FDA & Regulatory
Federal agencies are investigating a cluster of infant botulism cases across three states linked to a single formula brand; the contamination pathway remains unresolved and the formula has not tested positive for C. botulinum.
Marcus Webb, FDA & Regulatory Desk · 1 min read
Three infants — in California, Pennsylvania, and Washington — have been hospitalized with infant botulism in a multistate outbreak linked to Nara Organics Whole Milk Organic Infant Formula, federal health agencies announced June 13, 2026.
The affected infants ranged in age from 2 to 5 months when illness began. All three were hospitalized and received BabyBIG® (botulism immune globulin intravenous [human]), the only FDA-approved treatment for infant botulism. No deaths have been reported.
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