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37 Cases of Infant Botulism Reported in ByHeart Whole Nutrition Formula Recall

The outbreak caused 37 cases since August, with all infants hospitalized after consuming ByHeart formula, prompting a nationwide recall and ongoing FDA investigation.

  • The FDA reported 37 infant botulism cases linked to ByHeart formula since August, with illnesses occurring between Aug. 9 and Nov. 19, and the latest case on Nov. 19.
  • Lab testing shows the bacterium that causes infant botulism in some ByHeart samples, including an open can tested in California; the spores produce toxins in infants' intestines, especially vulnerable due to underdeveloped gut microbiomes, with no prior powdered infant formula outbreaks confirmed by research studies.
  • Affected infants, aged about 2 weeks to about 9 months, were hospitalized after consuming ByHeart powdered formula and some received BabyBIG; symptoms can take up to 30 days to appear, including feeding difficulties and weak muscles.
  • On Nov. 11, ByHeart recalled all U.S. products, FDA inspectors visited production plants in Allerton, Iowa and Portland, Oregon, and families of affected babies filed lawsuits alleging negligence.
  • There is little danger of nationwide shortages because ByHeart holds about 1% of the U.S. market and sold about 200,000 cans monthly, while Health Secretary Robert F. Kennedy Jr. has directed an FDA review of formula nutrients.
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vcpost.com broke the news in on Wednesday, November 26, 2025.
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