When Tony Barbera rushed his newborn son Alessandro to a California hospital in October 2025, he’d barely heard of infant botulism, let alone the rare, painstakingly crafted antidote that would likely save his child’s life. Little did he know, his family’s ordeal would soon become emblematic of a national crisis—one that’s exposing deep cracks in America’s infant formula safety net and sparking urgent calls for reform.
Since August, at least 39 babies across 18 states have been hospitalized with infant botulism tied to ByHeart Whole Nutrition Infant Formula, according to the California Infant Botulism Treatment and Prevention Program and reporting from Food Safety Magazine. The outbreak, which has now ballooned to at least 107 cases of infant botulism treated nationwide, has not only upended families but has also thrown a spotlight on the country’s sole life-saving treatment: BabyBIG.
BabyBIG, licensed in 2003, is a human botulism immune globulin made from the blood plasma of a small group of vaccinated scientists and volunteers. It’s a one-of-a-kind, intravenous medication that harnesses antibodies to neutralize the deadly botulism toxin in infants too young to fight the disease themselves. “This is almost like a miracle,” Dr. Vijay Viswanath, a pediatric neurologist at Children’s Hospital Los Angeles, told NBC News. “Prior to the discovery of BabyBIG, some of these hospitalizations would take two or three months—if infected children recovered at all.”
The origin of BabyBIG traces back nearly half a century. In 1976, Dr. Stephen Arnon of the California Department of Public Health identified the rare form of botulism that targets infants under one year old. He then devoted his 45-year career to developing a treatment. The disease, caused by babies ingesting spores that germinate and release a paralyzing nerve toxin, can be devastating. Before BabyBIG, the odds for afflicted infants were grim.
It took 15 years and $10.6 million to bring BabyBIG from concept to reality, with a pivotal clinical trial in California in 1997 demonstrating that the drug could shorten hospital stays and reduce the need for breathing machines. Since then, more than 3,700 children worldwide have received the treatment. But there’s a catch: BabyBIG is produced only in small batches every five years, with each dose costing nearly $70,000. The process relies on about 30 volunteers per batch, many of whom, like 76-year-old retired biochemist Nancy Shine, were vaccinated against botulism due to their work with the germ in laboratories.
“It was not very pleasant to be vaccinated with,” Shine recalled to NBC News. “There were a lot of side effects, like big welts where you got vaccinated and a little bit of pain.” Still, she considers her plasma donations to be the highlight of her career: “We made a product that could save infants’ lives.”
The latest batch—Batch 8—is currently being manufactured at a Takeda Pharmaceutical plant near Los Angeles, under a not-for-profit contract with California health officials. Some of the earliest plasma donors, like Shine, have now aged out of the program, which only accepts volunteers up to age 70. New donors must enroll in a clinical study and agree to receive a booster dose of a different investigational botulism vaccine.
Despite the lifesaving potential of BabyBIG, the ByHeart-linked outbreak has exposed troubling vulnerabilities in the nation’s infant formula oversight. According to Food Safety Magazine, testing found Clostridium botulinum—the bacterium responsible for botulism—in both opened formula from a sick child’s home and unopened, finished product at a ByHeart production facility. Alarming FDA inspection reports revealed a litany of food safety failures at ByHeart’s Reading, Pennsylvania facility (now closed) and its Fullerton, Iowa plant. Inspectors documented mold, dead insects, leaking roofs, rodent activity, rusty surfaces, and even Cronobacter sakazakii-positive environmental swabs.
Even more concerning, weeks after a recall of all ByHeart formula products, major retailers including Walmart and Target continued to sell the formula, according to the Safe Food Coalition. The coalition, made up of seven prominent food safety and consumer groups, sent a letter on December 9, 2025, to FDA Commissioner Marty Makary, CDC Acting Director Jim O’Niell, and U.S. Health Secretary Robert F. Kennedy, Jr., demanding immediate action to shore up infant formula safety.
The letter, signed by organizations such as the Center for Science in the Public Interest and Consumer Reports, outlined a series of urgent recommendations. These include filling FDA inspector vacancies—currently at a staggering 40 percent—reinstating inspector training, increasing and fully funding inspections (including at the state level), and strengthening regulations around C. botulinum in infant formula. The coalition also called for a more robust recall process, comprehensive environmental monitoring, and new Congressional authority to require formula companies to promptly report positive pathogen test results to the FDA.
“This ongoing outbreak has exposed dangerous deficiencies in the inspection and regulatory systems that should ensure infant formula safety,” the letter stated. The authors argue that these changes are long overdue, especially considering the 2022 infant formula crisis, which was triggered by two infant deaths from Cronobacter sakazakii infection and led to nationwide shortages after the closure of a major production facility.
Although the FDA has since established an Office of Critical Foods and the CDC made Cronobacter a nationally notifiable disease, the coalition maintains that “consumer protections against contaminated infant formula remain woefully inadequate, with infant formula production and packaging facilities typically inspected at most once a year.” The current outbreak has occurred despite incremental changes by both the FDA and CDC, as well as high-profile efforts like Secretary Kennedy’s Operation Stork Speed, which aimed to prioritize infant formula and baby food safety.
For families like the Barberas, the stakes are heartbreakingly personal. Tony Barbera, reflecting on his son’s slow recovery, told NBC News, “It is hugely remarkable.” Meanwhile, for donors like Nancy Shine, the impact is deeply felt: she recently received a booklet full of photos and letters from grateful families. “It’s really wonderful. I read a couple each day. Every single one of them makes you want to cry.”
As California officials estimate that BabyBIG reserves will last until next summer, the nation faces a dual challenge: ensuring continued access to this rare, life-saving treatment and fixing the regulatory gaps that allowed the ByHeart outbreak to happen in the first place. The Safe Food Coalition’s letter serves as a clarion call, urging lawmakers and regulators to act now—before another crisis puts more infants at risk.