The International Food Safety Authorities Network (INFOSAN) Secretariat is alerting global partners to an ongoing infant botulism incident in the United States of America associated with the consumption of contaminated ByHeart Whole Nutrition Infant Formula.
As of 17 November 2025, the U.S. Centers for Disease Control and Prevention (CDC) has reported 23 suspected and confirmed cases across 13 U.S. states, all of which required hospitalization. Parents and caregivers in the USA have been strongly advised to immediately stop using all ByHeart Whole Nutrition Infant Formula, regardless of lot number, can size, or whether the product was purchased as single-serve packets.
INFOSAN is in communication with the INFOSAN Emergency Contact Point in the USA to obtain further updates regarding control measures and possible international distribution. Authorities have confirmed that this product was sold online through major retail platforms, including Amazon.com.
Amazon has notified all customers who purchased ByHeart products through its platform. INFOSAN is currently awaiting confirmation on which countries may have received shipments through Amazon’s distribution channels.
For more information on the incident, please refer to the following sources:
CDC: CDC – Infant Botulism and Infant Formula Outbreak, November 2025
Food Safety News: More babies sick in botulism outbreak traced to ByHeart powdered formula | Food Safety News
FDA: Outbreak Investigation of Infant Botulism: Infant Formula (November 2025) | FDA
