As the United States grapples with the aftermath of a widespread infant botulism outbreak, parents, health officials, and legal advocates are sounding the alarm over the continued sale and impact of ByHeart Whole Nutrition Infant Formula—a product now at the center of a national food safety crisis. Despite a recall issued in November 2025, the formula suspected of sickening nearly 40 infants remains on the shelves of major retailers, putting families across the country on edge and prompting a wave of lawsuits and urgent calls for corporate accountability.
The Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) have been investigating the outbreak since August 2025, with cases now confirmed in 18 states from Texas to Massachusetts. According to the CDC, as of December 4, 2025, at least 39 babies have been hospitalized after consuming ByHeart’s formula. While no deaths have been reported, the severity of the illness and the vulnerability of those affected—infants as young as 16 days old—have left families devastated and searching for answers.
“I wouldn’t guess that a product designed for a helpless, developing human in the United States could cause something this severe,” Stephen Dexter of Arizona told the Associated Press after his four-month-old daughter, Rose, spent weeks in the hospital battling botulism. His sentiment echoes the disbelief and frustration felt by many parents, including Hanna Everett of Kentucky, whose baby Piper was also hospitalized: “She’s so little and you’re just helplessly watching this.”
Infant botulism is a rare but potentially deadly disease that occurs when babies ingest spores of Clostridium botulinum. Once inside the gut, these spores can produce toxins that attack the nervous system, leading to symptoms such as poor feeding, constipation, loss of head control, difficulty swallowing, drooping eyelids, and decreased facial expression. In severe cases, infants can experience progressive, flaccid paralysis that may require weeks of hospitalization and, in some instances, intensive care and life-saving treatments like the BabyBIG botulism anti-toxin.
Tragically, the story of one family—shared by food safety attorney Bill Marler—illustrates the harrowing reality many are facing. Their child endured weeks in the intensive care unit, reliant on a feeding tube, with medical expenses and lost wages now reaching into six figures. To make matters worse, some costs were denied coverage by insurers, deemed “experimental.” Marler, whose Seattle-based law firm Marler Clark has been retained by 28 affected families, is calling on ByHeart to “fulfill their corporate responsibility by looking out for their customers” and cover the medical bills and lost wages of those impacted.
“The cost of treating victims of Botulism infections can run in the tens of thousands of dollars, or in a severe case, even in the hundreds of thousands of dollars. These families need ByHeart to do more than promise to cooperate in the investigation into this outbreak,” Marler said. He pointed out that other companies, such as Chi-Chi’s, Dole, and Jack in the Box, have previously advanced medical costs for victims of foodborne illness traced to their products.
The scope of the outbreak is alarming. According to Food Safety News, as of late November, 37 infants across 17 states—including Washington and Idaho—had been hospitalized with suspected or confirmed botulism after consuming ByHeart formula. The FDA had previously notified ByHeart of an estimated 83 cases nationwide, with 13 infants confirmed to have consumed their product. Laboratory testing by ByHeart and the California Department of Public Health confirmed the presence of Clostridium botulinum in formula samples.
Despite the recall of ByHeart’s Whole Nutrition Infant Formula cans and Anywhere Pack products on November 11, 2025, reports continue to surface that the contaminated formula remains on the shelves of major retailers such as Walmart, Target, Kroger, Acme, Shaw’s, Safeway, Albertsons, and Whole Foods. The FDA, in collaboration with state partners and retailers, is working to ensure the removal of the product, but the persistence of the formula in stores has left many parents anxious and uncertain. The agency has repeatedly warned consumers not to use ByHeart products, even if they appear or smell normal.
Legal action is mounting. At least four families have filed lawsuits against ByHeart, alleging that their babies were sickened by the contaminated formula. Madison Wescott, a mother from Washington state, captured the emotional toll in her statement to NBC News: “Knowing that I can’t fully feed my child, and I can’t trust formula companies has really taken a toll on our family.” In another lawsuit, California parents Anthony Barbera and Thalia Flores described how their son became so weak from botulism he could no longer eat or cry.
The outbreak has not been limited to one region. Texas and California have reported the highest number of cases, but states from Maine to Oregon have also been affected. The infants’ ages range from just over two weeks to nearly nine months, and 38% of those affected are female. According to the CDC, symptoms can take several weeks to develop, making it challenging to trace the source and prevent further cases.
The crisis has prompted renewed attention to the broader issue of infant formula safety. While Clostridium botulinum contamination in formula is likely unprecedented, other pathogens such as Cronobacter sakazakii and salmonella have caused past outbreaks, sometimes with fatal consequences. Experts emphasize the importance of safe handling and storage practices for infant formula—washing hands and surfaces before preparation, cleaning and sanitizing bottles, using safe water, and adhering to expiration dates. Prepared formula should be used within two hours or refrigerated promptly, and opened powdered formula must be used within one month.
For families already affected, the wait can be agonizing. In Reading, Massachusetts, one mother is anxiously awaiting word on her son’s health after he consumed the recalled formula. The uncertainty is shared by many across the country, as the number of cases is expected to rise in the coming weeks. The CDC and FDA continue their investigation, and updates can be found on their respective websites.
As the investigation unfolds and lawsuits proceed, the story of the ByHeart formula outbreak serves as a stark reminder of the critical importance of food safety, corporate responsibility, and the need for vigilant oversight in products designed for the most vulnerable among us.
