ByHeart is voluntarily recalling two batches of its Whole Nutrition Infant Formula amid a recent outbreak of infant botulism, the company announced.
The recall follows notification from the FDA of an ongoing investigation into approximately 83 cases of infant botulism reported nationwide since August. Thirteen of those infants had consumed ByHeart formula at some point, the company said.
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California health officials said they had "tested a can of powdered infant formula that was fed to an infant with infant botulism. Preliminary results suggest the presence of the bacteria that produce botulinum toxin, consistent with the same toxin reported in the confirmed infant cases."
Infant botulism is a rare but potentially serious illness. Symptoms can include constipation, feeding difficulties, weak muscle tone, drooping eyelids, trouble breathing and, in severe cases, respiratory failure.
The recall affects batch codes 251261P2 and 251131P2, both with a “use by” date of Dec. 1, 2026. They were sold by national retailers including Amazon, Kroger, Walmart, Whole Foods and Target.
