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FDA Says Recalled ByHeart Formula Still on Shelves as Infant Botulism Cases Reach 39 Across 18 States

Health officials urge parents to discard the product pending an investigation into confirmed contamination.

Overview

  • Two infants in Massachusetts are among the 39 hospitalized cases reported since August, and no deaths have been reported.
  • Federal and company testing detected Clostridium botulinum in some ByHeart powdered formula samples tied to the illnesses.
  • Despite a Nov. 11 voluntary recall, the FDA says recalled cans have been found at Walmart, Target, Kroger, Acme and Shaw’s.
  • FDA inspectors visited ByHeart production sites in Allerton, Iowa, and Portland, Oregon, as the probe to pinpoint contamination continues.
  • Affected infants ranged from about 2 weeks to 9 months old with illness onset from Aug. 9 to Nov. 19; families have filed lawsuits, treatment relies on BabyBIG, and officials say ByHeart’s small market share limits supply disruptions.