Federal health officials are sounding the alarm as the number of infants hospitalized with botulism linked to ByHeart Whole Nutrition powdered infant formula has climbed to 31 across 15 states, according to updated advisories from the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). The outbreak, which began to unfold in early August 2025, has now prompted a sweeping recall of all ByHeart formula products and a nationwide push to remove potentially contaminated cans and sticks from store shelves and homes.
In a series of advisories and public statements, the CDC and FDA detailed the rapid escalation of the outbreak. As of November 20, 2025, the agencies confirmed that all 31 affected infants had been hospitalized, though, notably, no deaths have been reported. The illnesses, which began as early as August 9 and continued through November 13, have now been identified in Arizona, California, Idaho, Illinois, Kentucky, Maine, Michigan, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington. Of the 23 infants for whom age and sex information is available, ages range from just 16 days to 200 days old, with 11 of the patients being female, the CDC reported.
ByHeart, a relatively new player in the infant formula market—making up about 1% of U.S. sales—first announced a voluntary recall on November 8, 2025, after being notified by the FDA of the ongoing outbreak investigation. The company initially recalled two batches of its Whole Nutrition Infant Formula, but within days expanded the recall to include all batches of its formula cans and single-serve "Anywhere Pack" sticks nationwide. By November 19, ByHeart confirmed that third-party laboratory testing had identified the bacteria Clostridium botulinum in some unopened samples of its formula.
In a statement posted to its website, ByHeart said, "After the FDA informed us of the infant botulism outbreak on November 7, we immediately partnered with IEH Laboratories & Consulting Group, a global leader in Food Safety testing, to test cans of ByHeart formula, and conducted a nationwide recall. 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." The company added, "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."
Clostridium botulinum is a bacterium that can produce botulinum toxin, one of the most potent toxins known to science. When ingested, especially by vulnerable infants, it can cause botulism—a rare but life-threatening illness. According to the CDC, the toxin attacks the nervous system, leading to symptoms like poor feeding, constipation, drooping eyelids, low muscle tone, weak cry, difficulty swallowing, loss of head control, and in severe cases, respiratory arrest. The CDC warns, "Seek immediate medical care if your infant has consumed ByHeart Whole Nutrition Infant Formula and has any of these symptoms: poor feeding; loss of head control; difficulty swallowing; decreased facial expression."
Botulism in infants most commonly affects those under 12 months of age, with the highest risk among babies younger than two months, according to the Department of Agriculture's Food Safety and Inspection Service. The illness can develop after they ingest spores—often from foods like honey—that germinate and produce neurotoxin in the gut. For this reason, health authorities have long advised against giving honey to infants under one year old. The ByHeart outbreak, however, has brought formula—a staple for many families—under scrutiny, highlighting how even products designed for the most vulnerable can become vectors for serious illness if contaminated.
Despite the recall, the FDA reports that ByHeart formula products have continued to turn up on store shelves at major retailers including Walmart, Target, Kroger, Sprouts Organic Market, Safeway, Jewel-Osco, Shaw’s, and Star Market, as of November 20. The FDA is working with state partners and retailers to ensure an effective recall and immediate removal of these products. The agency emphasized that all ByHeart infant formula products have been recalled and should not be available for sale in stores or online. The recall also extends internationally, as customer data from Amazon revealed shipments of the recalled formula to countries including Argentina, Brazil, Canada, China, Israel, Japan, South Africa, and many others. Consumers worldwide are urged not to use any ByHeart brand infant formula.
For parents and caregivers, the recommendations from health authorities are clear and urgent: Stop using any ByHeart infant formula products immediately. If your child has consumed ByHeart formula and is experiencing symptoms such as poor feeding, loss of head control, or difficulty swallowing, seek immediate medical attention. If no symptoms are present, continue monitoring your child and consult a healthcare provider if any concerning signs develop. The CDC also advises parents to take a photo or record the information on the bottom of the formula package, keep the container labeled as "DO NOT USE," and, if symptoms develop, be prepared to provide the container for testing by health officials. If no symptoms appear after 30 days, the container should be discarded.
Retailers are being reminded to ensure that no recalled product remains on shelves, including items that may have been returned by customers. The FDA has also issued guidance for physicians: If an infant patient is suspected of having botulism, clinicians should immediately call 510-231-7600 for case consultation, which is available 24/7.
While the outbreak has caused understandable anxiety among families, the FDA and CDC have sought to reassure the public that the recall does not create a shortage of infant formula nationwide, given ByHeart’s relatively small market share. Investigations remain ongoing, with additional testing and analysis underway to determine the exact point of contamination within the supply chain. The agencies caution that detection of Clostridium botulinum in infant formula is complex and that a negative test result does not necessarily rule out contamination.
ByHeart’s president and co-founder, Mia Funt, told ABC News, "The safety and well‑being of every infant who uses our formula is, and always will be, our highest priority." The company has reiterated its commitment to working with federal and state authorities to identify the source of contamination and prevent future outbreaks.
The multistate investigation, led by the FDA and CDC in collaboration with the California Department of Public Health’s Infant Botulism Treatment and Prevention Program and other partners, is ongoing. As new information emerges, the agencies have pledged to keep the public informed and to update their advisories as needed.
For now, the message from health officials is unequivocal: vigilance and swift action are the best defenses against this rare but dangerous illness. Families are urged to heed recall notices, monitor their infants closely, and seek medical help at the first sign of trouble. As the investigation continues, the hope is that lessons learned will lead to even greater safeguards for the youngest and most vulnerable members of society.
