Outbreak Investigation: Infant Botulism Linked to Infant Formula (November 2025)

November 8, 2025

The FDA and CDC, in collaboration with California Department of Public Health (CDPH), Infant Botulism Treatment and Prevention Program (IBTPP), and state and local partners, are investigating a multistate outbreak of 13 infant botulism illnesses from 10 states: Arizona, California (2), Illinois (2), Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas (2), Washington. Laboratory confirmation for some cases is ongoing. 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 2025 to November 2025. All 13 cases included in this outbreak are reported to have consumed ByHeart- brand powdered infant formula. 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.

FDA has been in contact with the firm and has recommended the firm conduct a voluntary recall due to the number of cases, severity of illness, and the strong epidemiological signal. Today, ByHeart, Inc. agreed to initiate 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 the infants. FDA is continuing to work with the firm to ensure all potentially impacted product is removed from the market.

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.   

Case Counts

Total Illnesses: 13
Hospitalizations: 13
Deaths: 0
Last Illness Onset: November 2025
States with Cases: AZ, CA, IL, MN, NJ, OR, PA, RI, TX, WA 
Product Distribution: Online and nationwide

Useful Links

• CDC Outbreak Advisory
• Infant Botulism Treatment and Prevention ProgramExternal Link Disclaimer
• Food Safety Tips for Retailers and Consumers During an Outbreak
• Food Safety Resources for Produce Shippers and Carriers During a Foodborne Illness Outbreak
• Who to Contact
• What is Botulism?

Consumers who have symptoms should contact their health care provider to report their symptoms and receive care.