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Health Advisory: Infant Botulism Associated with ByHeart Infant Formula

Summary

  • On Nov. 8, 2025, Centers for Disease Control and Prevention (CDC) announced an outbreak of infant botulism linked to infant formula.
  • Since August 2025, at least 23 cases have been identified in 13 states, including 1 case in an infant who resided in Washington at the time of exposure.
  • Although infant botulism is potentially fatal, no deaths have been reported to date. Several infants remain hospitalized.
  • Food and Drug Administration (FDA) announced a recall of the formula, sold under the name ByHeart Whole Nutrition Infant Formula.
  • Initially, only 2 lots of formula were involved in the recall. However, on Nov. 11, 2025, FDA recalled all lots of ByHeart Whole Nutrition Infant Formula sold in 24 oz. cans and 0.6 oz. “anywhere” single-serving packets.

Actions requested

  • Healthcare providers should be alert for infants presenting with symptoms consistent with infant botulism:
    • Constipation.
    • Poor feeding
    • Diminished suck and gag reflexes.
    • Ptosis/drooping eyelids
    • Altered/blunted facial expression.
    • Decreased pupillary reaction or dilated pupils.
    • Weak or altered cry.
    • Poor head control.
    • Hypotonia and generalized weakness.
    • Symmetric, descending flaccid paralysis.
  • Healthcare providers who suspect botulism in an infant based on symptoms should immediately contact California Department of Public Health Infant Botulism Treatment and Prevention Program (IBTPP) at (510) 231-7600 for clinical consultation.
    • Consultation is available 24 hours a day, 7 days a week.
    • IBTPP serves the entire country and provides clinical consultation and access to treatment for infant botulism.
    • IBTPP provides access to treatment for Infant Botulism—Botulism Immune Globulin Intravenous (Human) (BIG-IV), known as BabyBIG®
  • Healthcare providers who suspect botulism in an adult should call Tacoma-Pierce County Health Department at (253) 649-1412.
  • If clinical consultation supports infant botulism, begin treatment with BabyBIG® as soon as possible. Do not wait for laboratory confirmation.
    • Administering BabyBIG® will prevent progression of paralysis, but it will not reverse symptoms.
  • Infant botulism (and other types of botulism) is a notifiable condition in Washington State.
    • Report cases of suspected botulism to Tacoma-Pierce County Health Department at (253) 649-1412.
  • Clinical specimen testing for infants with suspected infant botulism is available through Washington State Department of Health (DOH) Public Health Laboratories.
    • Work with us and DOH to arrange testing for infants that are being treated for suspected infant botulism.
    • Collect a stool or enema specimen following specimen collection and transport guidance from DOH Public Health Laboratories.
  • Advise parents/guardians whose infants consumed the product of the following:
    • Seek healthcare immediately if their infant develops symptoms of infant botulism.
    • Immediately stop using ByHeart Whole Nutrition Infant Formula, including unopened 24 oz. cans and 0.6 oz. single-serving packets.
    • Keep the formula for a month and label, “DO NOT USE”. If possible, record (photograph or write down) lot numbers of opened formula that their infant(s) consumed before discarding.
    • Wash items and surfaces that may have touched the recalled formula using hot soapy water or a dishwasher.
    • We do not recommend clinical testing of infants who have used this formula but are asymptomatic.
      • Instead, encourage parents to carefully watch their infants for symptoms.
    • Symptoms of infant botulism can take several weeks to develop.
      • Advise parents to remain vigilant for symptoms if their infant has consumed this formula.

Background

Infant botulism is a rare illness where spores of Clostridium botulinum bacteria colonize and grow in an infant’s large intestine. These bacteria release a neurotoxin that causes symptoms like constipation, weakness (especially in sucking, crying, and swallowing), and loss of muscle tone. If untreated, the condition can lead to paralysis, trouble breathing, and death.

Affected infants have difficulty with feeding and often with breathing. However, in the absence of other complications, infants recover completely from the disease.

Washington has an average of 4 cases of infant botulism annually. Most affected infants are 6 months or younger, although cases can occur until the first birthday. Spores are widely distributed in the environment and specific exposures are rarely identified. Identification of a contaminated commercial product, as in the current situation, is rare. Honey can contain spores so infants should not be fed honey or foods containing honey.

Administering Botulism Immune Globulin Intravenous (Human) (BIG-IV), also known as BabyBIG® will prevent symptom progression but does not reverse existing symptoms of botulism toxin. Prompt administration of BabyBIG® can prevent intubation and avoid extended hospitalization. Additional treatment is supportive including nutritional and respiratory support as needed.

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