ByHeart Botulism Outbreak Grows as CDC Finds Earlier Cases

An outbreak of infant botulism linked to ByHeart’s baby formula is much wider than initially thought, potentially dating back two years, US health agencies said Wednesday.

An investigation found 10 new cases of baby botulism from December 2023 through July 2025, the Food and Drug Administration said. The total outbreak now includes 51 infants with confirmed or suspected botulism across 19 states that consumed formula from ByHeart, the agency said.