State of California—Health and Human Services Agency
California Department of Public Health

Health Advisory

TO: Healthcare Providers

Outbreak of Infant Botulism Linked to Nara Organics Whole Milk Organic Infant Formula

6/17/2026

Key Messages

The California Department of Public Health (CDPH), the Centers for Disease Control and Prevention (CDC) and other state health departments are investigating a multi-state outbreak of infant botulism linked to powdered infant formula.
Three infants with laboratory confirmed infant botulism have been identified who had exposure to the same brand of powdered infant formula including one (1) in California, one (1) in Pennsylvania and one (1) in Washington. As of June 15, 2026, all three cases have been confirmed and there are no additional suspected cases presently.
Illness onset dates range from late April to May 31, 2026. All infants were hospitalized and received BabyBIG^®. No deaths have been reported. Infants ranged in age from 86 to 153 days. All three were fed Nara Organics Whole Milk Organic Infant Formula powdered.
Testing of the open can of Nara Organics powdered infant formula fed to the California patient is ongoing at the California Department of Public Health Center for Laboratory Sciences Microbial Diseases Laboratory (CDPH CLS MDL).
On June 13, 2026, Nara Organics issued a voluntary recall of all lots of its powdered infant formula nationwide. FDA is working to ensure all potentially impacted products are removed from the market. FDA's investigation is ongoing.
Parents should discontinue use of Nara Organics formula immediately.
Nara Organics Whole Milk Organic Infant Formula powdered was available online and at Target retailers nationwide. FDA reports that Nara Organics Whole Milk Organic Infant Formula makes up less than 1% of all infant formula sales in the United States. This recall will not create shortage concerns of infant formula for parents and caregivers.
Clinicians and public health professionals should call the CDPH Infant Botulism Treatment and Prevention Program (IBTPP) directly for consultation for suspected infant botulism cases at 510-231-7600 (available 24/7).
Health care providers should report suspected cases of infant botulism to their local health department immediately, to facilitate investigation, testing and timely treatment with BabyBIG^® if indicated.

Background

Infant botulism is caused by colonization with Clostridium botulinum spores, which germinate and produce botulinum neurotoxin in the intestine. The immature gut microbiota and immune system and reduced bile acid levels in infants create a permissive environment for spore germination and toxin production. Infant botulism occurs when swallowed spores of Clostridium botulinum or related botulinum-neurotoxin-producing species temporarily colonize a baby's large intestine and produce toxin. The toxin is then absorbed and carried in the baby's bloodstream to the neuromuscular junction where it cleaves key intracellular proteins needed for the release of the neurotransmitter acetylcholine. Signs of infant botulism include poor or decreased head control, poor feeding (weak suck, difficulty swallowing), hypotonia (floppy baby syndrome), weak or altered cry, decreased facial expression, ptosis, progressive, symmetric, descending flaccid paralysis and respiratory failure in severe cases. Constipation is often the earliest sign of infant botulism; however, constipation by itself is not diagnostic. Infant botulism primarily affects infants under six months of age. Botulism, including infant botulism, is a nationally notifiable disease in the U.S. Infant botulism is usually sporadic, and for most cases, a source is not identified.

Diagnosis is based on clinical history and physical exam along with testing for botulinum neurotoxin in stool. Confirmatory testing includes detection of botulinum neurotoxin in stool or isolation of C. botulinum or neurotoxigenic C. baratii or C. butyricum from stool. This testing can be done at the CDPH laboratory.

Treatment should not be delayed while awaiting laboratory confirmation.

BabyBIG® (Human Botulism Immune Globulin Intravenous) is the treatment of choice and should be administered as soon as infant botulism is suspected. BabyBIG® is only available through the CDPH IBTPP. BabyBIG^® does not reverse existing paralysis; it neutralizes ongoing toxemia and stops the progression of the disease, allowing healing to begin. Meticulous supportive care is a mainstay of treatment; respiratory and nutritional support is often required. Hospitalization is typically prolonged (weeks), but prognosis is excellent with timely treatment.

Providers caring for a patient with suspected infant botulism should notify their local health department and immediately reach out to the Infant Botulism Treatment and Prevention Program (IBTPP) for medical consultation: Call 510-231-7600 (available 24/7).

Recommendations

Maintain a high index suspicion for infant botulism and ask parents about the use of Nara Organics infant formula in any suspected cases

Parents of children with suspected infant botulism are encouraged to retain opened containers and save lot numbers and expiration dates of any infant formula consumed by the child and report to their local health department.

If infant botulism is suspected, consult with experts at the CDPH Infant Botulism Treatment and Prevention Program immediately at 510-231-7600. Consultation is available 24/7.
If clinical consultation supports a diagnosis of infant botulism, begin treatment with BabyBIG® as soon as possible. Do not wait for laboratory confirmation.
Infant botulism is a notifiable disease. All suspected cases must be reported immediately by telephone to the local health department of the patient's residence.