Infant Botulism Outbreak Linked to Powdered Formula

Agencies are investigating a multistate outbreak of 13 infant botulism illnesses from 10 states linked to ByHeart powdered infant formula.

The U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC), in collaboration with the California Department of Public Health (CDPH), the Infant Botulism Treatment and Prevention Program (IBTPP), state and local partners, are investigating the outbreak.

Illnesses have been reported in Arizona, California (2), Illinois (2), Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas (2) and Washington. Laboratory confirmation for some cases is ongoing, said FDA. There are no deaths reported at this time.

The CDPH IBTPP reported an increase in number of botulism type A infections among infants consuming ByHeart powdered infant formula from August to November 2025. All 13 cases included in the outbreak are reported to have consumed ByHeart brand powdered infant formula, said FDA.

Officials in several states have collected leftover infant formula for testing. This testing is underway, and results are not yet available but expected in the coming weeks, said the agency.

FDA contacted the firm and recommended it conduct a voluntary recall due to the number of cases, severity of illness and strong epidemiological signal. ByHeart initiated a recall of the two lots of ByHeart Whole Nutrition Infant formula (Lot: 206VABP/251261P2 and Lot: 206VABP/251131P2) that were reported to have been consumed by infants.

FDA said it is continuing to work with the firm to ensure all potentially impacted product is removed from the market.

ByHeart Whole Nutrition Infant Formula makes up an estimated less than 1% of all infant formula sold in the U.S., according to FDA. The outbreak does not create shortage concerns of infant formula for parents and caregivers, the agency said.

FDA’s investigation is ongoing to determine the point of contamination and if any additional products are impacted. This advisory will be updated as information becomes available.