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ByHeart Recalls All Formula After Botulism in 31 Infants

Published 25 November 2025

At least 31 infants across 15 states have been hospitalized with botulism linked to ByHeart Whole Nutrition Infant Formula, prompting the company to issue a nationwide recall of all its products and admit that independent tests detected Clostridium botulinum spores in some samples. The outbreak, which began emerging in August, marks the first known instance of botulism tied to powdered infant formula in the United States, according to health officials.

The Food and Drug Administration and Centers for Disease Control and Prevention reported the cases as of Thursday, with Texas recording the highest number at six, followed by California with four. Arizona and Oregon each have three confirmed illnesses, while North Carolina, Washington, Minnesota and Illinois report two apiece. Single cases have been identified in Kentucky, Pennsylvania, Idaho, Maine, Michigan, New Jersey and Rhode Island. All affected infants required hospitalization, but no deaths have occurred. Symptoms, which can appear weeks after exposure, include constipation, excessive drooling, droopy eyelids, poor feeding, difficulty swallowing, loss of head control and reduced facial expressiveness. The bacteria produce...

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