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Botulism Spreads: All ByHeart Formula Linked to Sickness
11 Dec
Summary
- Infant botulism outbreak now affects over 50 babies across 19 states.
- Federal investigators cannot rule out contamination in all ByHeart formula.
- ByHeart formula, accounting for 1% of the market, was recalled Nov. 11.
Federal health officials have broadened an infant botulism outbreak investigation concerning ByHeart baby formula. The U.S. Food and Drug Administration now states that contamination cannot be ruled out in any ByHeart formula produced since March 2022. This expansion increases the total number of affected infants to at least 51 across 19 states, with the latest reported illness on December 1.
ByHeart, a New York-based company, accounts for approximately 1% of the U.S. infant formula market. The company initiated a recall of all its products sold in the United States on November 11. While the outbreak was announced on November 8, the expanded definition includes cases dating back to December 2023, previously totaling 39 suspected or confirmed cases.
Infant botulism is a rare but serious illness caused by bacteria producing a toxin that affects the nervous system. Symptoms can include feeding difficulties, muscle weakness, and breathing problems. The sole treatment is an IV medication called BabyBIG. Families of affected infants have filed lawsuits alleging negligence and defective product claims against ByHeart.
