INDIANA – The FDA and CDC, in collaboration with the California Department of Public Health (CDPH), Infant Botulism Treatment and Prevention Program (IBTPP), and other state and local partners, continue to investigate a multistate outbreak of infant botulism. Epidemiologic and laboratory data show that ByHeart Whole Nutrition infant formula might be contaminated with Clostridium botulinum, which is causing infant illness in multiple regions of the country.
As of November 26, 2025, a total of 37 infants with suspected or confirmed infant botulism and confirmed exposure to ByHeart Whole Nutrition infant formula (various lots) have been reported from 17 states.
Laboratory confirmation for some cases is ongoing. Of 36 cases with illness-onset information available, illnesses began on dates ranging from August 9 to November 19, 2025. All 37 infants were hospitalized. No deaths have been reported to date. For 35 infants with age and sex information available, they range in age from 16 to 264 days, and 15 (43%) are female.
State and local public health officials are interviewing caregivers about the foods infants were fed in the month before they became ill. Thirty-seven infants have been identified who were fed ByHeart Whole Nutrition powdered infant formula before getting sick.
FDA has received reports that recalled formula is still being found on store shelves in multiple states, including at numerous Walmart, Target, and Kroger locations, and at one or more Sprouts Organic Market, Safeway, Acme, Jewel-Osco, Shaw’s, Star Market, Smith’s, King Sooper’s, Albertson’s, Whole Foods, Wegman’s, and Publix locations. FDA is working with state partners and retailers to ensure an effective recall and the immediate removal of these products from store shelves nationwide. All ByHeart infant formula products have been recalled and should not be available for sale in stores or online. This includes all formula cans and single-serve “anywhere pack” sticks.
Additional testing by ByHeart, FDA, CDC, and state partners is underway, and results are expected in the coming weeks. Positive sample results will be included and updated in the Sample Information section below.
FDA’s investigation, including onsite inspections, is ongoing to determine the point of contamination. FDA is releasing the FDA Establishment Inspection Reports (EIRs) and FDA Form 483s, Inspectional Observations from completed inspections previously conducted between 2022 and March 2025 at ByHeart facilities. ByHeart, Inc. is the parent company of three Blendhouse manufacturing facilities in Allerton, Iowa; Portland, Oregon; and Reading, Pennsylvania.
- Blendhouse Allerton: the facility was last inspected in February 2025 and classified Voluntary Action Indicated (VAI), which cited GMP deficiencies
- Blendhouse Portland: the facility was last inspected in March 2025 and classified No Action Indicated (NAI)
- Blendhouse Reading: the facility was last inspected in January 2024 and classified Official Action Indicated (OAI). This facility has not been in operation since September 2023.
FDA’s investigation is ongoing to determine the point of contamination. This advisory will be updated as information becomes available.
