These babies are still sick after botulism outbreak. But how did it get into infant formula?

Angel Carter had breastfed her baby, Ashaan, exclusively from the day he was born. But last November, when Ashaan was 9 months old, it was time for Carter to transition her son to a sippy cup. An Oregon Department of Human Services caseworker suggested that Carter, a single mother receiving state assistance, try ByHeart infant formula because it was “the closest thing to breast milk,” Carter recalled. Within a week, baby Ashaan, an active, babbling little boy, had changed. He was no longer making eye contact, instead staring off into space for 30 minutes or longer. He stopped being interested in food and wouldn’t even latch on to nurse. Once able to stand and take steps, Ashaan no longer had the strength to sit upright. His skin became a sickly color. “He was turning grayish blue. He looked like a faded picture of himself,” Carter, of Portland, said. “His eyes rolled into the back of his head, and I was like, ‘Oh my God, my baby is dying.’” Ashaan’s symptoms were classic signs of botulism. The toxin blurs vision and blocks nerves from telling muscles to contract, leaving babies floppy and constipated. Their mouths lose the ability to suck from a bottle and swallow liquids. Doctors told Carter they needed to move quickly. “Without the right help, he could die,” she said they told her. “A chaplain even came to the hospital room.” On Nov. 11, as Ashaan’s medical team was scrambling into action, New York-based organic formula maker ByHeart and the Food and Drug Administration were issuing a nationwide recall of all ByHeart infant formula products. It was the first botulinum toxin outbreak ever associated with baby formula, a feeding alternative used by millions of parents. In all, 48 babies in 17 states with confirmed or suspected botulism linked to the formula were hospitalized during the outbreak. No deaths were reported. Most babies recovered, but a lawyer representing affected families said that at least six are still suffering from lingering effects of the toxin, which can cause difficulty breathing, muscle paralysis and death. Seven months later, Ashaan, who turned 1 in February, still can’t eat on his own. He has a gastrostomy tube, or G-tube, surgically implanted through his belly into his stomach for supplemental nutrition. “He’s just now to the point where he will suckle on something until it melts in his mouth enough for him to swallow it,” Carter said. By the time the outbreak was declared over in February, an FDA investigation found Clostridium botulinum in a powdered milk ingredient used in ByHeart infant formula. The bacterium that causes botulism can grow in foods that aren’t properly canned or preserved. It’s very rare for store-bought foods to be contaminated with the toxin. How the bacteria got in the infant formula remains a mystery. A second, separate outbreak linked to baby formula is now under investigation. On June 13, Nara Organics of New York recalled all of its Whole Milk Organic powdered formula after three babies who had consumed it developed botulism. Testing so far has not detected the bacteria in Nara’s products. There’s no indication the outbreaks are related, but food safety experts are alarmed over back-to-back botulism-related recalls involving infant formula. “We are no longer talking about a single event,” Darin Detwiler, food policy professor at Northeastern University, wrote in an email. “We are talking about a pattern.” Detwiler’s son died in a multistate outbreak of E. coli linked to contaminated fast-food hamburgers in 1993. In an email, an FDA spokesperson said it’s too soon to draw conclusions about any specific ingredient, manufacturing process or other contributing factor in the Nara investigation. Both companies said they are cooperating with health officials. ByHeart and Nara Organics products account for a small fraction, about 1%, of the U.S. formula market, according to the FDA. Infant nutrition experts said the country’s supply is overwhelmingly safe. “I don’t want families to think that this is something we expect to see in all powder formulas,” Dr. Sharon Nachman, chief of pediatric infectious diseases at Stony Brook Children’s Hospital in New York, said. “But to have two outbreaks come so close to each other with the same pathogen is quite worrisome.” Monthslong recoveries A yet-to-be-published report from the Centers for Disease Control and Prevention illustrates the severity of infant botulism, even after babies are released from the hospital. Recovery can be extremely slow, as it involves the regeneration of the signaling pathway between nerves and muscles, a process that can take months. Myra Brooks, an epidemic service intelligence officer with the CDC, reviewed medical records for 46 of the 48 babies in the ByHeart outbreak. None of the children had a fever that would indicate a different cause for their illness, like a virus. Other symptoms were key. Of the 46 babies: - 91% had problems with their sucking reflex - 87% were constipated - 76% couldn’t hold their heads up - 24% had trouble breathing More than half of the babies, 61%, needed extra oxygen to help them breathe or be fed through tubes in their noses. Eleven percent had to be intubated or have a feeding tube surgically placed in their stomachs. Two-thirds of the infants needed special therapy to retrain their mouths to eat, Brooks said. Her findings are expected to be published in one of the CDC’s upcoming Morbidity and Mortality Weekly Reports. For Brooks, the results of the CDC report were reassuring. “Most infants make a complete recovery from this disease,” she said. A rapid decline It’s been more than a year since Hank Mazziotti, now just shy of age 2, was hospitalized with infant botulism. He still can’t move his bowels without the aid of laxatives, his mother, Amy, said. “It’s so painful for him that he’s throwing up and pooping at the same time,” she said. “That’s a weekly thing.” Amy Mazziotti said she bought a can of ByHeart in mid-February 2025 because she needed to supplement her breast milk supply. The formula was advertised as being made in small batches and the closest thing to breast milk. “They had good marketing, to be honest,” she said. Hank’s constipation began within days. By early March, the 6-month-old — who’d just discovered how to roll over and was doing so nonstop — stopped performing his new trick. He barely drank from his bottle. His head flopped to one side. “His