Marler Clark, The Food Safety Law Firm, Files First Infant Formula Botulism Case ByHeart Brand Linked to Outbreak that Sickened 15 in 12 states

BAINBRIDGE ISLAND, Wash., Nov. 12, 2025 /PRNewswire/ -- A lawsuit was filed today in court on behalf of Stephen and Yurany Dexter, parents of E.D.( a minor), against ByHeart, Inc. The Dexter's are represented by Marler Clark, The Food Safety Law Firm and O'Steen, MacLeod & Combs PLC of Phoenix, Arizona. The case was filed in the United States District Court in the District of Arizona. Case filing # 2:25-at-99911

The Dexter's infant, E.D., was born on July 5^th, 2025 and introduced to ByHeart baby formula as a supplement to breast milk. On August 21, 2025, E.D. began to experience stomach discomfort and gas, steadily decreasing her intake until after a week, despite seeming hungry, she refused to eat. Over the next several days, her parents attempted to feed her by syringe which was unsuccessful as she was unable to swallow. 

Seeking medical attention, the Dexter's rushed her to Phoenix Children's Hospital and were informed that since botulism was so rare, a diagnosis of muscular dystrophy was more likely. E.D.'s symptoms worsened and she could not suck, swallow, smile, hold her head up, move her limbs normally, or cry with normal strength. Her cry was faint and weak. The Dexter's feared E.D. might die or might never recover fully. Their infant was treated with BabyBIG antitoxin, and began occupational, physical and speech therapy. Several weeks later the Dexters brought E.D. home from the hospital with an IV feeding tube where she is still recovering and experiencing digestive and strength issues. The long-term effects of Botulism are not known for E.D., but after this trauma she has developed separation anxiety and requires constant contact with her caregivers.

Outbreak Facts and Public Health Actions

As of November 10, 2025, 15 infants with suspected or confirmed infant Botulism were identified by health officials from 12 states: Arizona 1, California 2, Illinois 2, Kentucky 1, Minnesota 1, North Carolina 1, New Jersey 1, Oregon 1, Pennsylvania 1, Rhode Island 1, Texas 2 and Washington 1. Illness onset for 14 of these cases started on August 9 to November 10, 2025. All 15 infants were fed ByHeart Whole Nutrition Powdered formula before getting sick. All 15 were hospitalized and treated with BabyBIG, an anti-toxin for botulism.

The FDA and CDC, in collaboration with state and local partners, are investigating this multi-state outbreak of infant Botulism. Lab results reported by the California Department of Public Health suggest the presence of bacteria that produce botulism toxin in an open can of ByHeart infant formula that was fed to a baby with who developed botulism. Additional testing is underway, and results are expected in the coming weeks.

The FDA has been in contact with ByHeart and has requested a recall expansion to include all ByHeart infant formulas on the market. On November 11, 2025, ByHeart expanded its recall to include all ByHeart formula nationwide, including cans and single-serve sticks.

Symptoms of Botulism in Infants

If your infant is experiencing any of these symptoms, please seek immediate medical attention. 

• Constipation: Often the first sign, with stools that may become less frequent and harder.
• Weakness: A general lethargy or decreased muscle tone (hypotonia), often described as "floppy baby syndrome."
• Poor Feeding: Difficulty feeding or sucking.
• Cranial Nerve Dysfunction: This can lead to symptoms such as: Weak cry or inadequate vocalization. Difficulty swallowing. Drooping eyelids or poor eye movement.
• Respiratory Problems: In severe cases, difficulty breathing due to muscle weakness can occur.
• Weakness in Movement: Reduced ability to move arms and legs.
• Irritability or unusual crying.

Champion of Food Safety

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.

Bill Marler practices at, Marler Clark, The Food Safety Law Firm, which is the nation's leading law firm representing victims of botulism outbreaks. Marler Clark is the only law firm in the nation with a practice focused exclusively on foodborne illness litigation. Bill has litigated botulism cases stemming from outbreaks traced to carrot juice, pesto, cheese and chili.

SOURCE Marler Clark, The Food Safety Law Firm