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ByHeart Recalls All U.S. Infant Formula as Botulism Investigation Expands

Regulators say the small brand is overrepresented in an ongoing investigation into infant botulism.

El sello de la Administración de Alimentos y Medicamentos de EEUU (FDA, por sus siglas en inglés) se ve en el Auditorio del Edificio Hubert Humphrey, en Washington, el 22 de abril de 2025. (AP Foto/José Luis Magaña, Archivo)
Según el director médico de ByHeart, Dr. Devon Kuehn, la empresa comercializa alrededor de 200 mil latas al mes tanto en línea como en tiendas como Target, Walmart, Albertsons y Whole Foods. Foto: Especial.
Esta imagen sin fecha proporcionada por ByHeart muestra un producto de fórmula bebé de ByHeart. (ByHeart vía AP)
Lo ideal es que no se duerman en brazos, ni en el pecho, ni tomando la mamadera, sino unos instantes después de haber hecho cualquiera de estas cosas.

Overview

  • The voluntary recall covers all ByHeart Whole Nutrition Infant Formula powder and the Anywhere Pack sachets sold nationwide.
  • At least 15 infants in 12 states have been hospitalized after exposure linked to ByHeart formula, all received BabyBIG treatment, and no deaths have been reported.
  • The FDA is investigating 84 infant botulism cases detected since August; 36 involved formula and more than a third used ByHeart despite its roughly 1% U.S. market share.
  • California officials found the botulism‑causing bacteria in an opened can tied to a case, while no unopened ByHeart products have tested positive and more testing is underway.
  • ByHeart says it is testing every lot with independent laboratories and giving the FDA full access to its facilities, and families are urged to discard the product and watch for symptoms.