ByHeart Inc., the next-generation baby nutrition company at the center of a nationwide infant formula recall, is being sued by the parents of at least two babies sickened amid an ongoing infantile botulism outbreak.
On Nov. 8, in the midst of an infant botulism outbreak investigation by the Food and Drug Administration and the Centers for Disease Control and Prevention, ByHeart voluntarily recalled two batches of its ByHeart Whole Nutrition Infant Formula "out of an abundance of caution." On Nov. 11, the company expanded its recall to include all batches of ByHeart Whole Nutrition Infant Formula cans and Anywhere Pack nationwide.
As of Friday, Nov. 14, a total of 23 infants with suspected or confirmed infant botulism and confirmed exposure to ByHeart Whole Nutrition infant formula (various lots) have been reported from 13 U.S. states, according to the FDA. So far, no deaths have been reported, but all 23 infants were hospitalized, the agency said.
Two families, Stephen and Yurany Dexter of Flagstaff, Arizona, and Michael and Hanna Everett of Richmond, Kentucky, filed complaints in federal courts against ByHeart after their babies contracted the rare and potentially deadly disease. Both families allege that ByHeart is directly responsible for their infant children being sickened with botulism.
USA TODAY contacted ByHeart on Nov. 15, but has not received a response.
Here are the families' stories and the current status of the recall.
Why are families suing ByHeart?
The Dexters said they fed their baby girl ByHeart's infant formula from July 2025 until the child developed signs of infant botulism, according to the federal complaint filed Nov. 12 on U.S. District Court in Arizona. The family said their child was "born healthy, alert, and happy" on July 5, and then on July 8, they decided to introduce ByHeart formula as a supplement to breast milk, the complaint continues.
By Aug. 21, the family said their baby began having "stomach discomfort and gas," with her feeding steadily decreasing. "She appeared hungry but would refuse to eat as soon as the bottle touched her lips. Eventually, she stopped eating altogether," the complaint reads.
After initially being diagnosed with thrush, a common fungal infection inside the mouth, the infant girl's symptoms worsened until on Aug. 31, when her parents "could not wake her," according to the lawsuit. The child had to be airlifted from an emergency room to Phoenix Children’s Hospital on the night of Sept. 2. Once there, she received IV fluids, a feeding tube, antitoxin, as well as occupational, physical and speech therapy, the complaint says.
The Dexters' baby was discharged from the hospital on Sept. 13 with a feeding tube, and now she cannot be left alone while awake, according to the lawsuit.
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Similarly, the Everetts said their 4-month-old girl "was a happy, healthy" until she was fed ByHeart Infant formula, according to the complaint filed on Nov. 12 in federal court for the Eastern District of Kentucky. After consuming the formula in early November, the parents said their child "became lethargic and developed constipation," the lawsuit says.
Within days, the infant began exhibiting "disturbing neurological symptoms, including an inability to take a bottle," the complaint reads. On Nov. 9, the child was admitted to the hospital, where she was diagnosed with infant botulism and ordered to undergo antitoxin treatment, according to the lawsuit.
The Kentucky Department of Public Health launched an investigation into the situation and soon discovered the child received one of the initially recalled batches of ByHeart's formula, according to the complaint.
"It was just absolutely terrifying," Hanna Everett told CBS News. "You know, we just kind of felt like we failed as a parent in some ways."
Both families are seeking payment for medical costs accrued during their baby's hospital stays, a jury trial and other damages.
What has ByHeart said about the formula recall?
Byheart co-owners Mia Funt & Ron Belldegrun shared a letter on the company's website and social media pages on Nov. 11, saying, in part: "Upon learning about this outbreak on Friday evening, we immediately began conducting our own extensive testing on all ByHeart batches. Additionally, we are providing the FDA complete and unrestricted access to all of our facilities and products for their investigation, which has been done regularly at our owned facilities. We will share the results of our own testing as they become available."
"At this moment, the most important thing for you to know is that all ByHeart product must be discarded. We know that switching formulas is not an easy process or decision. We have resources to help on our website," the letter reads. "We are so sorry, and are committed to doing anything we can to support you."
The company added: "It’s important that you know that neither we, nor the FDA or CDC, have found Clostridium botulinum spores or toxins in any unopened can of ByHeart formula."

Baby formula recall: See US states with reported cases of infant botulism
For 22 of the 23 confirmed cases with illness onset information available, illnesses began on dates ranging from Aug. 9 to Nov. 11, according to the FDA. Additionally, 22 infants with age and sex information available range in age from 16 to 200 days, and 10 (45%) are female.
Here are the U.S. states with reported cases of infant botulism:
Arizona
California
Kentucky
Illinois
Minnesota
Michigan
New Jersey
North Carolina
Oregon
Pennsylvania
Rhode Island
Texas
Washington
Where is the FDA in its investigation?
According to the Nov. 14 update on its investigation, the FDA said it is conducting onsite inspections and collecting samples to determine the point of contamination.
"My hopes right now is that they're able to catch it before their children get too sick, before they have to be on ventilators," Hanna Everett said, per CBS News.
Stephen Dexter, 44, told the outlet that he would've never guessed "that a product designed for a helpless, developing human in the United States could cause something this severe."
What are the symptoms of infant botulism?
Parents and guardians who see the following symptoms in an infant should seek immediate medical care, according to the CDC:
Poor feeding
Loss of head control
Difficulty swallowing
Decreased facial expression
Parents and guardians who have recently fed their infant the recalled formula should remain vigilant, as botulism symptoms can take multiple weeks to develop.
What should consumers do?
ByHeart said consumers who have purchased ByHeart Whole Nutrition Infant Formula cans and Anywhere Pack "should immediately discontinue use and dispose of the product."
"If your infant is experiencing symptoms related to infant botulism, contact your health care provider immediately," the company said in its Nov. 11 recall. To report an illness or adverse event, consumers can:
Call an FDA consumer complaint coordinator if they desire to speak directly to a person about a problem.
Complete an electronic Voluntary MedWatch form online.
Complete a paper Voluntary MedWatch form that can be mailed to the FDA.
Any parents who have questions can contact the company's experts at [email protected]. For more information, visit byheart.com or call 1 (833) 429-4327. The company said it is available 24/7.
This article originally appeared on USA TODAY: Baby formula botulism lawsuits filed after ByHeart recall
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