Overview
- Thirteen infants in 10 states were hospitalized after caregivers reported feeding ByHeart Whole Nutrition Infant Formula, and no deaths have been reported.
- The voluntary recall covers lots 206VABP/251261P2 and 206VABP/251131P2 with a use-by date of Dec. 1, 2026.
- The FDA says a direct causal link to the formula has not been confirmed, noting infant botulism from formula is historically rare.
- State and federal labs are analyzing collected product and conducting epidemiologic tracing, with results expected in the coming weeks.
- Caregivers are urged to record lot codes, discard recalled cans, clean items that contacted the powder, and seek immediate care if infants show symptoms; the product accounts for under 1% of U.S. formula sales.