When Stephen and Yurany Dexter welcomed their daughter Rose in July 2025, they never imagined that a simple decision about infant formula would upend their lives. Yet, by August, Rose—just a month old—began exhibiting troubling symptoms: constipation, gas, and a persistent tummy discomfort. Initially, her pediatrician brushed it off as normal baby woes. But as Stephen later told CNN, "Looking back at the photos, she was losing weight. She looked sick. And the entire time during the decline, Mom had been saying something was wrong."
That "something" was infant botulism, a rare but potentially deadly illness caused by the spores of the bacterium Clostridium botulinum. The toxin it produces is among the most powerful known to science, and it was gradually paralyzing Rose. She is now one of at least 31 infants across 15 U.S. states who have developed botulism after consuming powdered formula from ByHeart, a brand that markets itself as a natural, health-conscious choice for families. As The Associated Press reported, laboratory tests of 36 samples from three different lots of ByHeart formula revealed that five samples contained Clostridium botulinum type A. This led to a sweeping nationwide recall on November 11, 2025.
The scale and nature of this outbreak have stunned experts. Bill Marler, a food safety attorney representing several affected families, told CNN, "This outbreak has me very worried. It is certainly the largest foodborne illness outbreak that I’ve heard of in 32 years due to infant formula." Dr. Steve Abrams, a neonatologist at the University of Texas at Austin, echoed this sentiment: "This is an insane level of patients, babies affected. I think you’d have to go back very far to find this many babies affected by a disease state from contaminated formula."
Despite the recall, the U.S. Food and Drug Administration (FDA) has received reports that ByHeart formula remains on store shelves in multiple states, including major retailers such as Wal-Mart, Target, Kroger, and Sprouts. The product has also been sold through online marketplaces, reaching customers overseas. The FDA issued a stark warning: "Consumers worldwide should not use any ByHeart brand infant formula as all ByHeart products are included in this recall."
The Canadian Food Inspection Agency (CFIA) also sounded the alarm, cautioning Canadians not to consume ByHeart Whole Nutrition Infant Formula, even though no cases have been reported in Canada. According to the National Post, the formula is available for sale online, and the agency emphasized that it should not be used under any circumstances.
The recall itself unfolded in stages. ByHeart was first informed by the FDA about the outbreak on November 7, 2025, and promptly sent unopened cans of formula for third-party testing. When the presence of Clostridium botulinum was confirmed, the company initially recalled two batches on November 8, then expanded the recall to all infant formula products by November 11. However, the persistence of the product on store shelves has frustrated parents and health officials alike. As Dr. Abrams noted, "We have these disturbing reports of 10 days after the recall, people are going into stores and still find cans of ByHeart. This recall is testing some real untested waters that we haven’t seen before."
Litigation has quickly followed. At least four families have filed lawsuits against ByHeart, alleging negligence in selling defective formula that sickened their babies. Bill Marler, who represents several of these families, told NBC News, "If there’s a product that should be safe, it should be infant formula. ByHeart has a lot to answer for."
Food safety experts say several factors make this outbreak particularly alarming. For one, botulism is rarely associated with dairy products. As Jeff Farber, director of a global food safety consulting firm and adjunct professor at the University of Guelph, told the National Post, "Prior to the outbreak investigation, no powdered infant formula had actually tested positive for Clostridium botulinum in the United States." He added, "Powdered formula companies are going to have to put this as a hazard in their hazard analysis program."
ByHeart, for its part, has pledged to get to the bottom of the contamination. In a statement on its website, the company said it is "doing everything we can to ensure this investigation reveals solutions and aids in understanding cases of infant botulism broadly. That’s what parents, the medical community, and you deserve." The company is conducting a rigorous audit of every step in its product development chain—from suppliers and raw ingredients to packaging and transportation—and has expanded its refund policy for customers who purchased formula on or after August 1, 2025.
Infant botulism is an insidious disease. The spores can be unevenly distributed in powdered formula, and not all babies who ingest them will become ill. But all infants under one year are at risk. Symptoms can take up to 30 days to appear and may include constipation, difficulty feeding, drooping eyelids, flat facial expression, and weakness in the arms, legs, and head. As Dr. Erica Pan, California’s state public health officer, explained to CNN, "It’s a slow progression. You first might notice droopy eyelids or some parents notice, like, their infant’s expressions are not as expressive."
Immediate medical attention is critical. The only treatment is an antitoxin called BabyBIG, manufactured by the California Department of Public Health. It is the sole therapy available worldwide for infant botulism and is so effective that it dramatically reduces hospital stays. Since August 1, 2025, at least 107 babies nationwide have been treated with BabyBIG, according to health officials.
The outbreak has also cast a spotlight on the broader issue of infant formula safety. ByHeart previously recalled batches of its formula in 2022 due to potential contamination with Cronobacter sakazakii, and in 2023, the FDA cited the company for significant violations at its Pennsylvania manufacturing facility. Keith Warriner, a professor at the University of Guelph, drew a parallel with the 2022 Abbott baby formula recall, which led to a national shortage. "Maybe this is a consequence of having so few providers of infant formula," Warriner mused. "Are these highly centralized facilities the best thing to have when we’re looking at things like infant formula, because it makes the chain so vulnerable?"
For families like the Dexters, the ordeal has been harrowing. Yurany Dexter reflected, "I feel like it was a nightmare, all the things that happened for us." Stephen added, "You just keep getting more and more angry, just kind of reflecting and going, how did this happen?" Rose is now recovering, but her parents and many others are left with lingering questions—and a hope that the investigation will prevent future tragedies.
As investigators race to identify the precise source of contamination, the message from health officials is clear: If you have ByHeart formula, do not use it. Lock it away, label it "Do Not Use," and monitor babies closely for symptoms. For now, the focus remains on protecting the most vulnerable—infants—and ensuring that the lessons from this outbreak lead to safer food for all.
