A popular baby formula brand is recalling several batches of product amid a nationwide outbreak of infant botulism.

ByHeart issued a voluntary recall of two batches of formula on Nov. 8 after receiving a notice from the U.S. Food and Drug Administration about an ongoing investigation into the recent outbreak.

Per the FDA, the company was notified Nov. 7 about an estimated 83 cases of infant botulism that have been reported across the United States since August 2025, with 13 of those infants receiving formula from ByHeart at some point.

In a statement on its website , ByHeart clarified, “It’s important to know that the FDA has never found a direct link between infant formula and infant botulism, and no related toxins have been found in any ByHeart product.”

“Still, we decided to tak

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