Overview
- ByHeart has recalled all powdered infant formula nationwide while FDA, CDC and state agencies inspect facilities and test products to pinpoint the contamination source.
- As of Nov. 14, officials report 23 infants in 13 states with suspected or confirmed botulism after consuming ByHeart formula; all were hospitalized and treated with BabyBIG, and no deaths have been reported.
- The FDA confirmed the botulism organism in at least one ByHeart container, strengthening the epidemiologic link first flagged by California’s Infant Botulism Treatment and Prevention Program.
- State health departments are urging caregivers to stop using ByHeart formula, document lot numbers, keep containers for about 30 days, clean contacted items, and monitor infants since symptoms can appear weeks after exposure.
- Families in Arizona and Kentucky have filed lawsuits alleging negligence and defective product, with attorneys citing significant medical costs and additional cases potentially forthcoming as the investigation continues.