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As of December 3, 2025, the Food and Drug Administration, Centers for Disease Control and Prevention, and several state health authorities have reported a total of 39 suspected or confirmed cases of infant botulism across 18 states, attributed to ByHeart baby formula sold in retail stores. Preliminary testing in California found multiple lots of formula contaminated with Clostridium botulinum type A. The 39 infants have been hospitalized, and no deaths have been reported. Onset of illness ranged from August 9 to November 19, 2025. In response, manufacturer ByHeart has expanded its nationwide recall.
Mind the shopping cart: What’s concerning is that the federal agencies report some of the recalled formula is still being found on store shelves in spite of the recall notifications that have been posted since November 11, 2025. The highest case counts have occurred in Texas, California, Arizona, and Oregon, although East Coast and Northwest states are tracking cases as well. Clinicians should maintain high suspicion for infant botulism among infants presenting with feeding difficulty, hypotonia, swallowing/respiratory compromise, the agencies say. Suspected cases should be reported to public-health authorities immediately.