Urgent Recall: ByHeart Formula Linked to Infant Botulism in 15 State

As of November 19, 2025, the CDC and FDA have reported 31 confirmed or suspected cases of infant botulism linked to ByHeart Whole Nutrition Infant Formula across 15 states. All affected infants (aged roughly 2 weeks to 6 months) were hospitalized and treated with BabyBIG® (an antitoxin), with no deaths reported so far. Cases date back to August 2025, and symptoms can appear up to 30 days after exposure, so additional illnesses may still emerge.