility where the batch was produced, including collecting environmental samples, and all testes came back negative.

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.  Given the timeframe and limited batches this voluntary recall includes, it is believed that much, if not all, of the select product has been consumed.  We do not expect this precautionary measure to have an impact on current Nutramigen production, and it has no impact on any other Reckitt/Mead Johnson formula or nutrition products. All facilities remain fully operational and Reckitt/ Mead Johnson remains committed to providing high quality and safe infant formula.  Parents should be reassured that they can continue to feed their infants with Reckitt/Mead Johnson Nutrition products with confidence.

“For these families this is not a policy debate,” said Sen. Casey. “This is about fundamental peace of mind whether or not they’ll have a peace of mind.” 

According to the FDA there have been no known illnesses in connection to this recall.