Note: Single-source report; awaiting corroboration.
The Centers for Disease Control and Prevention (CDC) has expanded its investigation of infant botulism cases linked to ByHeart infant formula, now including 51 affected infants from 19 states dating back to December 2023. All hospitalized infants have been treated with BabyBIG®, and no deaths have been reported.
Infant botulism occurs when Clostridium botulinum spores ingested by infants grow in the gut and produce toxins. Symptoms often begin with constipation and progress to difficulty feeding, a weak or altered cry, and loss of head control. CDC laboratories confirmed the presence of botulism spores in samples of ByHeart formula collected from the homes of affected infants, indicating product contamination.
Initial notification came on November 7, 2025, when the California Department of Public Health's Infant Botulism Treatment and Prevention Program reported a rise in infant botulism cases associated with ByHeart formula. The CDC and the Food and Drug Administration promptly contacted ByHeart to remove affected lots from the market. By November 8, the CDC advised parents nationwide to stop using two lots of ByHeart formula, expanding this advisory to all ByHeart infant formulas by November 11.
The CDC highlighted this investigation as an example of its rapid response to emerging public health threats. Parents are urged to stop using any ByHeart Whole Nutrition infant formula immediately due to the contamination risk.