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Federal and state health officials are currently investigating a multistate outbreak of infant botulism, a rare but serious illness, linked to a specific brand of baby food. The investigation, led by the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA), has identified ByHeart Whole Nutrition Infant Formula as the likely source of contamination.
As of mid-November 2025, a total of 15 infants across 12 states have been reported with suspected or confirmed cases of infant botulism. According to the FDA, the onset of these illnesses ranged from August 9 to November 10, 2025. In response to the outbreak, ByHeart has issued a nationwide voluntary recall of all its infant formula products. The recall includes all unexpired lots of both formula cans and single-serve 'anywhere pack' sticks. The FDA noted that these products constitute approximately 1% of the U.S. infant formula market and that the recall is not expected to cause a widespread supply shortage.
Infant botulism occurs when a baby ingests spores of Clostridium botulinum bacteria, which then grow in the intestines and release a harmful neurotoxin. The CDC's public health alert warns parents that initial symptoms often include constipation, followed by more severe signs such as poor feeding, a weak or altered cry, loss of head control, and difficulty swallowing. These symptoms can progress to muscle paralysis and respiratory failure, making it a medical emergency that requires immediate hospitalization.
Health agencies are urging parents and caregivers to immediately stop using and discard any ByHeart infant formula they may have. Authorities advise that if an infant has consumed the recalled product and shows any symptoms of botulism, they should be taken to a healthcare provider without delay. The scope of the botulism outbreak continues to be monitored, with health departments in affected states, including North Carolina and Michigan, issuing their own alerts to ensure the recalled product is removed from homes and store shelves.
