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Reckitt Benckiser Group's Mead Johnson Nutrition (MJN) has issued a voluntary recall of certain infant formula products sold in the United States due to concerns that they may be contaminated with potentially dangerous bacteria, according to federal health officials.
The company recalled 675,030 cans of powdered Nutramigen infant formula because of concerns that they may be contaminated with Cronobacter sakazakii, the Food and Drug Administration (FDA) said in an alert released Sunday.
The Nutramigen product is a hypoallergenic infant formula used by infants with cow's milk allergies. Although it is a specialized infant formula, there are also substitute formulas for infants, according to the FDA.
Israel's Health Ministry told the FDA earlier this month that Nutramigen's powdered hypoallergenic infant formula, manufactured at a facility in Michigan and exported from the United States, initially tested positive for Cronobacter species.
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Further testing then confirmed “a finding of Cronobacter sakazakii,” triggering the recall, the FDA said.
To date, no illnesses have been reported in connection with the recalled products. Additionally, the FDA said that “it is likely that the majority of the product distributed in the United States has already been consumed.”
But the pathogen has caused major formula makers to issue multiple recalls over the past year, including Reckitt, which is one of four companies that makes 90% of the formula in the U.S., along with Gerber, Perrigo and Abbott Laboratories
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They are also the same bacteria that caused infections in four infants who consumed powdered infant formula from Abbott's baby formula plant in Michigan, which closed in 2022 due to contamination issues. The temporary shutdown exacerbated the industry-wide shortage of infant formula in the United States
Abbott has maintained that its products are not directly linked to the infections, which involved various strains of bacteria.
Baby formula is used to nourish babies when breast milk is not possible or is in short supply. (iStock / iStock)
The FDA said it does not expect this recall “to have a major impact on the supply and availability of powdered infant formula in the United States.”
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Other manufacturers have also been asked to help ensure there is an adequate supply of hypoallergenic products during this time.
The FDA said Cronobacter sakazakii occurs naturally in the environment and can enter manufacturing facilities and home environments via hands, shoes and other contaminated surfaces.
While infant formula manufacturers are required to test a representative sample of their product for both Cronobacter and Salmonella species, this is not a guarantee that the product is free of Cronobacter.
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Contamination with the bacteria “may occur in very small amounts and is not uniformly 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 authorities, including the FDA, encourage caregivers to take steps to make powdered infant formula as safe as possible.”