When Stephen and Yurany Dexter’s 4-month-old daughter, Rose, suddenly became unresponsive in late August, their world turned upside down. The Dexters, residents of Flagstaff, Arizona, had chosen ByHeart baby formula for its organic promise, hoping to give their newborn the healthiest start. Instead, they found themselves watching helplessly as Rose was airlifted to Phoenix Children’s Hospital, where she spent nearly two weeks battling the rare and potentially deadly illness known as infantile botulism. “I wouldn’t guess that a product designed for a helpless, developing human in the United States could cause something this severe,” Stephen Dexter told reporters, still reeling from the ordeal.
Rose’s story is not unique. Michael and Hanna Everett of Richmond, Kentucky, faced a similar nightmare just weeks later. Their daughter Piper, also four months old, was rushed to Kentucky Children’s Hospital on November 8, 2025, after displaying alarming symptoms: muscle weakness, limp arms, and a loss of her gag reflex. “She’s so little and you’re just helplessly watching this,” Hanna Everett said, recalling the terror of those days. Both infants were ultimately diagnosed with infantile botulism, a condition that can cause muscle paralysis and, without prompt treatment, even death.
According to federal and state health officials, at least 23 infants in a dozen states have been sickened in a botulism outbreak that began in August 2025, all linked to powdered formula from ByHeart, a New York-based company that touts its product as a natural, healthier alternative. The outbreak’s impact has been significant, but no deaths have been reported. Both Rose and Piper received BabyBIG, an intravenous medication derived from blood plasma of immunized donors—the only approved treatment for infantile botulism in children under one year old. The medication had to be shipped from California, and in the meantime, both girls required feeding tubes and intensive supportive care. Thankfully, both children have since recovered and are thriving on different formulas.
The parents’ anguish has now turned to legal action. On November 13, 2025, the Dexter and Everett families filed lawsuits in federal courts, alleging that ByHeart’s formula was defective and that the company was negligent in its manufacturing and safety practices. The lawsuits seek compensation for medical bills, emotional distress, and other damages. “This company potentially faces an existential crisis,” Bill Marler, a prominent Seattle food safety lawyer representing the Dexters, told the press. ByHeart, for its part, has promised to “address any legal claims in due course” and emphasized its focus on ensuring families are aware of the recall and necessary safety steps.
The scope of the outbreak is sobering. California officials confirmed that a sample from an open can of ByHeart formula fed to an ill infant contained the bacteria responsible for botulism. At least 84 U.S. babies have been treated for infantile botulism since August, including those in this outbreak. The company, which sells about 200,000 cans of formula per month and holds roughly 1 percent of the U.S. infant formula market, issued a nationwide recall for all its products on November 11, 2025. Initially, ByHeart recalled only two batches, but after mounting evidence and pressure, it expanded the recall to include all lots.
For many parents, the recall came too late. On ByHeart’s Facebook page, frustration and fear are palpable. One mother wrote, “I have yet to sleep in peace since we heard about this,” echoing the distress of countless families who believed they were giving their babies the best. Others lamented having to discard expensive formula—ByHeart’s product retailed at about $1.75 per ounce, notably higher than competitors like Abbott’s Similac Advance.
The ByHeart outbreak is the latest in a troubling series of food safety lapses in the U.S. infant formula industry. Just three years ago, Abbott Laboratories, which produces about 40 percent of the nation’s formula, recalled its products after two children died from Cronobacter, a different bacterial infection. That recall triggered a months-long nationwide shortage, exacerbated by pandemic-era supply chain woes. Although Abbott’s Michigan factory was suspected as the source, the company denied responsibility, and a definitive link was never established. Nevertheless, the incident led to congressional hearings and promises from the Food and Drug Administration (FDA) to tighten oversight of formula manufacturers.
Despite these assurances, the current ByHeart crisis suggests that vulnerabilities remain. The FDA inspects infant-formula plants at least once a year, a more frequent schedule than for most other high-risk foods. Yet, in February 2025, inspectors found manufacturing deficiencies at ByHeart’s Iowa facility—one of two linked to the outbreak. The specifics of those deficiencies remain undisclosed, but the FDA previously issued a formal warning letter to ByHeart in 2023 after finding mold and thousands of dead insects at its since-closed Reading, Pennsylvania, plant. ByHeart says those issues have been resolved, but food safety experts remain skeptical.
“There’s a lot of red flags about the way ByHeart is managing this outbreak, which tells me they don’t have an experienced food-safety team at the helm,” Sarah Sorscher, director of regulatory affairs at the Center for Science in the Public Interest, told reporters. The company has questioned the methodology of the California Department of Public Health, which found the botulism-causing bacteria in an open canister of its formula, and maintained that “there is no confirmed link between ByHeart’s infant formula and infant botulism.” In an open letter, ByHeart also noted that formula makers are not required by law to test for the bacteria responsible for infant botulism—a defense that Frank Yiannas, a former FDA deputy commissioner, called “not a really good answer.” He argued that companies, especially those making infant formula, should proactively analyze hazards and risks, regardless of regulatory requirements.
Food safety advocates like Sandra Eskin, CEO of Stop Foodborne Illness, stress that ultimate responsibility rests with manufacturers: “It is the responsibility of a food company, whether they’re making baby formula or Pop-Tarts or selling romaine, to ensure that their food is safe.” But regulators are not off the hook. In the 2021–22 Abbott outbreak, the FDA failed to follow up on a whistleblower’s complaints for over a year, a delay that drew sharp criticism and raised questions about the agency’s effectiveness.
Infant botulism remains a rare disease, with just 181 cases confirmed in the United States in 2021. The medical literature documents only a handful of cases previously linked to infant formula. Still, the recent surge—nearly two dozen cases tied to one brand in a matter of months—has rattled parents and experts alike. While ByHeart operates its own manufacturing facilities, unlike many smaller brands that use third-party contractors, this outbreak appears contained to its products. Its limited market share has helped avoid a nationwide shortage, but the reputational damage may be lasting.
As investigations continue, families like the Dexters and Everetts are left to pick up the pieces. Both Rose and Piper are doing well on new formulas, but the trauma lingers. The ByHeart case is a stark reminder that even in industries thought to be bulletproof, a single lapse can have profound consequences for the most vulnerable among us.
