When parents reach for a can of infant formula, they expect safety and nourishment, not a medical emergency. Yet, for dozens of families across the United States, ByHeart—an infant formula brand once chosen for its organic ingredients and minimal additives—has become the focus of a harrowing public health crisis and a deepening sense of betrayal.
The California Department of Public Health (CDPH) is now investigating six additional cases of infant botulism in babies who consumed ByHeart formula between November 2024 and June 2025, months before the current outbreak began, according to Bloomberg. These cases, which predate the wave of illnesses that started in August 2025, have not yet been definitively linked to the formula, but they have added urgency to the ongoing scrutiny of ByHeart’s safety standards and manufacturing practices.
ByHeart, a company that marketed itself as a healthier alternative—prizing organic whole milk and clean labels—recalled two batches of its formula on November 8, 2025, and expanded the recall to all its products just three days later. The move came after federal health officials linked 31 confirmed or suspected infant botulism cases to ByHeart formula consumption across 15 states since August. Every affected baby required hospitalization and specialized treatment, though, remarkably, no deaths have been reported so far.
Botulism, a rare but potentially deadly illness, is caused by a toxin produced by the bacterium Clostridium botulinum. The bacteria’s spores are common in the environment, found in soil and water, as the World Health Organization notes. But when they make their way into food, especially for infants, the results can be catastrophic. The toxin attacks the nerves, leading to symptoms such as constipation, drooling, muscle paralysis, and, in severe cases, respiratory failure or death. According to NBC News, the only treatment for infant botulism, BabyBIG, is provided by CDPH and had to be rushed to hospitals around the country as the crisis unfolded.
Brian Micek, a spokesperson for CDPH, told Bloomberg, “Prior to this outbreak investigation, no powdered infant formula had tested positive for Clostridium botulinum in the United States. Additionally, the number of cases in general were within expected case numbers based on previous year’s trends, and disease presentation wasn’t consistent with an outbreak.” Yet, by August, CDPH officials noticed an unusual uptick in cases on the East Coast—many testing positive for a toxin type rarely seen in that region. ByHeart’s formula was increasingly prevalent among these cases, prompting CDPH to alert the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA).
Testing the formula for contamination has proven challenging. In one case, CDPH tested an open can of ByHeart formula that had been fed to a baby with confirmed botulism; the can tested negative. But as the FDA has emphasized, detection of Clostridium botulinum is complex—a negative result doesn’t guarantee the absence of bacteria. As of November 19, 2025, CDPH had deployed its BabyBIG treatment to 107 infants nationwide, a striking figure given that the CDC reported 181 infant botulism cases in all of 2021.
For families, the ordeal has been nothing short of traumatic. At least four have filed lawsuits against ByHeart, describing terrifying days and nights in the hospital as their infants endured IV drips, feeding tubes, and the constant fear of losing their child. Many parents, like Hanna Everett of Richmond, Kentucky, said they chose ByHeart for its promise of purity. Yet, Everett’s daughter, Piper, was hospitalized on November 9, 2025, after showing symptoms like constipation and drooping eyelids. “They’re holding your child down that’s not even 4 months old technically at the time, and she’s just screaming bloody murder. And there’s nothing you can do,” Everett told NBC News. Piper received the antitoxin via IV, which had to be flown in because it’s not routinely stocked at hospitals. Thankfully, she was released about a week later, but Everett still grapples with guilt. “It feels like I let her down when I know that’s not the case. It’s hard to tell yourself that as a mother, because you’re going to blame yourself,” she shared.
Everett and her husband have since sued ByHeart, seeking damages for medical bills and emotional distress. She expressed frustration at the company’s response, saying, “It makes me more angry and just sick to my stomach that it took them as long as it did to own up to this. It’s almost like too little, too late.” According to Everett, ByHeart even offered to send her more formula cans after she contacted them about the recall—an offer she found deeply unsettling.
Other families echoed similar fears and anguish. A Washington state couple described in their lawsuit how their daughter suffered chronic constipation, feeding difficulties, and extreme fatigue while on ByHeart formula, culminating in an emergency room visit at just two months old. In California, Anthony Barbera and Thalia Flores said their son was so weak from botulism that by the time he received the antitoxin, he could no longer eat or even cry, according to their legal filing. Arizona parents Stephen and Yurany Dexter recounted their terror as their daughter stopped eating altogether and had to be flown by air ambulance to a children’s hospital.
Bill Marler, the attorney representing several affected families, minced no words: “If there’s a product that should be safe, it should be infant formula. ByHeart has a lot to answer for.”
ByHeart has publicly confirmed the presence of Clostridium botulinum spores in samples of its formula. The company said in a statement, “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.” However, ByHeart has not yet identified the root cause of the contamination. Initially, the company recalled only two lots, arguing that a positive test came from an opened can, which could have been contaminated after purchase. But mounting evidence and pressure led to a sweeping recall of all products.
This isn’t ByHeart’s first brush with regulatory trouble. In December 2022, the company recalled batches due to possible contamination with a different bacteria, Cronobacter sakazakii, which was also at the center of the 2022 Abbott Nutrition recall that triggered a national formula shortage. In 2023, the FDA sent a warning letter to ByHeart citing “significant violations” at its Pennsylvania facility, including water leaks and unresolved questions about earlier contamination. ByHeart insists that the Pennsylvania plant was not involved in the current recall and that it has addressed all prior issues.
Food safety experts note that formula makers are not required to routinely test for Clostridium botulinum but must adhere to strict sanitary controls and FDA inspections. Abigail Snyder, a microbial food safety professor at Cornell University, told NBC News that an FDA warning letter like ByHeart’s is “pretty unusual,” though regulatory scrutiny has increased since the Abbott recall. “Fewer ingredients and whole milk is a different attribute than microbial safety, unfortunately,” she observed.
For parents like Madison Wescott of Washington, the crisis has shaken their trust in formula companies and left them feeling helpless. “Knowing that I can’t fully feed my child, and I can’t trust formula companies has really taken a toll on our family,” Wescott said in legal filings.
As ByHeart continues its root cause investigation and federal agencies monitor for further cases, families across the country are left demanding answers—and hoping that lessons learned will prevent another crisis from ever unfolding again.
