In a crisis that has shaken parents and health officials alike, the recall of ByHeart Whole Nutrition Infant Formula has sent waves of concern across the United States and beyond. The recall, which began in early November 2025, was triggered by an outbreak of infant botulism—a rare but potentially deadly illness—linked to the formula. As of late November, at least 31 infants across 15 states have been hospitalized, with the youngest patients just 16 days old, according to the U.S. Centers for Disease Control and Prevention (CDC).
The initial recall, announced by the Food and Drug Administration (FDA) on November 8, 2025, targeted two specific batches of ByHeart formula. But as more cases emerged, the scope widened dramatically. By November 11, ByHeart expanded the recall to include all lots of its Whole Nutrition Infant Formula sold by major retailers such as Walmart, Publix, Meijer, Kroger, and Amazon. The FDA underscored the urgency, stating, “Epidemiologic and laboratory data show that ByHeart Whole Nutrition infant formula might be contaminated with Clostridium botulinum, [the bacteria that causes botulism] which is causing infant illness in multiple regions of the country.”
Despite these sweeping measures, reports surfaced that the recalled formula was still being found on store shelves in multiple states—including at Walmart, Target, Kroger, Sprouts Organic Market, Safeway, Jewel-Osco, Shaw’s, and Star Market. The FDA noted that through Amazon sales, the formula had reached countries as far-flung as Argentina, Brazil, China, Israel, and South Africa, raising global concerns about the outbreak’s reach.
ByHeart, for its part, has been vocal about its response. In a statement on its website, the company said, “We are working to investigate the facts, conduct ongoing testing to identify the source, and ensure this does not happen to families again. We continue to urge parents and caregivers to stop using ByHeart formula immediately, monitor your child for symptoms of infant botulism, and seek medical care immediately if they develop symptoms.” The company also admitted, “We have just learned that those tests identified Clostridium botulinum in some samples of ByHeart formula. We immediately notified the FDA of those findings, and we are working to investigate the facts, conduct ongoing testing to identify the source, and ensure this does not happen to families again.”
Symptoms of infant botulism can be subtle at first—constipation, poor feeding, a weak or altered cry, and loss of head control—but can quickly escalate to “progressive, flaccid paralysis” requiring weeks of hospitalization and even respiratory support, the CDC warns. The agency recommends that parents take photos or record information from the bottom of any ByHeart formula package, label containers as ‘DO NOT USE,’ and keep them for possible testing if symptoms develop. If no symptoms arise after 30 days, the CDC says it is safe to discard the containers.
The outbreak’s impact has been keenly felt in Texas, which leads the nation with six reported cases, followed by California (four), Arizona and Oregon (three each), and several other states with one or two cases apiece. The affected infants are all under a year old, with some as young as just over two weeks. Kentucky mom Hanna Everett, whose four-month-old daughter Piper was hospitalized, told People, “She went through so much at such a young age and all we can hope is that it doesn’t follow her through life.” Everett added, “She is going to need speech and feeding therapy, so [we] are hoping that goes well and helps her. Other than struggling with her bottles and being exhausted, she’s mainly back to her normal, happy self, thank God.”
Adding to the sense of alarm are revelations that cases of infant botulism linked to ByHeart formula may have been occurring months before the current outbreak. California public health officials confirmed that six babies in the state were treated for botulism between November 2024 and June 2025 after consuming ByHeart formula—long before the surge of cases that began in August 2025. Parents like Amy Mazziotti and Katie Connolly, whose children fell ill in March and April 2025, are demanding answers. “What I want to know is why did the cases beginning in August flag an investigation, but the cases that began in March did not?” Connolly told the Associated Press.
Health officials say that linking earlier cases to the current outbreak is challenging, as parents may not have kept lot numbers or packaging from the formula cans. Dr. Jennifer Cope, a CDC scientist leading the investigation, explained, “Because so much time has passed and because parents of babies who got sick earlier may not have recorded lot numbers of product or kept empty cans of formula, it will make it harder to definitively link them to the outbreak.” Nevertheless, outside experts argue that any case involving ByHeart formula and infant botulism should be included in the investigation. “Absolutely, yes, they should be included,” Frank Yiannas, former deputy commissioner for food policy and response at the FDA, told the Associated Press.
ByHeart’s history with formula recalls adds another layer of complexity. In 2022, the company recalled five batches of Whole Nutrition Infant Formula over concerns of cronobacter contamination, a different but serious bacterial risk. Now, with Clostridium botulinum confirmed in some unopened cans, parents and advocates are questioning the adequacy of safeguards in the infant formula industry.
Legal action is already underway. At least three lawsuits have been filed against ByHeart on behalf of families from Washington, Kentucky, and Arizona, seeking accountability and answers. Food safety advocates like Sandra Eskin, chief executive of STOP Foodborne Illness, emphasize the trauma for families. “This outbreak is traumatic for parents,” Eskin said. “They may have fed their newborns and infants a product they assumed was safe. And now they’re dealing with hospitalization and serious illness of their babies.”
Infant botulism remains rare—fewer than 200 cases are reported annually in the U.S.—but its severity cannot be overstated. The disease is caused when babies ingest spores that germinate in the gut and release a toxin, leading to potentially life-threatening paralysis. The California Infant Botulism Treatment and Prevention Program tracks cases and distributes BabyBIG, the only approved treatment, an intravenous medication that can shorten the course of illness.
As the investigation continues, parents, health officials, and consumer advocates are united in their call for transparency and action. ByHeart has pledged, “We do not yet know the root cause, but we are committed to finding the answers. We are doing everything we can to ensure this investigation reveals solutions and aids in understanding cases of infant botulism broadly. That’s what parents, the medical community, and you deserve.”
For families affected by the outbreak, the search for answers is deeply personal—and ongoing. Their stories and demands for accountability are a sobering reminder of the stakes when it comes to infant health and food safety.
