Infant Botulism Outbreak Linked to Infant Formula, November 2025

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Key points

Investigation status: Closed
Recall issued: Yes
  • This outbreak is over, but activities to determine the root cause of C. botulinum in ByHeart powdered infant formula continue.
  • The outbreak included 28 confirmed cases and 20 probable cases.
  • No new cases have been added since December 2025, and 3 previously reported cases of suspected infant botulism from 3 states have been excluded.
Updates Locations Timeline

Fast Facts

  • Cases: 48
  • Hospitalizations: 48
  • Deaths: 0
  • States: 17
Updates Locations Timeline

Recalled infant formula

On November 11, 2025, ByHeart recalled all infant formula products.

Parents and caregivers are urged to stop using any ByHeart Whole Nutrition infant formula immediately. This includes:

  • All lot numbers
  • All sizes of cans and single serve packets

ByHeart Whole Nutrition infant formula was available for sale online and at major retailers nationwide.

What you should do

Actions to take

  • Do not use the recalled formula
    This includes ByHeart Whole Nutrition infant formula sold in cans and single serve packets.
  • Wash items and surfaces
    Wash items and surfaces that may have touched the formula using hot soapy water or a dishwasher.
  • Seek care if your infant becomes ill
    Seek immediate medical care if your infant has consumed the formula and has any symptoms of infant botulism.

Symptoms of infant botulism can take as long as several weeks to develop, so parents should remain vigilant if they used ByHeart Whole Nutrition infant formula.

Notice

To report a complaint or adverse event (illness or serious allergic reaction), visit FDA's Safety Reporting Portal. If your child has signs or symptoms of infant botulism, seek medical attention before using the portal.

What businesses should do

  • Do not sell or use recalled ByHeart Whole Nutrition infant formula.
  • Wash and sanitize items and surfaces that may have touched recalled formula.

What clinicians should do

Initial diagnosis of infant botulism is based on clinical symptoms. Consultation with the Infant Botulism Treatment and Prevention Program is available 24 hours a day, 7 days a week.

Actions to take

  • Call
    If you suspect your infant patient has botulism, immediately call 510-231-7600 for case consultation.
  • Treat
    If clinical consultation supports infant botulism, begin treatment as soon as possible. Do not wait for laboratory confirmation.
  • Notify
    Infant botulism is a notifiable disease. Report all suspected cases to your state public health department.
For Health Care Providers Clinical Overview of Infant Botulism

Symptoms

Symptoms usually start with

  • Constipation
  • Poor feeding
  • Loss of head control
  • Difficulty swallowing

If left untreated, infant botulism can weaken muscles used in breathing. This can lead to breathing problems and require weeks of hospitalization.

All infants with suspected botulism should be treated with BabyBIG®, a medication used to treat infant botulism.

Keep Reading About Botulism

See also

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Content Source:
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)