Health officials and federal agencies have escalated their response to a multistate cluster of infant botulism after laboratory and epidemiologic evidence pointed to powdered infant formula as a likely vehicle. Public-health investigators in the U.S., led by the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA), are working with state partners to confirm case counts, sequence isolates, test product lots, and trace distribution pathways as quickly as possible.

What’s New (latest developments)

Federal and state public-health agencies now say that epidemiologic and laboratory evidence links ByHeart Whole Nutrition powdered infant formula to a cluster of infant botulism cases (CDC.gov). On November 11, 2025, ByHeart initiated a voluntary recall

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