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ByHeart Orders Nationwide Recall of All Baby Formula as Botulism Probe Widens

Regulators say the brand accounts for a disproportionate share of recent infant botulism cases despite representing about 1% of U.S. formula sales.

Overview

  • The company expanded a weekend, lot-specific action into a voluntary recall of every ByHeart powdered product sold in the United States, including Whole Nutrition Infant Formula and Anywhere Pack sachets.
  • State and federal officials report at least 15 infants in 12 states were hospitalized after consuming ByHeart formula, and no deaths have been reported.
  • The FDA is investigating 84 infant botulism cases detected since August, with 36 involving formula exposure and a notable share linked to ByHeart.
  • California health authorities found the bacterial type associated with the outbreak in a sample from a ByHeart can given to a sick infant, while the company says no unopened cans have tested positive.
  • FDA inspectors visited ByHeart’s Portland, Oregon canning site, and the company is testing every lot with independent labs and instructing families to stop using and discard recalled product.