The Centers for Disease Control and Prevention (CDC) is informing medical and public health partners about a current multistate outbreak of infant botulism linked to Nara Organics Whole Milk Organic Infant Formula powdered. This communication is intended to help local public health prepare, identify cases early, manage suspected cases, and implement appropriate reporting and public health actions.
Outbreak information
A multistate outbreak of infant botulism has been identified in the United States. As of June 13, 2026, this outbreak includes 3 infants with confirmed or suspected infant botulism from 3 states (California, Pennsylvania, and Washington). All 3 infants were hospitalized and treated with BabyBIG® (Botulism Immune Globulin Intravenous medication). No deaths have been reported.
The CDC National Botulism Surveillance System records approximately 150–180 infant botulism cases each year.
Data shared by the Infant Botulism Treatment and Prevention Program (IBTPP), have demonstrated a concerning association between consumption of Nara Organics Whole Milk Organic Infant Formula and botulism. Among 86 U.S. infants who received BabyBIG® treatment for infant botulism this year, 44 (51%) had any powdered infant formula exposure. Notably, 3 (7%) consumed Nara Organics Whole Milk Organic Infant Formula. This information shows that Nara Organics brand formula is disproportionately represented among sick infants in this outbreak, given Food and Drug Administration's (FDA) data that Nara Organics represents an estimated <1% of all infant formula sales in the United States. Investigations are ongoing but, at this time, have not identified any other infant formula brands or shared exposures that pose a risk to infants.
CDC and FDA recommend that parents and caregivers immediately stop using all Nara Organics Whole Milk Organic Infant Formula. On June 13, 2026, Nara Organics recalled all infant formula products. FDA does not anticipate any formula shortages as a result of this outbreak.
What is infant botulism?
Infant botulism is an intestinal toxemia that occurs when an infant ingests spores of Clostridium botulinum bacteria, which then grow in the large intestine and produce toxin 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. Without prompt recognition and treatment, descending paralysis may progress and involve the respiratory muscles, potentially leading to life-threatening respiratory failure. The time from ingestion to symptom presentation can be up to 30 days.
Recommendations for clinicians and public health partners
Consider infant botulism as a clinical diagnosis in any infant presenting with unexplained weakness, poor feeding, decreased head control, or difficulty swallowing, especially if the infant has consumed Nara Organics infant formula.
Immediate actions when suspecting infant botulism
- Do not wait for laboratory confirmation to initiate case management. Early recognition and treatment are critical.
- Immediately call the Infant Botulism Treatment & Prevention Program (IBTPP) at 510-231-7600 for evaluation and treatment guidance. Consultation is available 24 hours a day, 7 days a week.
- If clinical consultation supports infant botulism, begin treatment with BabyBIG® without delay. Do not wait for laboratory confirmation.
- Infant botulism is a notifiable disease. Ensure all suspected cases are reported immediately to your state or local health department.
Guidance for caregivers
- Do not use any Nara Organics Whole Milk Organic Infant Formula.
- Unopened cans of Nara Organics infant formula should be thrown away or returned.
o Leftover cans of Nara Organics brand powdered infant formula should be labelled "DO NOT USE" and kept stored in a safe place away from other feeding items for at least a month.
§ If your infant develops signs and 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.
- Wash items and surfaces that may have touched the formula using hot soapy water or a dishwasher.
- Seek immediate health care if the infant consumed Nara Organics infant formula and has any of these symptoms:
o Poor feeding
o Loss of head control
o Difficulty swallowing
o Decreased facial expression
Symptoms of infant botulism can take several weeks to start. Parents of children who consumed Nara Organics infant formula should watch their infant for symptoms for a month after the infant last consumed the product.
Institutions, hospitals, clinical labs, and public health partners
- Do not use or distribute any of the recalled Nara Organics brand infant formula. Remove it from inventory and inform relevant staff.
- Clean and sanitize feeding areas and equipment that may have been exposed.
- Ensure clinical labs and pathology services are aware that infant botulism is a reportable condition and laboratory confirmation is critical for case investigation; ensure timely specimen collection and consultation with the state or local health departments for information on specimen collection and confirmatory testing.
- Participate in trace-back, leftover product collection, and laboratory testing as requested by state health departments, CDC, and FDA.
Why this matters and next steps
CDC, FDA, IBTPP, and public health officials in several states are working to determine the contamination source and to issue further guidance as information becomes available. For clinicians and health‐care systems, preparedness means:
- recognizing the signs and symptoms of infant botulism promptly
- having protocols in place for consultation and treatment
- ensuring awareness of case notification procedures
- providing caregivers with clear instructions when feeding concerns arise
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- Please report suspect cases immediately to your state and local health department.
- For clinical questions about suspected infant botulism cases and release of BabyBIG® please contact the Infant Botulism Treatment & Prevention Program (IBTPP) at 510-231-7600.
- For health departments, CDC's Division of Foodborne, Waterborne, and Environmental Diseases is available to answer questions and receive case reports at botresponse@cdc.gov.
- For public health and investigation inquiries, please contact the CDC Emergency Operations Center at 770-488-7100 (after hours) or your state or local health department.
Resources
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Tucker O'Donnell
MCAH Director
National Association of County and City Health Officials (NACCHO)
Washington DC
(484)645-2505
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