On November 8, 2025, the Centers for Disease Control and Prevention (CDC) announced a concerning outbreak of infant botulism linked to ByHeart Whole Nutrition Infant Formula, thrusting new parents and health officials across the United States into a scramble for answers and action. Since August, at least 23 cases have emerged in 13 states, with infants as young as a few months old falling ill after consuming the formula, according to the CDC and the Food and Drug Administration (FDA). While no deaths have been reported, several infants remain hospitalized as of mid-November, and the national recall of ByHeart’s product is in full effect.
The FDA initially recalled two lots of ByHeart Whole Nutrition Infant Formula, but by November 11, the agency had expanded the recall to include all lots sold in 24-ounce cans and 0.6-ounce single-serving packets. The urgency of the recall was underscored by the Oregon Health Authority (OHA), which confirmed that two babies in Oregon became sick after drinking the formula. OHA spokesperson Dr. Howard Chiou emphasized, “Our message is clear: Do not use ByHeart infant formula.”
Parents nationwide have been advised to check their pantries for any remaining ByHeart formula, label it as “DO NOT USE,” and keep it stored safely for at least a month. This precaution ensures that, should an infant develop symptoms, the product can be tested to help trace the outbreak’s source. The CDC and state health departments have cautioned against discarding the formula immediately, as unopened containers and lot numbers may be needed for investigation. After a month without symptoms, the leftover formula should be discarded.
Symptoms of infant botulism can be insidious and slow to develop, sometimes taking several weeks to appear. The CDC and state health authorities have listed a range of warning signs for parents and healthcare providers to watch for: constipation, poor feeding, diminished suck and gag reflexes, ptosis (drooping eyelids), altered or blunted facial expression, decreased pupillary reaction, weak or altered cry, poor head control, hypotonia (reduced muscle tone), and symmetric, descending flaccid paralysis. The OHA further highlighted poor feeding, loss of head control, difficulty swallowing, and decreased facial expression as key symptoms that warrant immediate medical attention.
Infant botulism is a rare but potentially fatal condition caused by spores of the Clostridium botulinum bacterium, which can colonize an infant’s intestines and produce a powerful neurotoxin. This toxin gradually paralyzes the baby, leading to feeding difficulties, muscle weakness, and—if untreated—potentially life-threatening respiratory failure. According to the CDC, most affected infants are under six months old, but cases can occur until an infant’s first birthday. While the spores are widespread in the environment, identification of a specific contaminated commercial product, as in this outbreak, is rare. Honey is another known source, and health officials reiterate that infants should never be fed honey or foods containing honey.
Healthcare providers are on high alert. The FDA and CDC have instructed clinicians to immediately contact the California Department of Public Health’s Infant Botulism Treatment and Prevention Program (IBTPP) if botulism is suspected. The IBTPP provides 24/7 clinical consultation and access to BabyBIG®, the only botulism immune globulin intravenous (BIG-IV) treatment approved for infants. Treatment should begin as soon as possible, without waiting for laboratory confirmation, as BabyBIG® can prevent further progression of paralysis, though it does not reverse existing symptoms. Early intervention is critical, as prompt administration can prevent the need for intubation and reduce the length of hospital stays.
States like Louisiana, which have not yet reported any cases, are taking no chances. The Louisiana Department of Health is working with retailers to remove ByHeart products from shelves and has urged parents and caregivers to seek immediate medical care if an infant has consumed the formula or displays any symptoms. Caregivers with unused formula are advised to return it to stores or dispose of it, and to thoroughly wash any items or surfaces that may have come into contact with the product using hot soapy water or a dishwasher.
Behind the immediate health scare lies a deeper story of regulatory scrutiny and corporate accountability. According to The New York Times, federal investigators found multiple safety violations at a ByHeart manufacturing plant in Reading, Pennsylvania, earlier in 2025, including a leaking roof and hundreds of dead insects in areas where formula was produced. The FDA classified its inspection at the highest tier of concern. Although these findings did not involve the specific plants linked to the recalled formula, food safety experts have raised alarms about the company’s safety record.
Further, ByHeart’s rapid ascent in the infant formula market came amid a national shortage in 2022, when parents were desperate for alternatives after a major Abbott Nutrition facility shutdown. ByHeart, founded by Ron Belldegrun and Mia Funt, positioned itself as a high-quality, health-focused option, even touting its use of whole milk to better mimic breast milk. The company grew quickly, raising over $70 million from investors and expanding its products to major retailers such as Amazon, Target, Kroger, and Albertsons. ByHeart products now account for roughly 1% of infant formula sales in the U.S., a seemingly small share but enough to trigger a national recall and widespread concern.
ByHeart has responded to the crisis by voluntarily recalling all affected formula, cooperating with the FDA, and granting inspectors unrestricted access to its facilities. In a statement, company president Mia Funt said, “We express our deepest sympathy to the families currently impacted by the cases of infant botulism. We are working with the F.D.A. and independent experts to implement the recall quickly while the factual investigation continues.” The company has also begun extensive batch testing and maintains that none of the bacteria have been found in unopened cans, though The New York Times reports that Clostridium botulinum was found in an opened can of ByHeart formula.
The outbreak has already led to legal action. At least two families have filed lawsuits against ByHeart, alleging negligence and dangerous manufacturing practices. One case, brought by Stephen and Yurany Dexter of Arizona, describes how their daughter became so weak after using the formula that she required air ambulance transport and was hospitalized with a feeding tube. The family is uncertain about potential long-term effects. In Kentucky, Hanna and Michael Everett sued after their 4-month-old daughter was diagnosed with botulism and required emergency treatment.
Despite the recall, federal officials have assured the public that the outbreak does not threaten the overall supply of infant formula, given ByHeart’s relatively small market share. Still, the incident has reignited debates about food safety oversight. Sandra Eskin, chief executive of the advocacy group Stop Foodborne Illness, said, “They do not at all in any of their drafts or reports or outlines talk about foodborne illness… for many, many people, they have lifelong health consequences.”
As the investigation continues, health authorities urge parents and caregivers to remain vigilant for symptoms in infants who have consumed ByHeart formula. The CDC, FDA, and state health departments continue to update the public as new information emerges. For now, the message is clear: stop using the recalled formula, watch for symptoms, and seek medical care promptly if any develop. The hope is that swift action and increased awareness will prevent further harm—and perhaps prompt lasting improvements in food safety for the nation’s youngest and most vulnerable.
