We have filed the second of what will be dozens more lawsuits against ByHeart today in Federal Court in California on behalf of a family whose baby was hospitalized with infant botulism after consuming botulism-tainted ByHeart formula. Since the announcement a week ago last Saturday, Marler Clark has been contacted by over a dozen families across the United States impacted in August to November 2025. Marler Clark has also been retained to investigated infant botulism cases from late 2024 into early 2025 where infants also consumed ByHeart formula.
Bill Marler, food safety advocate and foodborne illness attorney since 1993, whose Seattle area law firm, Marler Clark’s work was recently profiled in the Netflix documentary “Poisoned,” The Dirty Truth about your Food, is calling again on ByHeart to pay the medical bills and lost wages of the families of victims of the Botulism outbreak in the United States that has so far sickened 24.
“Unfortunately, those infants sickened will likely rise in the coming weeks,” Marler said. “The cost of treating victims of Botulism infections can run in the tens of thousands of dollars, or in a severe case, even in the hundreds of thousands of dollars. These families need ByHeart to do more than promise to cooperate in the investigation into this outbreak. They need to know that ByHeart intends to fulfill their corporate responsibility by looking out for their customers,” added Marler.
Marler noted that over the last two decades in other outbreak-situations, companies such as Chi-Chi’s, Dole, Jack in the Box, Conagra, Odwalla and Sheetz advanced medical costs for outbreak victims whose illnesses were traced to their food products.
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.
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.
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.
William “Bill” Marler has been a food safety lawyer and advocate since the 1993 Jack-in-the-Box E. coli Outbreak which was chronicled in the book, “Poisoned” and in the recent Emmy Award winning Netflix documentary by the same name. Bill work has been profiled in the New Yorker, “A Bug in the System;” the Seattle Times, “30 years after the deadly E. coli outbreak, A Seattle attorney still fights for food safety;” the Washington Post, “He helped make burgers safer, Now he is fighting food poisoning again;” and several others.
Dozens of times a year Bill speaks to industry and government throughout the United States, Canada, Europe, Africa, China and Australia on why it is important to prevent foodborne illnesses. He is also a frequent commentator on food litigation and food safety on Marler Blog. Bill is also the publisher of Food Safety News.