Overview
- Regulators confirm 31 hospitalized cases across 15 states in infants aged roughly two weeks to six months, with the most recent illness reported on November 13 and no deaths to date.
- ByHeart broadened its voluntary recall to every lot of its Whole Nutrition powdered formula and single-serve sachets and urged caregivers to stop using the product immediately.
- Independent labs cited by the company detected Clostridium botulinum in some samples and California officials found the bacterium in an opened can, while ByHeart says unopened cans tested negative and the FDA cautions negatives do not rule out contamination.
- The FDA inspected production facilities in Iowa and Oregon with results pending, and caregivers were advised to label containers “DO NOT USE” or “NO USAR” and keep them for possible analysis.
- State inspections found recalled product still for sale in a small number of stores before removal, and parents of affected infants have filed federal lawsuits alleging negligence.