Parents in Arizona and Kentucky have filed federal lawsuits against ByHeart, the manufacturer of a recently recalled infant formula, after their 4-month-old daughters developed infantile botulism. The families allege the product was defective and say the company failed to protect consumers from potential contamination.
Stephen and Yurany Dexter of Flagstaff, Arizona, and Michael and Hanna Everett of Richmond, Kentucky, describe sudden and severe illnesses that required their infants, Rose and Piper, to receive intensive hospital care. Both families are seeking compensation for medical costs, emotional distress, and related losses.
“I wouldn’t guess that a product designed for a helpless, developing human… could cause something this severe,” said Stephen Dexter. Hanna Everett recalled watching her daughter’s rapid decline: “She’s so little and you’re just helplessly watching this.”
National Outbreak and Ongoing Investigations
The two infants are among at least 15 children across a dozen states affected in an infantile botulism outbreak that began in August, according to federal and state health officials. No deaths have been reported.
Infantile botulism is a rare but potentially life-threatening condition caused by ingestion of Clostridium botulinum spores, which can produce toxins in the immature gut. Early symptoms may be subtle, and onset can take up to 30 days after exposure.
Health officials report that at least 84 U.S. infants have been treated for infantile botulism since August, including cases not yet confirmed to be part of the outbreak. The spike in investigations followed ByHeart’s nationwide recall of all its infant formula products. One open can of formula associated with an ill child tested positive for bacteria capable of causing botulism, California officials said.
ByHeart, a New York–based company that sells roughly 200,000 cans of formula each month, stated it is focused on keeping families informed about the recall. Company representatives did not comment directly on the lawsuits but said legal claims would be addressed in due course.
Food-safety attorney Bill Marler, who represents the Dexters, said these could be the first of many legal actions. “This company potentially faces an existential crisis,” he said.
Families Describe Rapidly Escalating Symptoms
Both families said they chose ByHeart’s organic formula because they believed it was a healthier alternative. Rose Dexter received the formula within days of her July birth to supplement limited breast milk. Her parents noticed ongoing feeding difficulties and increasing lethargy. On Aug. 31, at 8 weeks old, she became unresponsive and was transported by air ambulance to Phoenix Children’s Hospital, where she remained for nearly two weeks.
Piper Everett began showing signs of illness in early November. After learning about ByHeart’s recall, her family discovered that the empty cans at home matched the recalled lots. She was admitted to Kentucky Children’s Hospital with rapidly worsening neurological symptoms—including poor pupil response, loss of her gag reflex, and profound muscle weakness—which required a feeding tube and IV support.
Treatment and Recovery
Both infants received BabyBIG, an intravenous antitoxin made from the plasma of donors immunized against botulinum neurotoxins. It is the only treatment available for infants under one year of age.
Following treatment, the babies gradually improved. Rose no longer needs a feeding tube and returned home in September. Piper was discharged this week. Their parents report they are doing well on different formulas.
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