ByHeart sued over recalled formula by parents of infants sickened with botulism
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Jonathan Limehouse, USA TODAY November 16, 2025 at 2:44 AM
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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.
Consumer Reports, the nonprofit known for testing and monitoring consumer-facing policy and products, released its annual risky food report in April, naming the 10 foods of 2024 that were subject to the most recalls and/or associated with the largest illness outbreaks. USA TODAY broke it down further on a what-you-need-to-know basis.
" style=padding-bottom:56%>Consumer Reports, the nonprofit known for testing and monitoring consumer-facing policy and products, released its annual risky food report in April, naming the 10 foods of 2024 that were subject to the most recalls and/or associated with the largest illness outbreaks. USA TODAY broke it down further on a what-you-need-to-know basis.
" data-src=https://s.yimg.com/ny/api/res/1.2/OIaDuBQk1nrNxd_YCJjDlQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTEyNDI7aD04NTE-/https://media.zenfs.com/en/usa_today_slideshows_242/ea62e25c5245aae282619b85b061ab5e class=caas-img data-headline="See the 'risky foods' linked to recent US recalls and illness outbreaks" data-caption="
Consumer Reports, the nonprofit known for testing and monitoring consumer-facing policy and products, released its annual risky food report in April, naming the 10 foods of 2024 that were subject to the most recalls and/or associated with the largest illness outbreaks. USA TODAY broke it down further on a what-you-need-to-know basis.
">Consumer Reports, the nonprofit known for testing and monitoring consumer-facing policy and products, released its annual risky food report in April, naming the 10 foods of 2024 that were subject to the most recalls and/or associated with the largest illness outbreaks. USA TODAY broke it down further on a what-you-need-to-know basis.
" src=https://s.yimg.com/ny/api/res/1.2/OIaDuBQk1nrNxd_YCJjDlQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTEyNDI7aD04NTE-/https://media.zenfs.com/en/usa_today_slideshows_242/ea62e25c5245aae282619b85b061ab5e class=caas-img>Boar's Head listeria outbreak that killed 10. Listeria monocytogenes is a hardy germ that can survive in very low temperatures but thrives in cool and damp places. It can, and will, happily live on foods in your or your grocery store's storage area, and the process for mass-producing the meat lends itself to plenty of opportunities for contamination.
" style=padding-bottom:56%>Deli meat is somewhat of a "risky" food as it is often associated with the spread of listeria, such as in the 2024 case of the Boar's Head listeria outbreak that killed 10. Listeria monocytogenes is a hardy germ that can survive in very low temperatures but thrives in cool and damp places. It can, and will, happily live on foods in your or your grocery store's storage area, and the process for mass-producing the meat lends itself to plenty of opportunities for contamination.
" data-src=https://s.yimg.com/ny/api/res/1.2/Pse0WA8WALsote64upvrcw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTEyNDI7aD04Mjg-/https://media.zenfs.com/en/usa_today_slideshows_242/9bfcc95c51e289d051769955c9ad2c03 class=caas-img data-headline="See the 'risky foods' linked to recent US recalls and illness outbreaks" data-caption="
Deli meat is somewhat of a "risky" food as it is often associated with the spread of listeria, such as in the 2024 case of the Boar's Head listeria outbreak that killed 10. Listeria monocytogenes is a hardy germ that can survive in very low temperatures but thrives in cool and damp places. It can, and will, happily live on foods in your or your grocery store's storage area, and the process for mass-producing the meat lends itself to plenty of opportunities for contamination.
">Deli meat is somewhat of a "risky" food as it is often associated with the spread of listeria, such as in the 2024 case of the Boar's Head listeria outbreak that killed 10. Listeria monocytogenes is a hardy germ that can survive in very low temperatures but thrives in cool and damp places. It can, and will, happily live on foods in your or your grocery store's storage area, and the process for mass-producing the meat lends itself to plenty of opportunities for contamination.
