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ByHeart Recalls All Powdered Infant Formula as Botulism Outbreak Reaches 23 Hospitalizations

Federal inspectors are probing production sites to determine how contamination occurred.

Overview

  • Federal officials report 23 infants in 13 states have been hospitalized since August, all after consuming ByHeart powdered formula, with no deaths to date.
  • Laboratory testing in California detected Clostridium botulinum in an opened can used to feed a sick infant, while no unopened cans have tested positive.
  • ByHeart broadened a limited recall to all batches of its Whole Nutrition Infant Formula cans and Anywhere Pack nationwide, and says it is cooperating with FDA and CDC investigators.
  • All affected infants received the BabyBIG antitoxin, and health authorities urge caregivers to discard the product, monitor for symptoms that can appear weeks after exposure, and seek immediate medical care.
  • Parents in at least two cases have filed federal lawsuits, charities report distributing donated ByHeart cans to vulnerable families, and Canadian regulators warned against specific sizes sold online.