condition declined rapidly,” Mazziotti said. “He couldn’t move. He couldn’t even cry. His whole face was just paralyzed.” The search for answers Tests conducted by the FDA found Clostridium botulinum in ByHeart formula as well as in a powdered milk ingredient that came from ByHeart’s milk supplier, Dairy Farmers of America, a cooperative based in Kansas City, Kansas. The agency hasn’t determined how the bacteria got in the ByHeart samples but is continuing to investigate factors related to ingredients, methods of processing and production environments, according to a spokesperson. After the ByHeart recall, the company gave its customers a discount code for Nara Organics, a ByHeart spokesperson said in an email, to help families transition to a similar product. The companies are separate “with no corporate, financial, contractual, operational, or manufacturing relationship,” the spokesperson wrote. A spokesperson from Nara Organics referred to an Instagram post from last week by company founder Esther Hallam, who reaffirmed that none of the products had tested positive for Clostridium botulinum and that the company voluntarily recalled its products “out of an abundance of caution.” The post also touted Nara Organics’ use of a type of testing, called SRC, that can detect bacteria, but not necessarily Clostridium botulinum. It’s not required by the FDA. “Families often have a confused idea that formulas that are organic, that are more expensive, that advertise on social media, are somehow safer than other formulas,” Dr. Steven Abrams, a neonatologist and professor of pediatrics at the University of Texas at Austin, said. “There’s no evidence for that,” he said. “All formulas go through the same safety processes.” The formula recalls occurred several months after the Department of Health and Human Services, under the direction of Robert F. Kennedy Jr., announced “Operation Stork Speed,” a program intended to review the safety of ingredients in infant formula and focus on testing for heavy metals and other contaminants. “While infant botulism associated with infant formula remains extremely rare, every case is one too many,” Emily Hilliard, an HHS spokeswoman, said in an email. “That is why the FDA is expanding testing, strengthening surveillance, and accelerating scientific work through Operation Stork Speed to better understand risks and further strengthen safeguards across the infant formula supply chain.” Northeastern University’s Detwiler said he’d like to see more of an emphasis on prevention and increased surveillance of infant formula before, not after outbreaks occur. “When the same rare illness appears twice within months, involving products intended for infants, the question is no longer whether this can happen,” Detwiler said. “The question is whether we will finally learn enough from the warning signs to stop the next child from becoming the next statistic.” Clostridium botulinum is everywhere. Why do babies get sick? It’s possible that unsafe farming practices played a role in the botulism outbreaks, as bacteria that cause the illness can be found naturally in soil and water, food safety experts said. Most people can consume food or drink with the bacterial spores without a problem thanks to a robust and mature digestive system. Babies under age 1, however, have an immature gut that doesn’t have the ability to fight off those spores. It’s why infants aren’t supposed to eat honey, for example, which can be likely to harbor Clostridium botulinum. Left alone, the spores can produce a neurotoxin that spreads in the body, causing botulism. About 100 to 200 cases of infant botulism are reported each year in the U.S., according to the CDC. Pacifiers filled with honey have previously been implicated in some illnesses. Andi Galindo knew about the link between honey and botulism, which is why she initially dismissed botulism as a possibility when her daughter, 5-week-old Rowan, got sick in December 2023. An emergency room doctor suggested a botulism diagnosis based on Rowan’s symptoms: the baby’s eyes were vacant, she’d stopped being able to hold her head up, she could barely finish a bottle. “I would never give a 5-week-old honey,” Galindo said. “It couldn’t be that.” Galindo had given Rowan ByHeart infant formula when she had trouble breastfeeding. “I wanted to do my due diligence and choose a very clean, healthy formula, the best thing I could possibly find,” she said. The only approved treatment for infant botulism is called BabyBIG. It’s an IV medication made from the plasma from adults immunized against botulism. Most donors are scientists whose work with Clostridium botulinum requires vaccination. BabyBIG is produced by and made available through the California Department of Health’s Infant Botulism Treatment and Prevention Program. It doesn’t reverse the damage done by the botulinum toxin, but it can stop it from wreaking more havoc and shorten the baby’s recovery time. It costs nearly $70,000 per treatment. Families have to decide quickly whether to get it, even if infant botulism is only suspected. Test results aren’t quick, which is why doctors are trained to look for other clues and symptoms to make a diagnosis of infant botulism. All of the babies in the ByHeart outbreak — regardless of whether their illness was confirmed through testing — had to get BabyBIG. It’s “absolutely lifesaving, but you have to agree to it weeks before you actually know if it’s botulism, because it takes so long for those bacteria cultures to grow,” Galindo said. “That’s the first experience I’ve ever had with having to agree to a big medication, not knowing if it would be covered, not knowing if it was going to help her.” Rowan was hospitalized for nearly a month and underwent physical and feeding therapy after she was discharged. Now 2 years old, Rowan runs and plays and acts like a typical toddler. Still, Galindo said, “it was a very long, very slow road to recovery.” She, Carter, the Mazziottis and other affected families are suing ByHeart. The road ahead Ashaan Carter will undergo an additional surgery in July to transition him to what’s called a G-button, a similar, smaller device that will free him of long, dangling tubes. The word “mama” hasn’t returned to Ashaan’s lips, but he’s cooing again. He’s relearning to walk despite a left leg that’s still weak and requires ongoing physical therapy. “He has a great spirit,” Angel Carter said. “He’s just now starting to reload, to become something again.”