" src=https://s.yimg.com/ny/api/res/1.2/Pse0WA8WALsote64upvrcw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTEyNDI7aD04Mjg-/https://media.zenfs.com/en/usa_today_slideshows_242/9bfcc95c51e289d051769955c9ad2c03 class=caas-img>cucumbers recalled due to a salmonella outbreak that infected 113 people across 23 states, can become adulterated with E. coli through fecal contamination, which can occur through wastewater, water in the growing area, fertilizer and the proximity of the growing area to livestock.
" style=padding-bottom:56%>Produce, like the cucumbers recalled due to a salmonella outbreak that infected 113 people across 23 states, can become adulterated with E. coli through fecal contamination, which can occur through wastewater, water in the growing area, fertilizer and the proximity of the growing area to livestock.
" data-src=https://s.yimg.com/ny/api/res/1.2/O._5uEh50acHVuYWhyGlkg--/YXBwaWQ9aGlnaGxhbmRlcjt3PTEyNDI7aD04Mjg-/https://media.zenfs.com/en/usa_today_slideshows_242/f13472dedea06cffc47625696e01e3bf class=caas-img data-headline="See the 'risky foods' linked to recent US recalls and illness outbreaks" data-caption="
Produce, like the cucumbers recalled due to a salmonella outbreak that infected 113 people across 23 states, can become adulterated with E. coli through fecal contamination, which can occur through wastewater, water in the growing area, fertilizer and the proximity of the growing area to livestock.
">Produce, like the cucumbers recalled due to a salmonella outbreak that infected 113 people across 23 states, can become adulterated with E. coli through fecal contamination, which can occur through wastewater, water in the growing area, fertilizer and the proximity of the growing area to livestock.
" src=https://s.yimg.com/ny/api/res/1.2/O._5uEh50acHVuYWhyGlkg--/YXBwaWQ9aGlnaGxhbmRlcjt3PTEyNDI7aD04Mjg-/https://media.zenfs.com/en/usa_today_slideshows_242/f13472dedea06cffc47625696e01e3bf class=caas-img>Raw dairy, which is always unsafe to consume and illegal to sell in some states, poses a risk when it's not pasteurized. Dairy pasteurization, or heating milk products to a high enough temperature to kill harmful bacteria, has been practiced since the 1920s and has resulted in illnesses commonly spread via milk, such as listeriosis, diphtheria and tuberculosis, becoming less prevalent.
" data-src=https://s.yimg.com/ny/api/res/1.2/dbzc2mG5oqPJ8KwZGtE.HQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTEyNDI7aD04Mjg-/https://media.zenfs.com/en/usa_today_slideshows_242/c33fdf952701e2d3b07e54b9d53b65dd class=caas-img data-headline="See the 'risky foods' linked to recent US recalls and illness outbreaks" data-caption="
Raw dairy, which is always unsafe to consume and illegal to sell in some states, poses a risk when it's not pasteurized. Dairy pasteurization, or heating milk products to a high enough temperature to kill harmful bacteria, has been practiced since the 1920s and has resulted in illnesses commonly spread via milk, such as listeriosis, diphtheria and tuberculosis, becoming less prevalent.
">Raw dairy, which is always unsafe to consume and illegal to sell in some states, poses a risk when it's not pasteurized. Dairy pasteurization, or heating milk products to a high enough temperature to kill harmful bacteria, has been practiced since the 1920s and has resulted in illnesses commonly spread via milk, such as listeriosis, diphtheria and tuberculosis, becoming less prevalent.
" src=https://s.yimg.com/ny/api/res/1.2/dbzc2mG5oqPJ8KwZGtE.HQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTEyNDI7aD04Mjg-/https://media.zenfs.com/en/usa_today_slideshows_242/c33fdf952701e2d3b07e54b9d53b65dd class=caas-img>Rizo-Lopez Foods, was shut down in October 2024 after its cheeses were linked to a years-long listeria outbreak that killed two people and made dozens of others sick.
" style=padding-bottom:56%>Cotija and queso fresco cheese are made from unpasteurized milk, meaning they carry an increased risk. One producer, Rizo-Lopez Foods, was shut down in October 2024 after its cheeses were linked to a years-long listeria outbreak that killed two people and made dozens of others sick.
