FDA, CDC investigating multistate infant botulism outbreak tied to formula

The FDA and Centers for Disease Control and Prevention (CDC) are recommending that parents and caregivers stop using any ByHeart infant formula products immediately, because of an ongoing investigation into a multistate outbreak of infant botulism. According to a November 11, 2025, press release from the federal agency, epidemiologic and laboratory data showed that ByHeart Whole Nutrition Infant Formula might be contaminated with Clostridium botulinum.¹

Ongoing outbreak of infant botulism

As of November 10, 2025, there were a total of 15 infants with suspected or confirmed infant botulism and confirmed exposure to various lots of ByHeart Whole Nutrition Infant Formula, from 12 states. All 15 infants have been hospitalized and no deaths have been reported as of November 11, 2025.

The FDA stated that laboratory confirmation for some cases is ongoing and that for 14 cases in which illness onset was available, illnesses started on dates ranging from August 9 to November 10, 2025.

The updated outbreak information and recall of all of ByHeart products sold nationwide follows an initial recall of 2 lots of infant formula on November 8, 2025.^2,3 According to an article from The Associated Press, the recall includes the Whole Nutrition Infant Formula and Anywhere Pack pouches of powdered formula. Devon Kuehn, chief medical officer at ByHeart, told The Associated Press that the company sells approximately 200,000 cans of formula per month online and in stores such as Whole Foods, Walmart, Target, and Albertsons, along with other major retailors^1,2

Arizona, California, Illinois, Kentucky, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington are states with reported cases.

What is infant botulism?

The rare but serious illness is caused by a toxin that attacks the body's nerves, resulting in difficulty breathing, muscle paralysis, and even death. All 5 "main kinds" of botulism are considered to be medical emergencies by the CDC.⁴

"The bacteria that make botulinum toxin are found naturally in many places, but it's rare for them to make people sick. These bacteria make spores, which act like protective coatings. Spores help the bacteria survive in the environment, even in extreme conditions," notes the CDC.

For infant botulism, the federal agency states, "For reasons we do not understand, some infants get botulism when the spores get into their intestines, grow, and produce the toxin."

FDA recommendations

The FDA recommends the following if parents or caregivers suspect or have purchased ByHeart infant formula products¹:

• Parents and Caregivers should stop using any ByHeart infant formula products immediately.
• If your child consumed ByHeart formula and is experiencing symptoms (see below) seek immediate medical attention.
• If your child consumed ByHeart formula and is not currently showing symptoms, continue monitoring them and seek medical attention if symptoms develop.
• If you still have the formula in your home, you should:
  • Take a photo or record the information on the bottom of the package.
  • Keep the container in a safe spot and be sure to label that product as DO NOT USE.
  • If your child develops symptoms, your state health department might want to collect your formula container for testing. If your child does not develop symptoms after 30 days, throw your containers out.
• Botulism can be fatal, and you should take action right away. If your child has consumed ByHeart Whole Nutrition Infant Formula and is experiencing signs and symptoms of botulism such as poor feeding, loss of head control, difficulty swallowing, or decreased facial expression, seek immediate medical attention. 
• If you are a Physician and suspect an infant patient has botulism, immediately call 510-231-7600 for case consultation. Consultation is available 24/7.

References:

1. Outbreak Investigation of Infant Botulism: Infant Formula (November 2025). FDA. Press release. November 11, 2025. Accessed November 11, 2025. https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-infant-botulism-infant-formula-november-2025
2. Aleccia J. ByHeart recalls all baby formula sold nationwide as infant botulism outbreak grows. The Associated Press. November 11, 2025. Accessed November 11, 2025. https://apnews.com/article/byheart-baby-formula-infant-botulism-recall-e070565daaf1f425e3d37dca20277714
3. Infant botulism in 10 US states linked to formula being recalled. The Associated Press. November 8, 2025. Accessed November 11, 2025. https://apnews.com/article/infant-botulism-formula-byheart-recall-fda-cdc-91019e385a98a2fceb26a12005ea3fbb
4. About botulism. Centers for Disease Control and Prevention. Updated April 18, 2024. Accessed November 11, 2025. https://www.cdc.gov/botulism/about/index.html