On November 11, 2025, ByHeart, a New York-based organic infant formula manufacturer, issued a sweeping nationwide recall of all its powdered formula products. The move came after laboratory testing confirmed the presence of Clostridium botulinum type A—bacteria capable of causing life-threatening botulism—in multiple product samples. This recall, which the company described as a necessary precaution, has triggered a wave of concern, legal action, and official scrutiny as dozens of infants across the United States have fallen ill.
According to the U.S. Food and Drug Administration (FDA), as of late November, 37 confirmed or suspected cases of infant botulism have been reported in babies who consumed ByHeart formula since August 2025. The most recent case was documented on November 19. Of these cases, 31 were officially confirmed, with all affected infants hospitalized. The outbreak spans at least 18 states, including Arizona, California, Illinois, Kentucky, and Texas, highlighting the widespread distribution and reach of ByHeart’s products.
ByHeart, which accounts for about 1% of the U.S. infant formula market and had been selling approximately 200,000 cans per month, found itself at the center of an unprecedented crisis. The company’s recall was prompted by lab results showing Clostridium botulinum spores in five of 36 samples from three separate lots. Because powdered formula can harbor bacteria unevenly, ByHeart stated it “cannot rule out the risk that all ByHeart formula across all product lots may have been contaminated.” This admission sent shockwaves through the parenting community, especially as powdered infant formula had not previously been linked to known outbreaks of infant botulism, according to Associated Press reporting.
Federal and state health officials have been quick to respond. The FDA launched investigations at ByHeart’s manufacturing plants in Allerton, Iowa, and Portland, Oregon, while California officials confirmed the presence of botulism-causing bacteria in an open can of ByHeart formula fed to an ill infant. Despite the recall, some ByHeart formula remained on store shelves as of late November, prompting renewed warnings from health agencies and calls for increased vigilance among retailers and parents alike.
The symptoms of infant botulism can be insidious and slow to appear—sometimes taking up to 30 days after exposure. Medical experts and the FDA have urged parents and caregivers to stop using ByHeart formula immediately and to monitor infants for warning signs such as constipation, difficulty feeding, drooping eyelids, facial weakness, reduced muscle tone, and lethargy. In severe cases, babies may lose head control, exhibit a flat facial expression, or experience breathing difficulties. As the Centers for Disease Control and Prevention (CDC) notes, infants under 12 months are particularly vulnerable because their gut microbiomes are not mature enough to fend off the spores that produce the dangerous toxin.
Since August 1, at least 107 infants nationwide have been treated with BabyBIG, an intravenous medication made from the pooled plasma of adults immunized against botulism. Developed by California’s infant botulism program, BabyBIG is the only treatment available worldwide and is credited with shortening hospital stays and reducing the severity of illness. Many of the affected infants have required intensive medical intervention, including ventilators, IVs, and feeding tubes—a harrowing ordeal for families who believed they were making a healthy choice by selecting an organic, premium formula.
The legal fallout has been swift and significant. As of November 29, at least seven additional families have filed lawsuits against ByHeart, alleging that the company’s formula was defective and that ByHeart was negligent in its safety practices. These lawsuits, filed in federal courts, describe traumatic experiences: infants hospitalized for weeks, parents wracked with fear and uncertainty, and staggering medical bills. The families are seeking compensation for medical costs, emotional distress, and other damages. According to GLK Law, "Parents should understand that they do have legal rights. They are able to hold the manufacturer of different products legally accountable for their child’s illness through a product liability claim."
ByHeart’s troubles did not begin with this outbreak. In 2022, the company recalled five batches of infant formula after a sample at its packaging plant tested positive for cronobacter sakazakii, a different but also dangerous germ. In 2023, the FDA sent a warning letter highlighting “areas that still require corrective actions,” and a ByHeart plant in Reading, Pennsylvania, was shut down after inspectors found mold, water leaks, and insects. These prior incidents have only intensified scrutiny of ByHeart’s manufacturing processes and oversight.
Industry experts and public health advocates emphasize that manufacturers have a legal and ethical obligation to enforce strict ingredient control, maintain rigorous environmental monitoring, and prevent moisture intrusion throughout the supply chain. As the CDC explains, botulism is caused by a toxin that attacks nerve cells, potentially leading to paralysis and even death if it impairs breathing muscles. “Botulinum toxin blocks nervous system signals. Those signals tell your muscles when to activate and when to relax. Blocking those signals causes paralysis. And botulism can be deadly when the paralysis blocks signals to the muscles you use to breathe,” the Cleveland Clinic warns.
For parents grappling with the fear and uncertainty of a potential botulism diagnosis, experts advise immediate medical evaluation if symptoms arise, preserving the suspected source of contamination for investigation, and consulting legal counsel to understand their rights. The trauma of watching a child suffer from such a rare and dangerous illness is profound, and the path to recovery—both medical and emotional—is often long and uncertain.
Meanwhile, federal officials are using this crisis as an impetus to review the broader U.S. infant formula supply. Under the direction of Health Secretary Robert F. Kennedy Jr., the FDA has launched “Operation Stork Speed,” a comprehensive review of infant formula ingredients and manufacturing standards—the first such deep dive since 1998. The agency is now considering comments from industry, health experts, and the public to determine next steps. This renewed focus on safety and transparency comes as a relief to many, especially in light of the formula shortages that rocked the nation in 2022 following unrelated contamination issues at another major manufacturer, Abbott Nutrition.
Despite ByHeart’s relatively small market share, the recall has left many parents scrambling for safe alternatives amid lingering supply chain challenges. The company has expanded its refund policy to cover all purchases made through its website on or after August 1, 2025, and encourages consumers to report illnesses to the FDA’s MedWatch program or local consumer complaint coordinators.
This outbreak stands as a sobering reminder of the vulnerability of the youngest Americans and the critical importance of rigorous safety standards in the food supply. As investigations continue and families seek justice, the hope is that lessons learned will prompt lasting improvements—ensuring that no parent must face such uncertainty again.
