Preliminary tests have revealed the presence of bacteria capable of producing the deadly botulism toxin in ByHeart Whole Nutrition Infant Formula, prompting alarm among health officials and parents across the United States. According to statements from the California Department of Public Health, at least 13 infants in 10 states have been hospitalized since mid-August 2025 after consuming the powdered formula. While no deaths have been reported so far, the rapid response from public health authorities underscores the seriousness of the outbreak and the rare nature of its apparent source.
“Consumers in possession of this product should stop using it immediately,” the California Department of Public Health urged in a statement released late Saturday, as reported by the Associated Press. The warning came after state health officials tested a can of ByHeart formula that had been fed to an infant who fell ill. The results “suggest the presence” of the type of bacteria that produces the botulism toxin, though further confirmatory testing could take several days.
The outbreak has affected babies as young as two weeks and as old as five months, all of whom were hospitalized after consuming ByHeart powdered formula, according to the U.S. Centers for Disease Control and Prevention (CDC). The reported cases are spread across Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington. The CDC and the U.S. Food and Drug Administration (FDA) are now investigating a total of 83 reported cases of infant botulism since August, including those linked to ByHeart formula.
ByHeart, a New York-based company founded in 2016, moved quickly to recall two lots—totaling approximately two tons—of its Whole Nutrition Infant Formula, which carried a best-by date of December 2026. The company emphasized in a statement on Sunday, “We take this very seriously,” and noted that “more testing is needed” to confirm whether the specific bacteria responsible for botulism is present in the recalled lots. ByHeart also stressed that the bacteria in question belong to a large family of organisms, many of which are commonly found in the environment and do not cause illness.
Infant botulism, the rare but potentially devastating illness at the center of this outbreak, typically affects fewer than 200 babies in the United States each year. The disease is caused by bacteria that produce toxins in the large intestine, often introduced through hardy spores present in the environment—dust, soil, water, or even contaminated honey. Infants under one year old are particularly susceptible, and symptoms can take weeks to appear. These may include poor feeding, loss of head control, drooping eyelids, a flat facial expression, limp or “floppy” limbs, and difficulty swallowing or breathing. In severe cases, the illness can lead to paralysis.
Dr. Steven Abrams, a nutrition expert at the University of Texas, highlighted the extraordinary nature of this event, telling the Associated Press, “This would be extremely rare.” Indeed, no previous outbreaks of infant botulism have been definitively tied to powdered formula in the United States, making this incident a troubling first for both parents and regulators.
For the infants affected in this outbreak, the only available treatment is BabyBIG, an intravenous medication developed by California’s Infant Botulism Treatment and Prevention Program. This specialized product, made from the pooled blood plasma of adults immunized against botulism, is the sole source of treatment worldwide. BabyBIG is credited with shortening hospital stays and reducing the severity of illness in babies with botulism. Because the infection can compromise an infant’s ability to breathe, many require ventilator support during recovery. According to the CDC, all children affected by the ByHeart outbreak have received this life-saving medication.
Despite the gravity of the situation, federal health officials have reassured the public that there is no current risk of infant formula shortages as a result of the ByHeart recall. The company accounts for only about 1% of national formula sales, and its products are sold both through its website and in retail stores across the country. This stands in stark contrast to the nationwide formula crisis of 2022, when contamination issues at Abbott Nutrition’s Michigan plant led to the recall of top brands and months of shortages. At that time, Abbott’s market share was significantly larger, and the impact on American families was profound.
ByHeart itself has faced scrutiny in the past. In 2022, the company recalled five batches of infant formula after a sample at its packaging plant tested positive for Cronobacter sakazakii, the bacteria at the heart of the Abbott crisis. The following year, the FDA issued a warning letter to ByHeart, detailing “areas that still require corrective actions.” These repeated incidents have contributed to mounting pressure on federal regulators to strengthen oversight of the infant formula industry.
In response to the latest outbreak, Health Secretary Robert F. Kennedy Jr. has directed the FDA to conduct its first comprehensive review of infant formula ingredients since 1998. Dubbed “Operation Stork Speed,” this initiative aims to reassess the nutrients and other components in formula products, which are relied upon by millions of American families. FDA officials are currently reviewing input from industry representatives, health experts, and the public to determine the next steps. This renewed scrutiny follows a series of contamination scares and is part of a broader effort to overhaul the U.S. food supply.
While the investigation continues, health authorities remain vigilant. The FDA and CDC are working closely with state agencies to trace the source of contamination, monitor for additional cases, and ensure that recalled products are removed from shelves and homes. Parents and caregivers are urged to check their formula supplies and consult with healthcare providers if they have concerns about their child’s health.
For now, the focus remains on the well-being of the affected infants and the lessons that can be drawn from this rare outbreak. As the FDA’s review gets underway and the industry faces renewed calls for transparency and safety, families across the country are reminded of both the fragility of the systems they depend on and the importance of swift, coordinated action in the face of emerging health threats.
As the days ahead bring further test results and regulatory decisions, the hope is that increased vigilance and oversight will help prevent future outbreaks and ensure the safety of the nation’s youngest and most vulnerable.
