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FDA Says Infant Botulism Cases Reach 37 in ByHeart Formula Outbreak

Company tests indicate possible contamination across all lots.

Overview

  • ByHeart reported that 5 of 36 tested samples contained Clostridium botulinum Type A and said it cannot rule out contamination across every product lot.
  • The FDA now reports 37 suspected or confirmed infant illnesses since August across 17 states, with all babies hospitalized and no deaths reported.
  • A nationwide recall of all ByHeart powdered formula remains in effect, yet the FDA says recalled cans have still been found at major retailers.
  • Inspectors are reviewing ByHeart facilities in Iowa and Oregon and testing opened and unopened cans after California officials detected the bacteria in a can linked to an illness.
  • Families have filed lawsuits alleging harm from the product, while caregivers are urged to stop use, monitor for symptoms for up to 30 days, and request refunds for online purchases made on or after Aug. 1.