The CDC and FDA have not updated the numbers of ill for a few weeks. Hopefully, the numbers have peaked at 51 – I just would not count on it.
Here, however, is the reality. I got off the phone a few days ago with a young, single mom whose baby was hospitalized for months in an Oregon hospital pediatric intensive care unit (PICU) and is still on a feeding tube due to damage sustained from the botulism toxin. The baby further is suffering from weakness in one leg. The future for this child is guarded.
In the meantime, ByHart’s big firm lawyers are hiring experts, serving subpoenas and ignoring requests to step up to pay medical expenses and wage losses incurred by these families – all whose children were hospitalized – all the while depleting the limited insurance that ByHeart has to compensate these infants, a.k.a. “burning” limits.
This is less a legal battle – it is more a moral question.
And, do not get me started on the retailers that are trying to ignore this – that will be changing.
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.
ByHeart’s and FDA’s investigations into the root cause of the outbreak are ongoing, and at this time, FDA cannot rule out the possibility that contamination might have affected all ByHeart formula products. In response, CDC broadened the case definition to include any infant with botulism who was exposed to ByHeart formula at any time since the product’s release in March 2022. As of December 10, 2025, a total of 51 infants with suspected or confirmed infant botulism and confirmed exposure to ByHeart Whole Nutrition infant formula (various lots) have been reported from 19 states. States with illnesses: Arizona 5, California 12, Idaho 2, Illinois 2, Kentucky 1, Massachusetts 2, Maine 1, Michigan 1, Minnesota 3, North Carolina 2, New Jersey 1, Ohio 1, Oregon 4, Pennsylvania 1, Rhode Island 1, Texas 8, Virginia 1, Washington 2 and Wisconsin 1.
Previously, case counts included illnesses from August 1, 2025, onward. With the expanded definition, CDC and state partners identified 10 additional cases that occurred from December 2023 through July 2025. At this time, no cases have been identified between March 2022 and December 2023. All 10 are confirmed infant botulism cases with documented exposure to ByHeart formula.
Laboratory confirmation for some cases is ongoing. Illnesses started on dates ranging from December 24, 2023 to December 1, 2025. All 51 infants were hospitalized. No deaths have been reported to date. The infants range in age from 16 to 264 days and 22 (43%) are female.
State and local public health officials are interviewing caregivers about the foods the infants were fed in the month before they got sick. Fifty-one infants have been identified that were fed ByHeart Whole Nutrition powdered infant formula before getting sick.
FDA has not received reports of recalled formula being found on store shelves since November 26, 2025. 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.
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.
FDA’s investigation is ongoing to determine the point of contamination. This advisory will be updated as information becomes available.
Botulism: Marler Clark, The Food Safety Law Firm, is the nation’s leading law firm representing victims of Botulism outbreaks. The Botulism lawyers of Marler Clark have represented thousands of victims of Botulism and other foodborne illness outbreaks and have recovered over $900 million for clients. Marler Clark is the only law firm in the nation with a practice focused exclusively on foodborne illness litigation. Our Botulism lawyers have litigated Botulism cases stemming from outbreaks traced to carrot juice, pesto, cheese and chili.
If you or a family member became ill with Botulism after consuming food and you’re interested in pursuing a legal claim, contact the Marler Clark Botulism attorneys for a free case evaluation.
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.