“We are deeply disappointed and will do everything we can to support you,” By Heart co-owners wrote in a letter on Nov. 11 after learning of the botulism outbreak among infants.
ByHeart infant formula linked to botulism in 10 states
The FDA is asking parents to throw out certain lots of ByHeart Whole Nutrition infant formula after it has been linked to an outbreak of infant botulism.
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Byheart, the Next Generation infant nutrition company at the center of a national infant formula recall, is being sued by the parents of at least two infants who have fallen ill in the ongoing infant botulism outbreak.
On November 8, “out of an abundance of caution” By Heart voluntarily recalled two batches of By Heart Whole Nutrient Infant Milk during an investigation into an infant botulism outbreak by the Food and Drug Administration and the Centers for Disease Control and Prevention. On November 11, the company expanded its recall to include all batches of ByHeart Whole Nutrition Infant Formula cans and Anywhere Packs nationwide.
According to the FDA, as of Friday, Nov. 14, a total of 23 infants with suspected or confirmed infant botulism diagnoses and confirmed exposure to ByHeart Whole Nutrition infant formula (various lots) have been reported from 13 U.S. states. No deaths have been reported so far, but all 23 infants have been hospitalized, the agency said.
Stephen and Eulanie Dexter of Flagstaff, Arizona, and Michael and Hannah Everett of Richmond, Kentucky, filed suit in federal court against Byhart after their babies contracted the rare and potentially fatal disease. Both families claim that Byhart was the direct cause of their infant’s botulism.
USA TODAY contacted ByHeart on Nov. 15 but did not receive a response.
We will introduce the family story and the current state of the recall.
Why are families suing ByHeart?
According to a federal complaint filed Nov. 12 in U.S. District Court in Arizona, the Dexters said they fed their baby girl Beihart infant formula from July 2025 until she showed signs of infant botulism. The family said the child was “born healthy, alert and happy” on July 5, and then decided on July 8 to introduce BiHeart Milk as a supplement to breast milk, the complaint continues.
By Aug. 21, the baby began experiencing “stomach discomfort and gas,” and her feedings were steadily decreasing, according to the family. “She appeared hungry, but as soon as the bottle touched her lips, she refused to eat. Eventually, she stopped eating altogether,” the complaint states.
After initially being diagnosed with candidiasis, a common fungal infection in the mouth, the girl’s symptoms worsened until Aug. 31 when her parents were “unable to wake her,” according to the complaint. The child had to be airlifted from the emergency room to Phoenix Children’s Hospital on the night of Sept. 2, according to the complaint. Upon arrival, he received an intravenous fluid, a feeding tube and antivenom, as well as occupational, physical and speech therapy.
The Dexters’ baby was discharged from the hospital on Sept. 13 with a feeding tube, but now cannot be left alone while awake, according to the complaint.
Similarly, the Everetts said their 4-month-old baby girl was “happy and healthy” until she was given Byheart infant formula, according to a complaint filed Nov. 12 in federal court in the Eastern District of Kentucky. The parents said their child became “lethargic and constipated” after ingesting the formula in early November, according to the complaint.
Within a few days, the baby began exhibiting “neurological symptoms, including an inability to feed from a bottle,” the suit says. The girl was admitted to the hospital on Nov. 9, where she was diagnosed with infantile botulism and ordered to undergo antitoxin treatment, according to the complaint.
The Kentucky Department of Public Health began investigating the situation and quickly determined that the child had received one of the Byheart infant formulas that was originally recalled, according to the complaint.
“It was really scary,” Hannah Everett told CBS News. “You know, we felt like we failed as parents in a way.”
Both families are seeking medical expenses, a jury trial and other damages incurred during the baby’s hospitalization.
What does ByHeart say about the formula recall?
Byheart co-owners Mia Funt and Ron Belldegrun shared a letter on the company’s website and social media pages on Nov. 11, saying in part: “Upon learning of this outbreak on Friday evening, we immediately responded to all ByHeart batches with our own large-scale In addition, we have provided the FDA with full and unrestricted access to all of our facilities and products for investigation, which is conducted regularly at our facilities. We will share the results of our own tests from time to time.” ”
“The most important thing we want you to know at this time is that all Byheart products must be discarded. We understand that switching formulas is not an easy process or decision, and our website has resources to help,” the letter reads. “We are very sorry, but we will do our best to support you.”
The company added, “It is important for you to know that neither we, the FDA, nor the CDC have found Clostridium botulinum spores or toxins in unopened cans of Byheart formula.”
Baby formula recall: See U.S. states with reported cases of infant botulism
According to the FDA, 22 of the 23 confirmed cases for which onset information is available had onset dates between August 9 and November 11. In addition, the 22 infants for whom age and gender information were available ranged in age from 16 to 200 days, and 10 (45%) were female.
The U.S. states where cases of infant botulism have been reported are:
- arizona
- California
- kentucky
- illinois
- minnesota
- Michigan
- new jersey
- north carolina
- Oregon
- pennsylvania
- rhode island
- texas
- washington
How far is the FDA investigating?
In a Nov. 14 update on the investigation, the FDA said it was conducting on-site inspections and collecting samples to determine the location of the contamination.
“My hope right now is that we can get the virus out before these kids get seriously ill, before they need ventilators,” Hannah Everett said, according to CBS News.
Stephen Dexter, 44, told the outlet that he never imagined “that a product designed for the helpless, developing population of America could cause such serious consequences.”
What are the symptoms of infant botulism?
According to the CDC, parents or guardians who experience the following symptoms in their infants should seek immediate medical attention:
- poor feeding
- loss of head control
- difficulty swallowing
- decrease in facial expressions
Symptoms of botulism can take several weeks to develop, so parents or guardians who have recently fed their infants with the recalled formula should continue to be cautious.
What should consumers do?
ByHeart said consumers who purchased ByHeart Whole Nutrition Infant Formula cans and Anywhere Packs “must immediately discontinue use and discard the products.”
“If your infant is experiencing symptoms associated with infant botulism, please contact your healthcare provider immediately,” the company said in its Nov. 11 recall. To report an illness or adverse event, consumers can:
Parents with questions can contact the company’s experts at hello@byheart.com. For more information, visit byheart.com or call 1 (833) 429-4327. According to the company, it is available 24 hours a day, 365 days a year.
