Federal health officials have dramatically expanded the recall of ByHeart Whole Nutrition Infant Formula following a rare and unprecedented outbreak of infant botulism that has now sickened at least 51 babies across 19 states. The U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) announced this week that all ByHeart formula products produced since the company’s launch in March 2022 could have been contaminated with the dangerous Clostridium botulinum bacteria, prompting urgent warnings to parents and caregivers nationwide.
The outbreak, first identified in the summer of 2025, initially appeared to be limited to cases that developed after August 1, 2025. But as the CDC broadened its definition of affected cases and dug deeper into previous reports, the scope of the crisis grew. According to 607NewsNow and the CDC, an additional 10 cases dating from December 2023 through July 2025 were uncovered, bringing the total to 51 infants who have been hospitalized with botulism symptoms linked to ByHeart formula. Thankfully, no deaths have been reported, but the situation has rattled parents and raised questions about food safety oversight.
"While we typically expect to see 150-180 individual cases of infant botulism annually, an outbreak of infant botulism is unprecedented," Dr. Jennifer Cope, chief of the CDC’s Enteric Diseases Epidemiology Branch, told reporters. The CDC’s rapid response, in partnership with the California Department of Public Health’s Infant Botulism Treatment and Prevention Program, was credited with expanding the investigation and potentially saving lives. The agency was first alerted to a concerning spike in cases on November 7, 2025, and by the following day had already begun urging parents to stop using two lots of ByHeart formula. That warning was quickly expanded to cover all ByHeart products just days later.
ByHeart, a relatively new entrant to the U.S. formula market, had previously issued its first recall in December 2022 over possible Cronobacter contamination—a different and unrelated bacteria. The current crisis, however, is tied to the much rarer and more dangerous Clostridium botulinum, which can produce a potent neurotoxin in infants’ intestines. According to the CDC, "Infant botulism happens when a baby swallows Clostridium botulinum spores that grow in the gut and make toxin." Symptoms often begin with constipation but are usually first noticed as feeding difficulties, a weak or altered cry, and loss of head control. In severe cases, the illness can cause paralysis or even death.
The age range of affected infants spans from just 2 weeks to 9 months, with cases reported as early as December 24, 2023, and as recently as December 1, 2025, according to Fox News and the CDC. States impacted include Arizona, California, Idaho, Illinois, Kentucky, Massachusetts, Maine, Michigan, Minnesota, North Carolina, New Jersey, Ohio, Oregon, Pennsylvania, Rhode Island, Texas, Virginia, Washington, and Wisconsin. The CDC and FDA have emphasized that all ByHeart formula products—regardless of lot number or packaging—should be considered potentially unsafe. "All ByHeart infant formula products have been recalled, and these products should not be available for sale in stores or online. This includes all formula cans and single-serve ‘anywhere pack’ sticks," the FDA stated.
ByHeart responded by recalling all of its formula products nationwide on November 11, 2025. The company explained, "Based on these results, we cannot rule out the risk that all ByHeart formula across all product lots may have been contaminated." ByHeart said it immediately partnered with IEH Laboratories & Consulting Group to test unopened cans and began a rigorous audit of its supply chain, from raw ingredients to packaging and transportation. "We continue to be focused on finding the root cause, through a rigorous audit of every step of our product development chain," the company said on its recall website.
Despite the recall, health officials warn that the number of cases could still rise. Botulism symptoms can take up to 30 days to appear after exposure, so families who used ByHeart formula in recent weeks are urged to remain vigilant. The CDC recommends that any leftover formula be labeled “do not use” and stored safely for at least a month, in case state health departments need to collect samples for testing. Surfaces and items that may have come into contact with the formula should be washed with hot, soapy water or run through a dishwasher.
For those whose infants develop symptoms—constipation, poor feeding, floppy limbs, drooping eyelids, or trouble breathing or swallowing—immediate medical attention is essential. According to the CDC, all infants in the current outbreak were hospitalized and treated with BabyBIG®, an intravenous antitoxin developed by California’s infant botulism program. BabyBIG is made from plasma of immunized adults and is the only treatment of its kind in the world. The antibodies it provides are most effective for about a month but may persist longer in the child’s system.
ByHeart’s formula, though a small player in the overall U.S. market (about 1% of sales, per the FDA), was sold both online and at major retailers. The recall covers every lot number and all sizes, and customers are advised to request refunds directly from the retailer where they purchased the product. ByHeart has established a website to guide affected families through the refund process.
The outbreak has also triggered legal action. According to NBC News, at least four families whose babies developed botulism after consuming ByHeart formula have filed lawsuits against the company, alleging negligence and seeking compensation for medical costs and emotional distress. The company has not publicly commented on the litigation but has pledged transparency and continued investigation into the source of the contamination.
As of December 12, 2025, no new ByHeart formula has been found on store shelves since November 26, and the FDA is continuing its investigation. The agency’s message is unequivocal: “Parents and caregivers of infants who consumed ByHeart Whole Nutrition Infant Formula should remain vigilant for symptoms, and seek immediate medical attention if the symptoms develop.”
This outbreak, the first of its kind for infant botulism in the U.S., has shaken trust in a sector that millions rely on for the most basic of needs. As officials and ByHeart work to identify the root cause, families are left hoping for answers—and for the safe return of a product they once trusted to nourish their children.
