Overview
- At least 31 infants in 15 states have been hospitalized since August after drinking ByHeart formula, all treated with BabyBIG, with no deaths reported.
- The FDA and CDC are investigating, with unopened and leftover product testing under way and inspection results from ByHeart’s Iowa and Oregon plants pending.
- California officials detected botulinum neurotoxin and confirmed C. botulinum in an opened can linked to a sick infant, and ByHeart says its own testing identified the bacterium.
- Despite a nationwide recall of all unexpired cans and single‑serve packs, investigators report recalled product still on store shelves in multiple states and removal efforts continue.
- Families have filed lawsuits alleging a defective product, and health guidance urges caregivers to stop using the formula, label containers “DO NOT USE,” retain them for possible testing, and watch for symptoms that can appear weeks after exposure.