Washington, D.C., USA- January 13, 2020: FDA Sign at its headquarters in Washington DC. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA.
Federal health authorities have announced the conclusion of a multistate outbreak of infant botulism associated with the recalled ByHeart infant formula products, having identified 48 confirmed and probable cases across the country.
On Thursday, the Centers for Disease Control and Prevention reported that no new cases have emerged since December 10, 2025. The outbreak ultimately comprised 28 confirmed cases and 20 probable cases after three previously reported illnesses were excluded.
Investigators from the U.S. Food and Drug Administration, CDC, and state health departments traced the illnesses back to ByHeart Whole Nutrition infant formula. All ByHeart formula products have been recalled.
Laboratory analyses detected several strains of Clostridium botulinum in clinical samples, finished products, and ingredients, including organic whole milk powder sourced from a dairy processor. Whole genome sequencing connected product samples to patient samples, although the FDA has yet to identify the exact source of the contamination.
ByHeart products represent approximately 1% of infant formula sales in the U.S., and officials indicated that the recall did not lead to wider supply shortages.
Infant botulism can result in symptoms such as constipation, poor feeding, muscle weakness, and breathing difficulties. Health officials have advised parents to discontinue the use of recalled products and to seek immediate medical attention if any symptoms arise.
