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ByHeart Recalls All Infant Formula as Botulism Cases Hit 23

ByHeart recalled all infant formula nationwide after 13 botulism cases in 10 states, with ongoing FDA investigations to identify contamination sources and ensure safety.

  • On Nov. 11, parents of affected infants demanded earlier botulism cases be counted after ByHeart recalled all products linked to at least 31 babies sickened in 15 states.
  • Laboratory testing found the bacterium causing infant botulism in unopened ByHeart formula, and officials notified the U.S. Centers for Disease Control and Prevention and U.S. Food and Drug Administration earlier this month as the link strengthened in recent weeks.
  • Clinical reports show infant botulism results when spores germinate in the gut, causing symptoms like constipation, poor feeding, and limb weakness, with fewer than 200 U.S. cases annually.
  • Families report hospitalized infants with lingering effects, and Katie Connolly says it `feels like her daughter has been forgotten`; experts urged including earlier ByHeart cases in the outbreak.
  • Investigators say linking earlier cases is difficult because so much time has passed and many parents lack lot numbers or empty cans to test, despite ByHeart accounting for less than 1 percent of the powdered infant formula market and unopened samples testing positive.
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Bloomberg broke the news in United States on Saturday, November 8, 2025.
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