" data-src=https://s.yimg.com/ny/api/res/1.2/IMBEVbqmJKn.hFWVXkgVMw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTEyNDI7aD04Mjg-/https://media.zenfs.com/en/usa_today_slideshows_242/83ecd4edb909f0cbaecd8d647d00d067 class=caas-img data-headline="See the 'risky foods' linked to recent US recalls and illness outbreaks" data-caption="
Cotija and queso fresco cheese are made from unpasteurized milk, meaning they carry an increased risk. One producer, Rizo-Lopez Foods, was shut down in October 2024 after its cheeses were linked to a years-long listeria outbreak that killed two people and made dozens of others sick.
">Cotija and queso fresco cheese are made from unpasteurized milk, meaning they carry an increased risk. One producer, Rizo-Lopez Foods, was shut down in October 2024 after its cheeses were linked to a years-long listeria outbreak that killed two people and made dozens of others sick.
" src=https://s.yimg.com/ny/api/res/1.2/IMBEVbqmJKn.hFWVXkgVMw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTEyNDI7aD04Mjg-/https://media.zenfs.com/en/usa_today_slideshows_242/83ecd4edb909f0cbaecd8d647d00d067 class=caas-img>Eggs can become contaminated via the same means as cucumbers and other raw produce, especially if they have a cracked shell.
" data-src=https://s.yimg.com/ny/api/res/1.2/pu1HEbUS9ofL55HdiAr2wQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTEyNDI7aD04Mjg-/https://media.zenfs.com/en/usa_today_slideshows_242/f79fcd18fa33c0675d8b2078d0bdbeb6 class=caas-img data-headline="See the 'risky foods' linked to recent US recalls and illness outbreaks" data-caption="
Eggs can become contaminated via the same means as cucumbers and other raw produce, especially if they have a cracked shell.
">Eggs can become contaminated via the same means as cucumbers and other raw produce, especially if they have a cracked shell.
" src=https://s.yimg.com/ny/api/res/1.2/pu1HEbUS9ofL55HdiAr2wQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTEyNDI7aD04Mjg-/https://media.zenfs.com/en/usa_today_slideshows_242/f79fcd18fa33c0675d8b2078d0bdbeb6 class=caas-img>McDonald's Quarter Pounders triggered some locations to stop serving the burger temporarily.
" style=padding-bottom:56%>Like other raw produce, onions can become infected via fecal contamination. In 2024, E. coli-contaminated slivered onions on McDonald's Quarter Pounders triggered some locations to stop serving the burger temporarily.
" data-src=https://s.yimg.com/ny/api/res/1.2/EiiAnsMZpPgnzw_QD2dFAA--/YXBwaWQ9aGlnaGxhbmRlcjt3PTEyNDI7aD04MjI-/https://media.zenfs.com/en/usa_today_slideshows_242/a375b05e367252f33d058cebdc891644 class=caas-img data-headline="See the 'risky foods' linked to recent US recalls and illness outbreaks" data-caption="
Like other raw produce, onions can become infected via fecal contamination. In 2024, E. coli-contaminated slivered onions on McDonald's Quarter Pounders triggered some locations to stop serving the burger temporarily.
">Like other raw produce, onions can become infected via fecal contamination. In 2024, E. coli-contaminated slivered onions on McDonald's Quarter Pounders triggered some locations to stop serving the burger temporarily.
" src=https://s.yimg.com/ny/api/res/1.2/EiiAnsMZpPgnzw_QD2dFAA--/YXBwaWQ9aGlnaGxhbmRlcjt3PTEyNDI7aD04MjI-/https://media.zenfs.com/en/usa_today_slideshows_242/a375b05e367252f33d058cebdc891644 class=caas-img>Solata Foods spinach recall in 2024.
" style=padding-bottom:56%>Like cucumbers and onions, leafy greens are easily contaminated with bacteria like E. coli, as in the case of the Solata Foods spinach recall in 2024.
