Investigation status:

Open



Recall issued:

Yes

CDC, public health officials in several states, the California Department of Public Health Infant Botulism Treatment and Prevention Program, and the U.S. Food and Drug Administration, are investigating a multistate outbreak of infant botulism linked to infant formula. Infant botulism happens when a baby swallows Clostridium botulinum spores that grow in the gut and make toxin. Infant botulism often starts with constipation but is usually first noticed as difficulty feeding (sucking and swallowing), a weak and altered cry, and lack of head control.

  • Cases: 37 (6 new)
  • Hospitalizations: 37 (6 new)
  • Deaths: 0
  • States: 17 (2 new)

Recalled infant formula

On November 11, 2025, ByHeart Inc. 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

  • Do not use any ByHeart Whole Nutrition infant formula. This includes formula sold in cans and single serve packets.
    • If possible, take a picture or record the lot number and use by date.
    • If you have leftover ByHeart powdered formula, label it “DO NOT USE” and keep it stored in a safe place for at least a month.
    • If your infant develops symptoms of infant botulism, your state health department may want to collect the formula for testing. If no symptoms appear after a month, throw the leftover formula away.
  • Seek immediate medical care if your infant has consumed ByHeart Whole Nutrition Infant Formula and has any of these symptoms:
    • Poor feeding
    • Loss of head control
    • Difficulty swallowing
    • Decreased facial expression
  • 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.
  • California Department of Public Health has a public hotline to support caregivers with concerns about this outbreak and infant botulism.
    • Available daily, 7 a.m. to 8 p.m. Pacific Standard Time
    • 1-833-398-2022
  • To report a complaint or adverse event (illness or serious allergic reaction), visit FDA’s Safety Reporting 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
  • If clinical consultation supports infant botulism, begin treatment as soon as possible. Do not wait for laboratory confirmation.
  • Infant botulism is a notifiable disease. All suspected cases must be reported to the state public health department.

Symptoms

  • Most infants with infant botulism will initially develop constipation, poor feeding, loss of head control, and difficulty swallowing.
  • If untreated, infants with infant botulism experience a progressive, flaccid paralysis that can lead to breathing difficulties and require weeks of hospitalization.
  • Treatment with BabyBIG® is recommended for all suspected cases of infant botulism.



Content Source:

National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)