--- title: "More Infant Botulism cases linked to ByHeart formula – 24 to Date" date: 2025-11-15T02:45:34-08:00 author: Bill Marler canonical_url: "https://marlerclark.com/news_events/more-infant-botulism-cases-linked-to-byhearth-formula" section: News --- [All News](/news_events) / # More Infant Botulism cases linked to ByHeart formula – 24 to Date 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. Since the last update on November 11, 2025, nine new cases and one new state (Michigan) have been added to this investigation. All 9 cases were hospitalized and treated with BabyBIG®. As of November 14, 2025, this outbreak includes 24 infants with suspected or confirmed infant botulism from 13 states – Arizona 3, California 3, Illinois 2, Kentucky 1, Michigan 1, Minnesota 2, North Carolina 2, New Jersey 1, Oregon 2, Pennsylvania 1, Rhode Island 1, Texas 3, Washington 2. ![](https://www.marlerblog.com/files/2025/11/Screenshot-2025-11-14-at-12.47.19-PM-640x460.png)Laboratory confirmation for some cases is ongoing. For 22 cases with illness onset information available, illnesses started on dates ranging from August 9 to November 11, 2025 All 23 infants were hospitalized and treated with BabyBIG®. No deaths have been reported. For 22 infants with age and sex information available, they range in age from 16 to 200 days and 10 (45%) are female. ![](https://www.marlerblog.com/files/2025/11/Screenshot-2025-11-14-at-12.46.56-PM-640x558.png)As part of this investigation, officials in several states have collected leftover infant formula for testing. On November 8, 2025, preliminary laboratory results reported by the California Department of Public Health suggest the presence of the bacteria that produce botulinum toxin in an open can of ByHeart infant formula (lot 206VABP/251131P2) that was fed to an infant with infant botulism. Additional testing is underway, and results are expected in the coming weeks. Detection of *Clostridium botulinum* in infant formula is difficult, and a negative test result does not rule out the presence of the bacteria in the product. ![](https://www.marlerblog.com/files/2025/11/Screenshot-2025-11-14-at-12.54.21-PM-369x640.png)[](https://www.marlerblog.com/case-news/infant-botulism-cases-spike-linked-to-byheart-formula/#lxb_af-comments-jump) ### Other Botulism Lawsuits [Nara Organics Infant Formula Botulism Outbreak Lawsuits](https://marlerclark.com/the-ten-largest-foodborne-illness-outbreaks-in-the-u-s-since-1993-and-marler-clarks-role-in-them) [By Heart Infant Formula tied to Botulism Outbreak spikes to 51](https://marlerclark.com/by-heart-infant-formula-tied-to-botulism-outbreak) [Botulism Outbreak at Valley Oak Food and Fuel](https://marlerclark.com/botulism-outbreak-at-valley-oak-food-and-fuel) [Marler Clark Files Two Botulism Lawsuits](https://marlerclark.com/marler-clark-files-two-botulism-lawsuits) ### Lawsuit updates about foodborne illnesses 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The team at Marler Clark is here to answer all your questions. Find out if you’re eligible for a lawsuit, what questions to ask your doctor, and more. [ Get a free consultation ](https://marlerclark.com/contact) ##### Related Resources ###### [What is Botulism?](https://marlerclark.com/foodborne-illnesses/botulism/what-is-botulism) Botulism is a life-threatening paralytic illness caused by neurotoxins produced by an anaerobic, gram-positive, spore-forming bacterium—Clostridium botulinum. Botulism is a rare disease and only affects a few hundred persons each... ###### [Epidemiology and Microbiology of Botulism](https://marlerclark.com/foodborne-illnesses/botulism/epidemiology-and-microbiology-of-botulism) C. botulinum bacteria and spores are widely distributed in nature because they are indigenous to soils and waters. 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Common... ###### [Botulism Outcomes and Long-Term and Permanent Injury](https://marlerclark.com/foodborne-illnesses/botulism/botulism-outcomes-and-long-term-and-permanent-injury) In the past 50 years, mortality from botulism has fallen dramatically (from about 50% to 8%) because of advances in supportive care, which is the mainstay of treatment. The respiratory... ##### Outbreak Database #### Looking for a comprehensive list of outbreaks? The team at Marler Clark is here to answer all your questions. Find out if you’re eligible for a lawsuit, what questions to ask your doctor, and more. [ View Outbreak Database ](https://outbreakdatabase.com)