Overview
- ByHeart expanded a voluntary recall from two lots to all Whole Nutrition Infant Formula cans and Anywhere Pack sticks sold online and in major retailers.
- At least 15 infants in 12 states were hospitalized with suspected or confirmed infant botulism after consuming the product, and no deaths have been reported.
- The FDA is probing dozens of infant botulism cases since August and reports that ByHeart accounts for a disproportionate share of exposures despite roughly 1% market share.
- Preliminary testing in California detected Clostridium botulinum in an opened can tied to a sick infant, while no unopened cans have tested positive.
- Parents are urged to stop using and discard ByHeart formula and monitor exposed infants for symptoms over several weeks as labs test product and FDA inspectors review the Portland canning site.