Parents of babies who became severely ill after consuming a formula suspected of being contaminated with a toxin have spoken out about their ordeals in a bid to warn others about the issue blighting families nationwide.
New York City-based ByHeart initiated a voluntary recall on November 8 for two specific lots of its Whole Nutrition Infant Formula after the FDA alerted the company to an ongoing botulism investigation.
Then, on November 11, the company expanded the recall to all batches of its Whole Nutrition Infant Formula.
Preliminary testing by the California Department of Public Health found Clostridium botulinum spores in an opened can of ByHeart formula that had been consumed by a sick infant.
Later, ByHeart said independent third-party lab tests detected C. botulinum in some unopened cans, and the company reported that to the FDA. The FDA reports that as of November 19, there have been 31 cases of infant botulism linked to recall in 15 states.
Since then, a growing number of families across the US have filed lawsuits against ByHeart, Inc., alleging that the company’s infant formula caused severe cases of infant botulism now tied to a nationwide outbreak.
At least three new lawsuits, filed in Arizona, California, and Washington, detail similar medical emergencies: previously healthy infants who suddenly developed weakness, feeding difficulties, and life-threatening neurological symptoms after consuming ByHeart formula.
One of those lawsuits is from Stephen and Yurany Dexter in Arizona, who allege their daughter, referred to as E.D. in court documents, contracted botulism after consuming ByHeart formula used to supplement breast milk.
In Arizona, Stephen and Yurany Dexter filed a federal lawsuit alleging their daughter (pictured), referred to as E.D. in court documents, contracted botulism after consuming ByHeart formula used to supplement breast milk
ByHeart, which has initiated a voluntary recall, has said publicly that the situation is ‘heartbreaking’ and that the company is working to support concerned families
E.D. was born on July 5, 2025, and initially thrived. But on August 21, her parents said in the lawsuit they noticed troubling symptoms: stomach discomfort, gas, and a steadily decreasing appetite.
In the suit, they claim that within a week, she refused to eat, even when fed by syringe. She soon lost the ability to suck, swallow, cry with normal strength, or hold her head up. Her parents feared she would die.
Physicians at Phoenix Children’s Hospital initially suspected muscular dystrophy because infant botulism is so rare, with only around 100 cases in the US per year.
But as her condition worsened, E.D. was given BabyBIG antitoxin, the only treatment available for botulism, and began intensive occupational, physical, and speech therapy.
She was eventually discharged with an IV feeding tube and her parents claim she continues to struggle with digestive and strength issues, according to the lawsuit.
The long-term effects remain unknown, but children who fail to thrive early in life or struggle to eat can face several well-documented medical complications, including delayed growth, poor weight gain, nutritional deficiencies and, in more prolonged cases, neurodevelopmental delays tied to insufficient calories during critical periods of brain development.
The lawsuit also claims the trauma has left E.D. with separation anxiety requiring constant caregiver contact.
The filings state that eventually doctors discovered E.D. had infantile botulism, but they don’t specify whether that was via toxin detection in stool, a blood test, or another method.
Attorneys with Marler Clark, The Food Safety Law Firm, along with regional co-counsel, represent many of the affected families.
Lead attorney Bill Marler said told Daily Mail he has now been retained ‘by over a dozen families whose kids are part of this outbreak,’ adding that he expects more cases to surface.
ByHeart has said publicly that the situation is ‘heartbreaking’ and that the company is working to support concerned families.
In a statement to Daily Mail, responding to the allegations set forth by the families’ lawsuits, ByHeart said: ‘The safety and well-being of babies, and the trust families have placed in us, are our highest priorities. We partnered with an independent lab to test cans of ByHeart formula and that lab has identified Clostridium botulinum in some samples of our formula.
‘We recognize this news is heartbreaking for parents and we are committed to working with speed and transparency to provide continued support for our community and ensure this investigation leads to solutions for our processes and the industry at-large.
In Washington state, Madison and Tyler Wescott of Eatonville filed suit in federal court after their infant daughter (pictured) was hospitalized with confirmed botulism earlier this month
‘We have been working in cooperation with the FDA, and we are investigating every facet of our process. All findings will be shared transparently with regulators and industry partners to strengthen safeguards and ensure this never happens again.
‘Until now, this bacterium was not among the pathogens routinely tested for across the industry, despite thousands of safety tests conducted by all manufacturers.
‘As a result, we are also working with the FDA to understand how Clostridium botulinum entered the food supply to help advance testing standards and ensure the highest level of safety for families.’
A lawsuit filed in California centers on the case of A.B., born September 29, 2025, in Stockton.
