As parents across the United States and Canada grapple with growing concerns over the safety of infant formula, the ByHeart baby formula recall has sent shockwaves through families, health officials, and retailers alike. The crisis, which began to unfold publicly in November 2025, has now been linked to more than 30 cases of infant botulism in the U.S., and has prompted a sweeping recall and urgent warnings on both sides of the border. Behind the headlines, however, are stories of anxious parents, bureaucratic delays, and lingering questions about how a trusted baby product could become the source of such a rare and dangerous illness.
According to The Associated Press, California public health officials confirmed that six babies in the state who consumed ByHeart formula were treated for botulism between November 2024 and June 2025, as much as nine months before the outbreak that triggered the current national alarm. "At the time, there was 'not enough evidence to immediately suspect a common source,'" the California Department of Public Health said. Even now, officials maintain, "we cannot connect any pre-August 1 cases to the current outbreak." But for parents whose babies fell ill long before the August surge, that answer rings hollow.
At least five families say their infants were treated for botulism after drinking ByHeart formula in late 2024 and early 2025, according to reports shared with The Associated Press by Bill Marler, a Seattle food safety lawyer representing the families. Amy Mazziotti of Burbank, California, watched her five-month-old son, Hank, become gravely ill in March, weeks after he began drinking ByHeart. Katie Connolly of Lafayette, California, said her eight-month-old daughter, M.C., was hospitalized in April and treated for botulism after being fed the same formula. For months, both mothers were left to wonder about the cause of their children's mysterious symptoms—until the recall hit the news. "As soon as she heard it was ByHeart, Mazziotti said she thought: 'This cannot be a coincidence.'"
ByHeart, a relatively small player in the infant formula market, accounting for less than 1 percent of U.S. sales, confirmed this month that laboratory tests of previously unopened formula found contamination with Clostridium botulinum, the bacterium that causes botulism. The company notified the U.S. Food and Drug Administration (FDA) and, on November 11, 2025, issued a nationwide recall of all its products. The Canadian Food Inspection Agency (CFIA) followed suit on November 14, warning consumers not to use ByHeart Whole Nutrition Infant Formula due to the risk of contamination. The CFIA noted that, while no illnesses had been reported in Canada, the affected products "may be unsafe because of the potential presence of the dangerous bacteria."
Federal health officials in the U.S. now report that at least 31 babies in 15 states have been hospitalized and treated for infant botulism since August. The most recent case was reported on November 13. The affected infants, ranging in age from about two weeks to six months, exhibited symptoms that included constipation, poor feeding, weak cry, drooping eyelids, and limpness—classic signs of infant botulism. Thankfully, no deaths have been reported, but some babies continue to experience lingering effects even after treatment. As Connolly told The Associated Press, "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?"
Infant botulism is exceedingly rare—less than 200 cases are reported annually in the U.S.—and is typically caused when babies ingest spores that germinate in the gut and produce a potent toxin. The bacterium is common in the environment, found in soil and water, and cases are often linked to environmental exposure or contaminated honey. According to California health officials, before this outbreak, no powdered infant formula in the U.S. had ever tested positive for the botulism-causing bacteria. That changed when, in early November, a sample from a can of ByHeart formula fed to a sick infant tested positive for Clostridium botulinum—prompting the CDC, FDA, and public health agencies to spring into action.
But the response has been far from seamless. As reported by Healthbeat, efforts to remove recalled ByHeart formula from store shelves nationwide have been hampered by bureaucratic delays at the FDA. Steven Mandernach, executive director of the Association of Food and Drug Officials, criticized the agency for not fully sharing ByHeart’s product distribution lists with state and local officials until nearly a week after the recall was announced. "We wasted almost a week," Mandernach said, adding, "You expect all hands on deck. This is infants."
During that critical delay, state and local inspections were slowed, and recalled ByHeart formula continued to be found for sale at about 10% of stores checked, including major retailers like Walmart, Target, and Kroger. The FDA acknowledged the issue, noting that all ByHeart products—including cans and single-serve sticks—should be off the shelves, but reports of lingering stock persisted. Mandernach blamed the holdup on the FDA’s legal team, which considers distribution lists confidential business information, only sharable after privacy agreements or internal exemptions are secured. "No one expects the law to prohibit the agency from trying to share information in this type of event," he said. "For it to take four days for them to figure out how to use that exemption, that’s just not normal."
Food safety advocates say the ByHeart recall is part of a troubling pattern. Sarah Sorscher, director of regulatory affairs for the Center for Science in the Public Interest, told Healthbeat, "This is part of a pattern we’ve seen in recalls, where products are often left on store shelves well after the recall announcement." Barbara Kowalcyk, director of the Institute for Food Safety and Nutrition Security at George Washington University, echoed the concern: "We know recall effectiveness is not as good as it should be. But this particular product involved such a vulnerable population—infants who often rely on formula as their only source of nutrition. I think there needs to be an assessment of why that happened."
ByHeart officials insist they have acted with urgency, notifying all retail partners and program participants, and confirming communication with stores. "We are working to investigate the facts, conduct ongoing testing to identify the source and ensure this does not happen to families again," the company said on its website. The FDA and CDC continue to urge parents and caregivers to stop using any ByHeart formula, mark it "DO NOT USE," and keep it for at least a month in case symptoms develop and testing is needed. Food contaminated with botulism toxin may not look or smell spoiled, but can still cause illness—sometimes with symptoms taking up to 30 days to appear.
For families like the Mazziottis and Connollys, the search for answers and accountability continues. As Connolly put it, "We deserve to know the data that can help us understand how our babies got sick." The ByHeart recall has exposed not only the vulnerabilities in the nation’s food safety system, but also the deep trust parents place in the products they feed their children. As investigations proceed and reforms are debated, the hope is that lessons learned will lead to stronger protections for the youngest and most vulnerable among us.
