Overview
- Federal and state agencies are probing 13 hospitalizations linked to ByHeart Whole Nutrition powdered formula, with cases reported since August in 10 states and no deaths to date.
- ByHeart voluntarily recalled two lots — 206VABP/251261P2 and 206VABP/251131P2 — both marked “Use by 01 Dec 2026.”
- The FDA and CDC say no definitive nationwide link has been established to infant formula, and ByHeart reports no confirmed positive tests in its products.
- California’s public health lab reported preliminary evidence of C. botulinum in a sample, while confirmatory testing and epidemiologic investigations continue.
- Parents are urged to stop using and discard or return recalled cans, clean surfaces that contacted the product, seek care for symptoms, and clinicians are advised to report suspected cases and consider BabyBIG treatment.