New Recall: Infant Botulism Outbreak Linked to Powdered Infant Formula
In June 2026, the CDC and state health partners are investigating a multistate outbreak of infant botulism linked to contaminated powdered infant formula. Infant botulism is a rare but serious illness caused by Clostridium botulinum spores that can grow in an infant’s gut and produce toxins affecting the nervous system.
The outbreak has been linked to Nara Organics Whole Milk Organic Infant Formula, which has been voluntarily recalled. As of June 2026, three confirmed cases have been identified across three states. All affected infants required hospitalization, and no deaths were reported. Laboratory evidence supported a link to the recalled formula, while the source of contamination remained under investigation.
Caregivers should always contact their infant’s doctor right away if they notice trouble sucking and swallowing, a weak or altered cry, and/or loss of muscle tone, as these can be signs of botulism.
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FDA Investigation Summary: Infant Botulism Outbreak Linked to Infant Formula (November 2025)
In November 2025, the FDA, CDC, and state partners investigated a multistate outbreak of infant botulism linked to contaminated powdered infant formula.
The outbreak was associated with ByHeart Whole Nutrition infant formula, leading to a nationwide recall of all lots. Caregivers were advised to stop using the product immediately, watch for symptoms (including poor feeding, constipation, weakness, and breathing difficulty), and seek urgent medical care if symptoms developed. The formula had been widely distributed across the U.S. through retail and online channels.
All confirmed cases occurred in infants who had consumed the recalled formula, and all required hospitalization and treatment with BabyBIG® antitoxin. No deaths were reported. Epidemiologic and laboratory findings supported a link to the product, though the exact source of contamination remained under investigation.
By early 2026, the CDC had reported no new cases since December 2025, indicating the outbreak had ended. The investigation identified dozens of confirmed and probable cases across multiple states, making it a notable recent outbreak.
Officials emphasized that infant botulism remains rare but highlighted the importance of rapid recalls, early symptom recognition, and safe formula preparation practices.