In an update released on January 23, the U.S. Food and Drug Administration (FDA) shared information about a contaminated ingredient in the multistate outbreak of infant botulism associated with ByHeart powdered infant formula. FDA is collaborating on the outbreak with the Centers for Disease Control and Prevention (CDC) and the California Department of Public Health's Infant Botulism Treatment and Prevention Program (IBTPP).
As of January 23, 2026, two samples collected by FDA have tested positive for Clostridium botulinum toxin Type A. One sample came from a closed canister of ByHeart powdered infant formula and matches a clinical isolate from an infant included in the outbreak, according to whole genome sequencing (WGS) analysis.