ByHeart infant formula maker recalls all products amid botulism outbreak

Infant formula maker ByHeart is recalling all of its products amid an outbreak of botulism likely tied to its organic powdered formula.

Baby formula maker ByHeart is recalling all of its products amid an outbreak of infant botulism likely tied to its powdered formula.

Since August, 15 cases have been reported across 12 states, nearly all among babies between 16 days and around 5 months old, according to the Food and Drug Administration.

After the FDA announced Saturday that it was investigating the outbreak and its link to ByHeart's organic Whole Nutrition Infant Formula, the company recalled two lots of the product. ByHeart then expanded the recall Tuesday to include all batches of the formula, both in cans and "anywhere packs" — small, sealed pouches.

"The safety and well‑being of every infant who uses our formula is, and always will be, our highest priority,” ByHeart's co-founder and president, Mia Funt, said in a statement. “This nationwide recall reflects our commitment to protecting babies and giving families clear, actionable information. Alongside this recall, we are conducting a comprehensive investigation to do our part to get the answers parents expect and deserve.”

Infant botulism arises when babies ingest food contaminated with Clostridium botulinum bacteria, which produce a toxin that affects the body's nervous system. The infection can cause constipation, poor feeding, loss of head control and difficulty swallowing. Untreated, it can ultimately lead to paralysis and death, according to the Centers for Disease Control and Prevention. No deaths have been reported in the current outbreak.