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November 14, 2025

Infant botulism associated with ByHeart Infant Formula in the U.S.

➜ This health advisory is also available in PDF format (239 KB)

Current situation

On November 8th, 2025, the 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 one infant in Washington state. Although infant botulism is potentially fatal, no deaths have been reported at this time; several cases remain hospitalized. 


On November 11, 2025, Food and Drug Administration (FDA) announced an updated recall of the formula, sold under the name ByHeart Whole Nutrition Infant Formula. The recall includes ALL lot numbers of ByHeart Whole Nutrition Infant Formula sold in cans and single-serving packets.

Actions requested

  • Identify

    Be alert for infants presenting with symptoms consistent with infant botulism. Early recognition and treatment are critical. Symptoms can include:

    • 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
    • If left untreated: symmetric, descending flaccid paralysis

  • Manage

    • Immediately contact the California Department of Public Health Infant Botulism Treatment and Prevention Program (IBTPP) at 510-231-7600 for clinical consultation if you suspect infant botulism.
      • Consultation is available 24 hours a day, 7 days a week.
      • The IBTPP serves the entire country and provides evaluation and access to treatment for infants - Botulism Immune Globulin Intravenous (Human) (BIG-IV), known as BabyBIG®.
      • For suspected botulism in ADULTS, please call Public Health at 206-296-4774.

    • If clinical consultation supports infant botulism, begin treatment with BabyBIG® without delay. Do not wait for laboratory confirmation.
      • Administering BabyBIG® will prevent progression of paralysis, but it will not reverse symptoms. 

  • Test

  • Notify

    • Immediately report suspected cases of botulism to Public Health at 206-296-4774.

  • Counsel

    Advise parents/guardians whose infants consumed this product to:

    • Seek healthcare immediately if their infant develops symptoms of infant botulism.
      • Clinical testing of infants who have used this formula but are NOT symptomatic is not currently recommended.
      • Symptoms of infant botulism can take several weeks to develop, so encourage parents to carefully watch their infants for symptoms.
    • Do not use any ByHeart Whole Nutrition infant formula. This includes formula sold in cans and single serve packets.
    • If they currently have any ByHeart Whole Nutrition infant formula:
      • If possible, take a picture or record the lot number and "use by" date.
      • Put the formula into a container/bag, label it "DO NOT USE" and keep it stored in a safe place (like a high cabinet) for at least a month.
      • If their infant develops symptoms of infant botulism, Public Health may want to collect it for testing. If no symptoms appear after a month, throw the leftover formula away.
      • If they are unable to safely store and label the leftover formula, discard the product or return it to the place of purchase.
    • Wash items and surfaces that may have touched the recalled formula using hot soapy water or a dishwasher.

Background

Infant botulism is a novel form of human botulism in which ingested spores of the Clostridium botulinum bacteria colonize and grow in an infant's large intestine. C. botulinum produces a neurotoxin that blocks the neuromuscular junction by inhibiting the release of acetylcholine. Initial signs and symptoms often include constipation, difficulty feeding (difficulty sucking or swallowing), loss of head control, weak facial expression, and reduced muscle tone. If left untreated, symptoms will progress to a symmetric, descending flaccid paralysis, respiratory failure, and possibly death. The time from ingestion to symptom presentation can be up to 30 days.

Prompt administration of BabyBIG® can prevent intubation and avoid extended hospitalization. Additional treatment is supportive, including nutritional and respiratory support as needed.

Washington State has an average of four cases of infant botulism annually. Most affected infants are six months or younger, although cases can occur until the first birthday. Spores are widely distributed in the environment and specific exposures are rarely identified. Since honey can contain the spores, it should not be given to infants.

Resources

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