Overview
- Federal officials say 23 infants in 13 U.S. states have been hospitalized since August after consuming ByHeart powdered formula, prompting a nationwide recall of all unexpired products.
- California testing detected Clostridium botulinum in an opened can used by one sick infant, while no unopened cans have tested positive as FDA and CDC investigations continue.
- ByHeart’s Open Hearted Initiative donated nearly 24,000 cans through 23 partner groups, and some nonprofits report uncertainty about notifying families; PDX Diaper Bank received 400 cans and had already distributed 312.
- All affected infants have received BabyBIG, the only infant botulism antitoxin, and officials warn symptoms may appear up to 30 days after exposure, with no deaths reported.
- The FDA advises caregivers to stop using ByHeart formula and check lot numbers for refunds, no other brands are linked to the outbreak, and Canada’s food regulator issued a parallel do‑not‑consume warning.