November 11, 2025
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ByHeart formula botulism outbreak grows to 15 infants in 12 states; two lots recalled

The outbreak linked to ByHeart baby formula has grown to at least 15 infants in 12 states, with nine confirmed cases of infant botulism type A and six additional cases pending, and two lots of the formula recalled. Preliminary testing found bacteria that produce botulism toxin in an open can fed to an ill infant — a California bioassay sickened mice quickly — and ByHeart is urging testing of unopened recalled cans while the FDA investigates; officials say at least 84 U.S. infants have been treated for botulism since August.

Health Public Safety

📌 Key Facts

  • Outbreak increased to at least 15 infants sickened across 12 states (up from 13 in 10 states); nine cases of infant botulism type A have been confirmed and six additional cases are pending confirmation.
  • California officials said a sample from an open can fed to an ill infant contained bacteria that produce botulism toxin; in a bioassay Dr. Erica Pan reported mice became sick quickly.
  • ByHeart urged families to have unopened cans from the recalled batches tested to provide clearer evidence about possible contamination.
  • California officials reported that at least 84 U.S. infants have been treated for botulism since August.
  • The FDA is investigating whether additional botulism cases are linked to ByHeart formula.

📰 Sources (2)

At least 15 infants sickened by baby formula-linked botulism, officials say
https://www.facebook.com/CBSHealth/ November 11, 2025
New information:
  • Case count increased to at least 15 infants sickened across 12 states (up from 13 in 10 states).
  • Nine cases of infant botulism type A confirmed; six additional cases pending confirmation.
  • California officials said a sample from an open can fed to an ill infant contained bacteria that produce botulism toxin, and Dr. Erica Pan noted mice in the bioassay became sick quickly.
  • ByHeart urged testing of unopened cans from the recalled batches to provide clearer evidence for families.
  • California officials said at least 84 U.S. infants have been treated for botulism since August; FDA is investigating whether additional cases are linked to ByHeart formula.
Preliminary tests find germ that causes botulism in ByHeart baby formula
PBS News by JoNel Aleccia, Associated Press November 10, 2025