Botulism Outbreak Linked to ByHeart Infant Formula Hospitalizes 51 Infants

In an unprecedented public health event, at least 51 infants across 19 U.S. states have been hospitalized due to botulism linked to ByHeart's Whole Nutrition infant formula. This marks the first recorded outbreak of infant botulism associated with infant formula in the United States.

The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) have expanded their investigation to include all ByHeart products produced since the company's launch in March 2022. Laboratory tests confirmed the presence of Clostridium botulinum in multiple batches of the formula. In response, ByHeart issued a nationwide recall of all its infant formula products on November 11, 2025.

Despite the recall, some products reportedly remained on store shelves, raising concerns about distribution and recall effectiveness. Infant botulism is a rare but serious illness caused by bacterial spores that produce toxins in the intestines. Symptoms can take up to 30 days to appear and include constipation, feeding difficulties, weakness, and drooping eyelids. Treatment involves hospitalization and administration of BabyBIG®, a specialized antitoxin.

This outbreak has prompted multiple lawsuits against ByHeart, alleging the sale of contaminated formula. The FDA has initiated inspections of ByHeart's facilities in Iowa and Oregon to determine the source of contamination.

ByHeart emphasized its collaboration with the FDA and commitment to safety, stating it is independently testing all formula batches and granting regulators full access to its facilities. This incident has heightened concerns about infant formula safety and the effectiveness of recall processes. Parents and caregivers are urged to stop using any ByHeart Whole Nutrition infant formula immediately.

This is the first recorded outbreak of infant botulism linked to infant formula in the United States, marking a significant event in public health and food safety. The ByHeart infant formula botulism outbreak has raised critical questions about food safety, regulatory oversight, and the responsibilities of infant formula manufacturers. Ongoing investigations aim to prevent future incidents and ensure the health and safety of infants nationwide.