The Centers for Disease Control and Prevention announced on June 13 that a multistate outbreak of infant botulism has been linked to recalled Nara Organics Whole Milk Organic Infant Formula. Three infants from California, Pennsylvania, and Washington were reported to have developed infant botulism after consuming the formula. The affected infants ranged in age from two to five months when their illness began. All three were hospitalized and treated with BabyBIG, an FDA-approved treatment for infant botulism. No deaths have been reported.
Nara Organics issued a recall of all its Whole Milk Organic Infant Formula products on June 13. The recall covers all lot numbers and both available can sizes, which are sold online and at major retailers nationwide. Testing is ongoing for both opened cans involved in the cases and unopened product samples, with results expected in the coming weeks.
The CDC urges parents and caregivers to immediately stop using any Nara Organics Whole Milk Organic Infant Formula. Unopened cans should be discarded or returned, while opened cans should be labeled as ‘DO NOT USE’ and stored away from other food items for at least one month if no symptoms appear before disposal. If an infant develops symptoms such as poor feeding, loss of head control, difficulty swallowing, or decreased facial expression after consuming the product, medical care should be sought immediately.
Symptoms of infant botulism may take several weeks to develop following exposure. Parents are advised to monitor their children who consumed the affected formula for one month after last use. To report complaints or adverse events related to this product, individuals are directed to use the FDA’s Safety Reporting Portal, but seek medical attention first if symptoms arise.
Clinicians are encouraged by the CDC to diagnose suspected cases based on clinical presentation rather than waiting for laboratory confirmation, and begin treatment promptly if consultation supports a diagnosis of infant botulism.