Background
Infant botulism is rare but serious. Spores of Clostridium botulinum (or related toxin-producing clostridia) can germinate in an infant’s immature gut and produce botulinum toxin, causing progressive weakness, poor feeding, and breathing difficulty. Before 2025, no outbreak of infant botulism had ever been linked to powdered infant formula anywhere in the world.
That changed with two outbreaks. ByHeart Whole Nutrition Infant Formula was linked to 48 hospitalized infants (illness onsets December 2023–November 2025). Nara Organics Whole Milk Organic Powdered Infant Formula was linked to 4 hospitalized infants (April–May 2026). All 52 infants were hospitalized; none died. Both brands recalled all product. Whole-genome sequencing later showed the two outbreaks shared a common source: organic whole milk powder supplied by Organic West Milk and spray-dried by Dairy Farmers of America.
What changed
FDA’s current finished-product testing rules for powdered infant formula require checks for Cronobacter and Salmonella, but not for botulinum-toxin-producing clostridia. The organism reached finished formula via a dairy ingredient. In July 2026 FDA sent the industry a letter urging stronger supplier oversight; it has also done limited surveillance sampling of powdered milk. A draft citizen petition (comments due 30 October 2026) from attorney Bill Marler and parents of affected infants asks FDA to add the organism to the required testing list for finished product and to require testing of the dairy ingredients themselves. Parallel legislation (S. 272 and a House bill) has been introduced.
Competing viewpoints
What to watch next
Sources: FDA outbreak pages and post-outbreak response activities, CDC, Contemporary Pediatrics, Marler Blog (draft petition), Food Safety News.
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