Situation summary
- Centers for Disease Control and Prevention (CDC), Food & Drug Administration (FDA), and California Department of Public Health (CDPH) Infant Botulism Treatment and Prevention Program (IBTPP) are investigating a multistate outbreak of infant botulism linked to recalled Nara Organics Whole Milk Organic Infant Formula.
- As of June 13, 2026, 3 cases have been reported in this outbreak from California, Pennsylvania, and Washington.
- Although infant botulism is potentially fatal, no deaths have been reported to date.
- On June 13, 2026, Nara Organics recalled all Nara Organics Whole Milk Organic Infant Formula. This includes Nara Organics Whole Milk Organic Infant Formula in both package sizes (400g and 700g) and from any retailer.
- According to the FDA, this formula was sold at Target retail stores, Target.com, and Nara.com between July 2025 and June 2026.
- According to the FDA, Nara Organics Whole Milk Organic Infant Formula makes up less than 1% of all infant formula sold in the United States so this recall is not expected to cause any overall shortage of infant formula in the United States.
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 Tacoma-Pierce County Health Department at (253) 649-1412 AND 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, called Botulism Immune Globulin Intravenous (Human) (BIG-IV), known as BabyBIG.
- Healthcare providers who suspect botulism in an adult should immediately call Tacoma-Pierce County Health Department at (253) 649-1412.
- If IBTPP recommends treatment for 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.
- Clinical specimen testing for infants with suspected infant botulism is available through Washington State Department of Health (DOH) Public Health Laboratories.
- Work with us 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 to:
- Seek healthcare immediately if their infant develops symptoms of infant botulism.
- Immediately stop using Nara Organics Whole Milk Organic Infant Formula.
- 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. Find the lot code on the bottom of each can.
- Wash items and surfaces that may have touched the recalled formula with 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 caused by spores of Clostridium botulinum bacteria, which can 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, respiratory failure, and death.
Affected infants have difficulty with feeding and often with breathing. However, in the absence of other complications, infants can 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.