Overview
- Federal and state agencies are investigating a multistate infant botulism outbreak, with the FDA noting ByHeart is disproportionately represented despite holding about 1% of U.S. formula sales.
- Tuesday’s expansion covers all ByHeart Whole Nutrition Infant Formula cans and Anywhere Pack single‑serve sticks sold online and at major retailers, and consumers are urged to stop use and discard products.
- California reported preliminary detection of Clostridium botulinum in an opened can linked to a sick infant, while testing of unopened cans and sticks has not found spores or toxin.
- All 15 affected infants, ages 16 to 157 days, were hospitalized and treated with BabyBIG, and no deaths have been reported, according to CDC and FDA updates.
- ByHeart says it has engaged an independent lab to test every batch, granted regulators full access to facilities from Iowa production to Portland canning, and expects additional testing results in the coming weeks.