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Health officials are investigating a multistate outbreak of infant botulism linked to ByHeart Whole Nutrition infant formula. The Centers for Disease Control and Prevention (CDC) announced that as of November 11, 15 infants in 12 states have been reported with suspected or confirmed cases. Botulism is a rare but serious illness caused by a bacteria that produces a nerve toxin and can lead to paralysis or death if not treated promptly.

All ByHeart Whole Nutrition Infant Formula products, including cans and single-serve sticks, have been recalled. The formula accounts for about 1% of U.S. infant formula sales, so shortages are not expected.

Parents and caregivers should stop using the formula immediately, save leftover product for possible testing, clean any surfaces it touched, and watch infants for symptoms such as poor feeding, trouble swallowing, loss of head control, weak facial expressions, or breathing difficulties. Symptoms can appear weeks after exposure.

Healthcare providers are advised to evaluate infants showing symptoms, contact the California Department of Public Health for guidance, and start treatment with BabyBIG® without waiting for lab confirmation. Suspected cases must be reported to state health departments, and lab testing is coordinated through the CDC.