Overview
- At least 15 infants have been hospitalized since August after exposure to ByHeart formula, with cases reported across 12 states and no deaths to date.
- ByHeart expanded a voluntary recall from two lots to all cans and single‑serve sticks and opened its facilities and products to federal and state investigators.
- California officials reported a preliminary positive for Clostridium botulinum in an opened can fed to a sick infant, while no unopened cans have tested positive.
- FDA data show 84 infants have received treatment for botulism since Aug. 1, with 36 reporting formula exposure and more than a third of those having consumed ByHeart.
- Parents are urged to stop using and discard ByHeart formula, monitor infants for symptoms that can take weeks to appear, and seek immediate care if they develop signs of botulism.