FDA and CDC, in collaboration with the California Department of Public Health (CDPH), the Infant Botulism Treatment and Prevention Program (IBTPP), and other state and local partners, continue to investigate the multistate outbreak of infant botulism. Epidemiological and laboratory data indicate that ByHeart Whole Nutrition infant formula may be contaminated Clostridium botulinumwhich is the cause of childhood diseases in many 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 in 17 states – Arizona 3, California 5, Idaho 1, Illinois 2, Kentucky 1, Massachusetts 2, Maine 1, Michigan 1, Minnesota 2, North Carolina. 2, New Jersey 1, Oregon 3, Pennsylvania 1, Rhode Island 1, Texas 8, Washington 2 and Wisconsin 1. Laboratory confirmation of some cases is ongoing. In the 36 cases for which onset information was available, illness onset occurred between August 9 and November 19, 2025. All 37 infants were hospitalized. There have been no reports of deaths to date. Of the 35 infants for whom age and sex information was available, they ranged in age from 16 to 264 days, and 15 (43%) were girls.
State and local public health officials are asking caregivers about the foods infants were fed in the month before they became ill. Thirty-seven infants were identified who were fed ByHeart Whole Nutrition powdered infant formula before they became ill.
The FDA has received reports that the recalled formula is still found on store shelves in several states, including several Walmart, Target and Kroger locations, as well as 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 stores. The FDA is working with government partners and retailers to ensure an effective recall and immediate removal of these products from store shelves nationwide. All ByHeart baby food products have been recalled and these products should not be available for sale in stores or online. This includes all single serving cans of formula and sticks “in any package.”
Additional testing by ByHeart, FDA, CDC and state partners is ongoing, with results expected in the coming weeks.
The FDA investigation, including on-site inspections, continues to determine the location of the contamination. FDA issues FDA Establishment Inspection Reports (EIRs) and FDA Form 483, Inspection Observations. based on 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.
The FDA's investigation continues to determine the location of the contamination. This advisory will be updated as information becomes available.
Number of cases
Total diseases: 37 (6 new)
Hospitalizations: 37 (6 new)
Deaths: 0
Last illness: November 19, 2025
State with cases: AZ, CA, CA, ID, ID, KY, MA, ME, ME, MN, NC, NJ, OR, OR, RI, TX, WA, WW
Product Distribution: Online and nationwide (including Guam and Puerto Rico) and internationally
Useful links
Product Images
Examples of results
Product sampling and testing is conducted by the FDA, CDC, government partners and ByHeart. Available information on positive samples is listed below. This table will be updated as additional results become available or are submitted to the FDA.
Due to the large number of samples, only positive results are reported here. Detection Clostridium botulinum in infant formula is challenging, and a negative test result does not rule out the presence of bacteria in the product.
Parents and guardians should not use ByHeart infant formula, regardless of test results.
| Sample collected/analyzed | Product | Test result | Type of toxin |
|---|---|---|---|
| CDPH | ByHeart Baby Food Jar (Part Number 251131P2) | Positive | Type A |
| by heart | ByHeart Infant Formula (batch/batch not specified) | Positive | Type A |
International distribution
The ByHeart baby formula recall will impact markets outside the United States. Customer information provided by Amazon shows that limited quantities of the recalled ByHeart infant formula were distributed in Argentina, Brazil, Brunei, Canada, Chile, China, Colombia, Ecuador, Egypt, Hong Kong, Israel, Jamaica, Japan, Republic of Korea, Peru, Philippines, Romania, Singapore, South Africa, Thailand and the British Virgin Islands.
Consumers worldwide should not use ByHeart brand infant formula as all ByHeart products are included in this recall.
