The Food and Drug Administration said it is investigating four reports of infants who were hospitalized after consuming the formula, including one who died.
The agency said one of the cases involved salmonella and three involved Cronobacter sakazakiim, a rare but dangerous germ that can cause blood infections and other serious complications.
The recall affects certain lots of Similac, Alimentum and EleCare with expiration dates of April 1, 2022, or later. The product was distributed throughout the U.S. and overseas, the company said in a statement. “We’re working diligently with our partners to investigate complaints related to these products, which we recognize include infant formula produced at this facility, while we work to resolve this safety concern as quickly as possible,” said FDA Deputy Commissioner Frank Yiannas.
Abbott could not specify how many units the recall includes, but brands like Similac are among the best-selling formulas in the U.S. and overseas.
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