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ByHeart Recalls All Powdered Formula as Infant Botulism Cases Reach 31 Across 15 States

Investigators are testing unopened cans to pinpoint the source through ongoing plant inspections.

Overview

  • Federal officials report 31 hospitalized infants since Aug. 9 across 15 states with no deaths, and all received BabyBIG treatment.
  • ByHeart expanded its voluntary recall to all cans and single-serve packs sold nationwide and online, with some product shipped outside the U.S.
  • California confirmed C. botulinum in an opened can fed to a sick infant, and ByHeart says its own testing also detected the bacterium.
  • The FDA is inspecting ByHeart facilities in Allerton, Iowa and Portland, Oregon, and results from unopened-product testing are pending.
  • Recalled formula has been found on shelves in multiple states, and authorities urge caregivers to stop use, label containers “DO NOT USE,” retain them for potential testing, and note California’s public hotline at 833-398-2022.