Ashley Rodolph, a 26-year-old mother living in Texas, began purchasing ByHeart infant formula because she believed it was a safer, cleaner alternative to other baby products on the market.
But that assumption changed dramatically this month. Rodolph learned that ByHeart was recalling its powdered formula because it is likely linked to an outbreak of infant botulism that has sickened more than a dozen babies. She panicked, hoping the formula she had been giving her daughter for the past three months wasn’t from a defective can.
“I don’t know if we’ve had those cans or not, and it was pretty scary to think about,” he said in a phone interview Friday. “When you feed your baby formula, you don’t think about saving the cans in case they go off the market.”
Rodolph and her husband stopped using the formula on Nov. 9, a day after the product was pulled from store shelves and online merchants amid a Food and Drug Administration investigation. The family pediatrician has advised him to monitor his daughter Saphira for the onset of symptoms.
“You look at your baby and see that he’s totally fine, and then you wonder: What if he’s not? What if he’s showing symptoms and I just don’t know what they are? What if he’s not fine tomorrow?” Rudolph said. “It’s an absolutely terrifying situation.”
Rodolph is one of many parents across the country who are deeply shocked by the botulism outbreak. As of Friday, 23 cases had been reported in 13 states, according to the FDA. To date, no deaths have been reported, the agency said.
In a fact sheet, the FDA said most children with infant botulism will initially develop constipation, poor feeding, loss of head control and difficulty swallowing. Symptoms may worsen: difficulty breathing, respiratory arrest.
Symptoms take up to several weeks to appear, the FDA said. If left untreated, the infection can lead to paralysis and death, according to the Centers for Disease Control and Prevention.
ByHeart originally said it was recalling two lots of Whole Nutrition organic infant formula after the FDA announced it was investigating the outbreak’s links to the product. ByHeart then expanded the recall last week to include all batches of the formula.
“The safety and well-being of every baby who uses our formula is, and always will be, our top priority,” ByHeart co-founder and president Mia Funt said in a statement.
“This nationwide recall reflects our commitment to protecting babies and providing families with clear, actionable information. In addition to this recall, we are conducting comprehensive research to do our part and get the answers parents expect and deserve.”
Summer Besecke, a 25-year-old mother from Longview, Texas, said she was feeding her son Syrus when she learned via email that the formula she was using had been recalled.
“I took the bottle out of his mouth and started crying,” Besecke said. “At first I didn’t know what botulism was, so I got worried and my heart sank.” He went online and did some research. “Instead of my heart dropping, it was more like a burning hole in my chest because I’m literally actively feeding my son this.”
Besecke then noticed worrying symptoms. The 6-week-old baby suffered from constipation. He had trouble lifting his head. He was “a little limper than usual,” he said.
Syrus spent two days in the hospital before being released Thursday, according to his mother. Besecke and her husband are now awaiting test results to determine if their son has botulism.
“There has been a lot of concern,” he said. “I’m supposed to cherish these moments, and that was stolen from me.”
ByHeart faces at least two lawsuits from parents who say their babies became sick and allege the company was negligent in selling “defective” formula. Families seek financial compensation for medical bills, emotional distress and other damages.
Yurany and Stephen Dexter of Arizona, the plaintiffs behind one of the lawsuits, said their 4-month-old daughter, Rose, started looking sick in August. She seemed weak and listless, with her eyelids half open.
“I just remember her lying there with her arms crossed over her chest, very quiet, refusing the bottle,” Stephen Dexter said in an interview.
The lawsuit says Rose ultimately had to be flown by air ambulance to a children’s hospital in Phoenix, two hours from her home in Flagstaff. She was treated there for about two weeks, her father said.
The Dexters believe ByHeart should face the consequences.
“You have chosen to be in a position of offering a product that is marketed directly toward a group of people who, by definition, are helpless,” Stephen Dexter said. “If you’re not doing 110% to make sure the product you’re selling is absolutely pure, then we have a problem.”