His parents, Anthony Barbera and Thalia Flores, fed him ByHeart formula exclusively beginning in early October, using sterilized bottles and distilled water.
According to the lawsuit, A.B. was healthy at a pediatric visit on October 22. But within 48 hours, he began eating less, crying weakly, and producing fewer wet diapers.
On October 25, his parents rushed him to St. Joseph’s Medical Center, where physicians documented dehydration, a weak cry, inability to latch, and worsening lethargy, the lawsuit claims. His decline was so sharp that he was admitted to the neonatal intensive care unit.
Doctors observed near-total loss of strength: A.B. could barely open his eyes, could not hold up his head, offered only faint moans, and showed severe weakness in all extremities.
ByHeart, a manufacturer of organic baby formula that is being recalled, is displayed outside a building that houses a plant for the company
Confronted with possible diagnoses ranging from botulism to spinal muscular atrophy, the medical team consulted the California Department of Public Health’s Infant Botulism Treatment and Prevention Program, which recommended immediate BabyBIG antitoxin.
By late October, a stool sample confirmed botulism type A. Public health officials collected the family’s open cans of ByHeart formula for testing.
Although A.B. gradually improved, he remained hospitalized until early November.
Today, the complaint says, he continues to struggle with constipation and slow feeding. His parents say the ordeal ‘shattered the trust’ they placed in ByHeart, adding: ‘We believed we were making a well-informed choice… Instead, we feel like we inadvertently participated in the poisoning of our baby.’
In Washington state, Madison and Tyler Wescott of Eatonville filed suit in federal court after their infant daughter, who was fed ByHeart formula, was hospitalized with confirmed botulism earlier this month.
The child, born in September, began showing symptoms in early November, difficulty feeding, choking, spilling milk from her mouth, constipation requiring suppositories, and extreme fatigue, according to the complaint. On November 13, she was taken to an emergency room.
The Wescotts had just learned of the ByHeart recall through a notice from a retailer. After consultation with the CDC and local health authorities, physicians treated the child for botulism and admitted her to the pediatric unit. She remained hospitalized until November 19.
As of mid-November, the outbreak includes at least 31 infants in 15 states with suspected or confirmed botulism. No deaths have been reported
Health officials in Washington have since urged parents to immediately stop using ByHeart Whole Nutrition Infant Formula. As of mid-November, the outbreak includes at least 31 infants in 15 states with suspected or confirmed botulism. No deaths have been reported.
With lawsuits now filed in multiple states, and more under investigation, the ByHeart outbreak has quickly become one of the most significant infant food-safety crises in recent memory.
Marler, who has previously represented victims in major foodborne illness outbreaks, said he is also reviewing earlier 2025 cases of infant botulism. where infants consumed ByHeart.
‘My fear is that we will see these numbers go up,’ he told Daily Mail.
ByHeart maintains that it is cooperating with investigators and has set up 24/7 support channels for concerned families. Federal health agencies continue testing, and more case confirmations are expected.
Infant botulism is a rare but potentially fatal condition that affects babies, usually under 12 months old.
Another lawsuit filed in California centers on the case of A.B., pictured. His parents, Anthony Barbera and Thalia Flores, fed him ByHeart formula exclusively beginning in early October
In the US, there are typically about 100–200 total botulism cases reported each year, depending on the year.
The majority of these, usually around two-thirds, are infant botulism cases, affecting babies under one year old.
It happens when spores of the bacterium Clostridium botulinum enter an infant’s intestines, where they can grow and produce botulinum toxin – one of the most potent natural toxins known.
Symptoms can include constipation, poor feeding, drooping eyelids, weak cry, low muscle tone, and in severe cases, respiratory difficulty or arrest.
In infant botulism, the food doesn’t contain toxin; it contains spores that have the potential to produce toxin inside the baby’s body.
The best-known food linked to infant botulism is honey, and health authorities advise never giving honey to babies under 12 months.
Occasionally, spores can also be found in dusty home environments, unwashed produce, or powdered foods, though these are much rarer routes of exposure.
The main treatment for infant botulism is an antitoxin called Botulism Immune Globulin Intravenous (Human), or BIG-IV, administered via a single intravenous infusion.
Supportive care is also essential, which may include hospitalization, breathing support with a ventilator if needed, and IV fluids or tube feedings to maintain nutrition if the infant has difficulty swallowing.
Early diagnosis and treatment are crucial for a favorable outcome.
While death is rare at less than one percent, recovery can be a lengthy process, requiring months or even years for full recovery.
