The FDA and CDC, in collaboration with the California Department of Public Health (CDPH), Infant Botulism Treatment and Prevention Program (IBTPP), and other state and local partners, continue to investigate a multistate outbreak of infant botulism. Epidemiologic and laboratory analyses indicate that ByHeart Whole Nutrition infant formula is the source of this multistate outbreak of

BEFORE THE UNITED STATES 

JUDICIAL PANEL ON MULTIDISTRICT LITIGATION 

 IN RE BYHEART INFANT BOTULISM LITIGATION   MDL DOCKET NO.               

PLAINTIFFS’ MOTION TO TRANSFER AND CENTRALIZE RELATED ACTIONS TO THE SOUTHERN DISTRICT OF NEW YORK PURSUANT TO 28 U.S.C. § 1407

Pursuant to 28 U.S.C. § 1407 and Rule 6.2 of the Rules of

ByHeath Botulism Infant Formula – 51 Sick and Hospitalized

As of December 17, 2025, this outbreak includes 51 infants with suspected or confirmed infant botulism from 19 states. Laboratory confirmation for some cases is ongoing. Illnesses started on dates ranging from December 24, 2023, through December 1, 2025.

All 51 infants were hospitalized and treated with BabyBIG®. No