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 analyses indicate that ByHeart Whole Nutrition infant formula is the source of this multistate outbreak of infant botulism.
Since the last update on December 10, 2025, reports of cases linked to this outbreak have slowed, and public health officials have not added any new cases to this investigation. Going forward, instead of weekly updates, CDC will provide updates on this outbreak investigation when new information becomes available. FDA will continue to provide investigational updates as needed.
All ByHeart infant formula products have been recalled, and these products should not be available for sale in stores or online. This includes all formula cans and single-serve “anywhere pack” sticks. On December 12, 2025, FDA sent warning letters to four major retailers for failing to remove recalled ByHeart infant formula from their store shelves despite being notified of the recall. On December 15, 2025, FDA issued a press releaseand reminded industry about its legal duties regarding food recalls under the Federal Food Drug and Cosmetic Act. FDA asked companies to follow best practices when carrying out recalls. This is especially important for recalls involving foods for infants and young children, who are among our most vulnerable populations.
Additional testing by ByHeart, FDA, CDC, and state partners is underway, and results are expected in the coming weeks. Positive sample results for finished product testing will be included and updated in the Sample Results section below.
FDA’s investigation is ongoing to determine the point of contamination. This advisory will be updated as information becomes available.
Link to Case Count Map Provided by CDC Case Count Map Provided by CDC
Link to Case Counts Case Counts
Total Illnesses: 51
Hospitalizations: 51
Deaths: 0
Last Illness Onset: December 1, 2025
States with Cases: AZ, CA, ID, IL, KY, MA, ME, MI, MN, NC, NJ, OH, OR, PA, RI, TX, VA, WA, WI
Product Distribution: Online and nationwide (including Guam and Puerto Rico), and internationally
Link to Useful Links Useful Links
- CDC Outbreak Advisory
- Infant Botulism Treatment and Prevention ProgramExternal Link Disclaimer
- ByHeart Expanded Recall Announcement
- 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?
Link to Product Images Product Images
Link to Sample Results (Last updated 12/3/2025) Sample Results (Last updated 12/3/2025)
Product sampling and testing is being conducted by FDA, CDC, state partners, and ByHeart. Available information on positive samples is included below. This table will be updated as additional results become available or are shared with FDA.
Due to the large number of samples, only positive results are being reported here. The detection of Clostridium botulinum in infant formula is complex, and a negative test result does not rule out the presence of the bacteria in the product.
Parents and caregivers should not use any ByHeart infant formula, regardless of test results.
| Sample Collected/Analyzed by | Product | Test Result | Toxin Type |
| CDPH | Opened container of ByHeart Infant Formula (Batch No. 251131P2) | Positive | Type A |
| ByHeart | ByHeart Infant Formula (Batch/Batches Not Reported) | Positive | Type A |
| ByHeart | ByHeart Infant Formula (Batch/Batches Not Reported) | Positive | Type A |
| ByHeart | ByHeart Infant Formula (Batch/Batches Not Reported) | Positive | Type A |
| ByHeart | ByHeart Infant Formula (Batch/Batches Not Reported) | Positive | Type A |
| ByHeart | ByHeart Infant Formula (Batch/Batches Not Reported) | Positive | Type A |
Link to International Distribution International Distribution
The ByHeart infant formula recall impacts markets outside the United States. Customer information provided by Amazon shows that a limited quantity of recalled ByHeart infant formula was distributed to 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 any ByHeart brand infant formula as all ByHeart products are included in this recall.