Overview
- CDC widened its case definition to include any infant exposed to ByHeart formula since its 2022 launch, adding 10 earlier cases to reach 51 across 19 states.
- FDA said it cannot rule out contamination across all ByHeart products while the most recent reported illness occurred on Dec. 1.
- Company and independent testing detected Clostridium botulinum in 5 of 36 samples from three lots of powdered formula.
- All identified infants were hospitalized with suspected or confirmed botulism, no deaths have been reported, and ages ranged from 16 to 264 days.
- ByHeart recalled all cans and single‑serve packs on Nov. 11; officials advise caregivers to stop use, record lot details, retain leftover product for possible testing, and seek care if symptoms appear.