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ByHeart Recalls All Powdered Baby Formula Nationwide After 15 Infant Botulism Hospitalizations

FDA calls ByHeart disproportionately represented in an 84‑case investigation.

Overview

  • Health officials report 15 infants in 12 states were hospitalized after consuming ByHeart formula, with no deaths reported.
  • California found botulinum‑type bacteria in an open can linked to a sick infant, while no unopened ByHeart cans have tested positive to date.
  • The company expanded a Nov. 8 two‑lot recall to every ByHeart can and single‑serve stick, instructing families to stop use and discard product.
  • Parents are urged to watch for symptoms for up to 30 days and seek urgent care if they appear, retaining product for testing only if illness develops.
  • ByHeart is testing every batch with an independent lab, granting regulators full site access as FDA inspectors review the Portland canning facility and the powder plant ships from Iowa.