This health alert is to remind all health care providers that all ByHeart Whole Nutrition Infant Formula products have been recalled. This includes all unexpired lots of formula cans and single-serve “anywhere pack” sticks. Providers should advise patients and their families and caregivers that no one should consume any ByHeart infant formula products. Testing of infant formula associated with suspected cases in Maine may be performed by federal partners as appropriate and in consultation with the Maine Center for Disease Control and Prevention (Maine CDC).
The Maine CDC’s Health and Environmental Testing Laboratory (HETL) does not conduct tests for botulism. Suspect human botulism specimens should be sent directly to U.S. CDC after consultation with U.S. CDC and/or the Infant Botulism Treatment and Prevention Program (IBTPP) at the California Department of Public Health (if infant botulism is suspected). Providers should not wait for laboratory confirmation to initiate case management. If clinical consultation supports infant botulism, begin immediate treatment with BabyBIG®.
The Maine CDC is currently investigating one suspected botulism case in a Maine infant who consumed ByHeart infant formula. The suspected case is currently hospitalized and will be treated with BabyBIG®. Confirmatory testing is underway. As of November 14, 2025, this multi-state outbreak includes 23 infants with suspected or confirmed infant botulism from 13 states.
Health care providers should immediately report suspected cases of botulism to the Maine CDC at 1-800-821-5821. Additional information about the outbreak is available in the U.S. CDC Partners Email (included in the advisory linked below) and on the U.S. CDC’s and FDA’s websites. The Maine CDC’s updates to the letter are in italics.