" data-src=https://s.yimg.com/ny/api/res/1.2/DVDkWPfQr9FG_29NIGPcrw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTEyNDI7aD04Mjg-/https://media.zenfs.com/en/usa_today_slideshows_242/a75cb0fb08b030fe9352c293072ef802 class=caas-img data-headline="See the 'risky foods' linked to recent US recalls and illness outbreaks" data-caption="
Like cucumbers and onions, leafy greens are easily contaminated with bacteria like E. coli, as in the case of the Solata Foods spinach recall in 2024.
">Like cucumbers and onions, leafy greens are easily contaminated with bacteria like E. coli, as in the case of the Solata Foods spinach recall in 2024.
" src=https://s.yimg.com/ny/api/res/1.2/DVDkWPfQr9FG_29NIGPcrw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTEyNDI7aD04Mjg-/https://media.zenfs.com/en/usa_today_slideshows_242/a75cb0fb08b030fe9352c293072ef802 class=caas-img>major E. coli outbreak in late 2024, leaving at least 39 ill and one dead.
" style=padding-bottom:56%>Organic carrots were linked to a major E. coli outbreak in late 2024, leaving at least 39 ill and one dead.
" data-src=https://s.yimg.com/ny/api/res/1.2/yPhlEWaQOjK0vqaHjj4XMw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTEyNDI7aD04Mjg-/https://media.zenfs.com/en/usa_today_slideshows_242/155d1bb268cb1031536f42b68cc575d7 class=caas-img data-headline="See the 'risky foods' linked to recent US recalls and illness outbreaks" data-caption="
Organic carrots were linked to a major E. coli outbreak in late 2024, leaving at least 39 ill and one dead.
">Organic carrots were linked to a major E. coli outbreak in late 2024, leaving at least 39 ill and one dead.
" src=https://s.yimg.com/ny/api/res/1.2/yPhlEWaQOjK0vqaHjj4XMw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTEyNDI7aD04Mjg-/https://media.zenfs.com/en/usa_today_slideshows_242/155d1bb268cb1031536f42b68cc575d7 class=caas-img>millions of pounds of RTE foods were recalled by BrucePac for listeria contamination.
" style=padding-bottom:56%>Ready-to-eat/cooked poultry and meat have been the source of multiple major recalls and foodborne illness outbreaks in recent years. The same issue arises with RTE foods as with deli meat; the conditions they are made and stored under are often ideal for bacteria such as listeria to grow. In 2024, millions of pounds of RTE foods were recalled by BrucePac for listeria contamination.
" data-src=https://s.yimg.com/ny/api/res/1.2/.QE9kd8WKUQOlA17jrDojw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTEyNDI7aD05MzI-/https://media.zenfs.com/en/usa_today_slideshows_242/a819b16c2046400d4daad3c994cd1d67 class=caas-img data-headline="See the 'risky foods' linked to recent US recalls and illness outbreaks" data-caption="
Ready-to-eat/cooked poultry and meat have been the source of multiple major recalls and foodborne illness outbreaks in recent years. The same issue arises with RTE foods as with deli meat; the conditions they are made and stored under are often ideal for bacteria such as listeria to grow. In 2024, millions of pounds of RTE foods were recalled by BrucePac for listeria contamination.
">Ready-to-eat/cooked poultry and meat have been the source of multiple major recalls and foodborne illness outbreaks in recent years. The same issue arises with RTE foods as with deli meat; the conditions they are made and stored under are often ideal for bacteria such as listeria to grow. In 2024, millions of pounds of RTE foods were recalled by BrucePac for listeria contamination.
" src=https://s.yimg.com/ny/api/res/1.2/.QE9kd8WKUQOlA17jrDojw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTEyNDI7aD05MzI-/https://media.zenfs.com/en/usa_today_slideshows_242/a819b16c2046400d4daad3c994cd1d67 class=caas-img>
1 / 10See the 'risky foods' linked to recent US recalls and illness outbreaks
Consumer Reports, the nonprofit known for testing and monitoring consumer-facing policy and products, released its annual risky food report in April, naming the 10 foods of 2024 that were subject to the most recalls and/or associated with the largest illness outbreaks. USA TODAY broke it down further on a what-you-need-to-know basis.
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."
Pictured is ByHeart Whole Nutrition Infant Baby FormulaBaby 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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