Est. 2026 · Armando Cuesta, MD, Founding Editor

The Vital Record

The daily record of medicine and biotech.

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Monday, 15 June 2026 edition — The Vital Record

FDA & Regulatory

FDA and CDC Investigate Nationwide Voluntary Recall of Nara Organics Powdered Infant Formula After Three Infants Hospitalized With Botulism

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.

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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