The Food and Drug Administration and Centers for Disease Control and Prevention are continuing the investigation into a multistate outbreak of infant botulism linked to ByHeart Whole Nutrition infant formula.
The formula may be contaminated with Clostridium botulinum.
As of November 26, 2025, 37 infants have been hospitalized with suspected or confirmed cases of infant botulism across 17 states, all of whom were exposed to ByHeart Whole Nutrition infant formula. The illnesses began between August 9 and November 19, 2025, but no deaths have been reported.
The following states reported cases:
- Arizona
- California
- Idaho
- Illinois
- Kentucky
- Massachusetts
- Maine
- Michigan
- Minnesota
- North Carolina
- New Jersey
- Oregon
- Pennsylvania
- Rhode Island
- Texas
- Washington
- Wisconsin
The FDA has reported that the recalled ByHeart formula is still being found on store shelves in multiple states, including at major retailers such as Walmart, Target, and Kroger. Efforts are underway to ensure an effective recall and immediate removal of these products from stores nationwide.
The investigation involves the FDA, CDC, California Department of Public Health, and other state and local partners. State and local health officials are interviewing caregivers about the foods the infants consumed before falling ill.
ByHeart, Inc., the parent company of the formula, operates three Blendhouse manufacturing facilities in Allerton, Iowa; Portland, Oregon; and Reading, Pennsylvania. The FDA’s ongoing investigation includes inspections of these facilities to determine the contamination source.
The Blendhouse Allerton facility was last inspected in February 2025 and classified as Voluntary Action Indicated due to GMP deficiencies. The Portland facility was last inspected in March 2025 with no action indicated, while the Reading facility, which has not been operational since September 2023, was classified as Official Action Indicated after its last inspection in January 2024.
The investigation continues as authorities work to ensure the safety of infant formula products and prevent further cases of botulism.
Additional testing by ByHeart, FDA, CDC, and state partners is ongoing, with results expected in the coming weeks.
© 2025 Cox Media Group
