A multistate outbreak of infant botulism linked to ByHeart Whole Nutrition infant formula is being investigated by the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), and state health agencies after 23 infants in 13 states were hospitalized; no deaths have been reported. The company recalled all lots of the product on November 11 2025, and the CDC is urging parents and caregivers to stop using any ByHeart formula, photograph lot numbers, safely store or dispose of leftovers, and watch for symptoms such as poor feeding, loss of head control, or difficulty swallowing. The investigation remains open, and the CDC emphasizes that symptoms may appear several weeks after exposure and immediate medical care and specimen collection may be required.
Infant Botulism Outbreak Linked to Infant Formula, November 2025
