Health Alert: Recall Issued for Nara Organics Infant Formula Amid Botulism Investigation

Federal health officials are investigating a multistate outbreak of infant botulism linked to the consumption of Nara Organics Whole Milk Organic Infant Formula. As of June 13, 2026, the Centers for Disease Control and Prevention (CDC) has confirmed three cases of the rare but serious illness in California, Pennsylvania, and Washington. All affected infants, ranging from two to five months old, required hospitalization and treatment with the antitoxin BabyBIG®. No fatalities have been reported as of mid-June 2026.

Why Was Nara Organics Formula Recalled?

Nara Organics issued a voluntary recall of all lot numbers and sizes of its Whole Milk Organic Infant Formula on June 13, 2026, following the identification of the botulism cluster. The investigation is currently focused on identifying the source of Clostridium botulinum spores, which produce the dangerous neurotoxin associated with infant botulism. The U.S. Food and Drug Administration (FDA) and state health departments are conducting laboratory testing on both opened containers from the affected households and unopened product samples to determine if the formula is the definitive vehicle for the transmission of these spores.

Recognizing Symptoms of Infant Botulism

Infant botulism occurs when Clostridium botulinum spores are ingested, colonize the large intestine, and release a toxin that affects the nervous system. According to the CDC, parents should monitor their infants for symptoms for up to one month after the child last consumed the recalled product. Clinical warning signs include:

• Constipation (often the first symptom)
• Poor feeding or difficulty latching
• Loss of head control (floppiness)
• Difficulty swallowing
• Decreased facial expression or “flat” affect
• Weak or altered cry

Immediate Steps for Caregivers

Caregivers who have purchased Nara Organics infant formula should immediately discontinue use. If you have the product in your home, follow these safety guidelines provided by federal health authorities:

• Unopened product: Dispose of the formula or return it to the point of purchase.
• Opened product: If you must keep the container for potential testing, label it “DO NOT USE,” store it securely away from other food items, and photograph the lot number and use-by date. If no symptoms appear after 30 days, discard the container.
• Sanitization: Thoroughly clean all surfaces, bottles, and utensils that have come into contact with the formula using hot, soapy water or a high-temperature dishwasher cycle.

Clinical Guidance for Healthcare Providers

The CDC emphasizes that the diagnosis of infant botulism is primarily clinical. Clinicians should not delay the administration of BabyBIG®—the FDA-approved human-derived botulism immune globulin—while waiting for laboratory confirmation. Early intervention is critical to preventing the progression of flaccid paralysis and potential respiratory failure. Providers suspecting a case should contact their local or state health department immediately for guidance on obtaining treatment.

Reporting and Further Information

If an infant exhibits symptoms consistent with botulism, seek emergency medical care immediately rather than using online reporting tools. For non-emergency concerns or to report an adverse event related to infant formula, the FDA Safety Reporting Portal is available for public use. Further updates regarding the investigation will be posted on the official CDC botulism outbreak webpage as laboratory results become available.