The first thing to know is that the baby is all right now. She’s coming up on her second birthday, playful and curious. She chases the family dog around the house, trying to give him kisses, and mimics her dad by wiggling her hips as he shows her how to hula hoop.
But her home holds a few clues to her past. An oddly huggable orange stuffed animal shaped like Clostridium botulinum, the bacteria that causes botulism. And enshrined in plexiglass, a bottle of BabyBIG, the antitoxin treatment that saved her life when she was 7 months old.
Katie Connolly’s daughter, M., was among the dozens of babies who became sick with infant botulism after drinking contaminated infant formula from ByHeart last year. (The children in this story are identified by their first initials in order to keep their health records private.) Last weekend, another formula brand, Nara Organics, was linked to three new cases of infant botulism by the Food and Drug Administration.
“You buy a product that you think is going to be safe for them, and it ends up putting them in the hospital,” said Connolly. She initially chose ByHeart because she was drawn to its “organic, natural direction.” But one morning, her daughter woke up unable to lift her head or move her arms and legs — a sign of the encroaching paralysis caused by botulism, which can leave infants unable to breathe as it progresses. M. spent nearly a week in the hospital.
Today, Connolly is pregnant with her second child and anxious about the possibility she could have to use formula again. “I definitely operate with extra caution,” she said.
While infant formula in the U.S. has a good overall safety record, the stakes are incredibly high if something goes wrong. Food safety experts who spoke with STAT say they want regulators and the industry to take even stronger measures to prevent disease outbreaks that put babies’ lives at risk. And they want consumers to be wary of marketing from newer, high-end formula companies like ByHeart and Nara that position their products as safer than other options.
“I think a lot of parents can be confused and think that if they spend more money on a formula, it’s safer,” said Steven Abrams, a professor of pediatrics at Dell Medical School at the University of Texas at Austin. In fact, formulas are remarkably similar to one another because they’re required to use a blend of 30 ingredients necessary to give babies the nutrition they need. All formulas are also subject to annual FDA inspections and requirements to test for the pathogens salmonella and Cronobacter.
Of designations like organic, GMO-free, or added probiotics and prebiotics, Abrams said, there’s no evidence that such features “have the slightest health effect on babies.”
Nara and ByHeart were both manufacturers “claiming to produce a healthier type of infant formula because they were using whole milk,” said Frank Yiannas, a former deputy commissioner for food policy and response at the FDA. The fact that both brands have been linked with infant botulism, he said, suggests that “reformulating powdered infant formula should be done with extreme due diligence and caution.”
The FDA told STAT that its investigation into the Nara outbreak is underway, and it’s still investigating the root cause of the ByHeart outbreak, assessing the supply chain and production environment as well as dairy-based ingredients. So far it has matched Clostridium botulinum, or C. bot, isolates from the organic whole milk powder supplied to ByHeart with samples from closed cans of formula and affected infants. It’s not clear how the contamination of ByHeart’s whole milk powder, made by Organic West Milk and processed by a Dairy Farmers of America plant, occurred.
“The FDA is also working with a range of partners all over the world to better understand the risks associated with Clostridium botulinum in infant formula to inform future monitoring and mitigation measures,” a spokesperson for the agency told STAT. Understanding the latest science on spore-forming pathogens like C. bot is “a priority for the FDA.”
Yiannas said it’s important for the FDA to determine the root cause so it can provide guidance to manufacturers on what steps to take to minimize the risk of C. bot. Historically, C. bot has been rarely found in formula, and companies are not currently required to test for it. “It might be a combination of things like formulation, but there might be other on-farm interventions that can be taken to minimize [risk], or in the manufacturing of the product itself,” he said.
But the FDA may not be in a good position to get to the bottom of the outbreaks, according to Sarah Sorscher, director of regulatory affairs at the Center for Science in the Public Interest. She said that over the past year, the agency has been “pummeled by a hostile administration that cut support staff, pushed out veteran experts, and eliminated advisory committees that could have provided the agency’s access to outside scientific guidance.”
No deaths from either outbreak have been reported. But consumers’ concerns about the overall safety of the supply are mounting after these incidents, along with international recalls linked to the contaminant cereulide (including the recent recall of formula brand a2 in the U.S.), memories of the 2022 Cronobacter outbreak linked to the deaths of two babies, and broader concerns over how federal budget cuts could affect the government’s ability to safeguard food.
On Reddit forums and social media, parents share their worries over the products’ safety and compare notes. “We liked that [Nara] was made in Germany where we thought they have stricter regulations and the organic whole milk made us feel like we weren’t skimping on healthy fats,” reads one recent Reddit post from a parent affected by the Nara recall. “Now we feel like naive schmucks.”
Botulism and the ‘whole milk hypothesis’
One widely acknowledged problem with the infant formula industry is that just four companies (Abbott, Mead Johnson, Nestle, and Perrio) dominate 90% of the U.S. market. That exacerbates both the potential reach of food safety issues and the risk of shortages, as was the case with the devastating run on formula back in 2022 in the wake of Abbott recalls.
So experts in infant nutrition generally support getting new entrants into a highly concentrated field. Along with ByHeart and Nara, the past few years have ushered in competitors like Bobbie, the European brand Kendamil, and most recently, Little Spoon — all geared toward upscale, health-conscious parents, the type likely to frequent farmers markets and scrutinize ingredient lists on food packaging.
These companies have frequently tried to distinguish themselves from larger brands by emphasizing the safety and quality of their ingredients. Nara touts its clinical trials and European-manufactured bona fides, while ByHeart pushed its “clean ingredients” and patented protein blend meant to mimic breast milk. (Ironically, ByHeart even directed customers to Nara during its recall last year, with Nara offering a 20% discount.)
Significantly, both Nara and ByHeart tried to differentiate their products by using organic whole milk powder, as opposed to the usual nonfat milk powder that prevails in the U.S.
The whole milk powder connection may turn out to be a coincidence. Abrams said it’s been commonly used in European formulas for decades, and that the FDA needs to do more analysis before anyone draws conclusions. But to Sorscher, it’s a “red flag” that requires urgent scrutiny.
“To me, the key question is, has anyone ever conducted a risk assessment for botulism” in whole milk powder, said Sorscher. Manufacturers must seek FDA approval of new formula products, and Nara and ByHeart both submitted notices to FDA supporting the safety of the whole milk powder ingredient, but neither assessment included information on botulism risks.
“It’s tough because we do want more competition,” said Sorscher. “But there are all these hurdles that come with scaling up and making sure you’re doing all the right things on food safety.”
A call for industry guidance
Several experts noted that the Trump administration in 2025 disbanded the advisory committee on microbiological hazards to the food supply right before it was due to release its report on Cronobacter in infant formula.
That group, the National Advisory Committee on Microbiological Criteria for Foods, would have presumably been the one to look into C. bot, too.
“[O]bviously with ongoing issues for infant formula it would be advisable to reconstitute the NACMCF Committee so that all manufacturers could benefit from the latest science on pathogens like C. bot,” Susan Mayne, a former director of the FDA’s food safety center, said via email.
An international group of experts on a committee jointly run by the World Health Organization and Food and Agriculture Organization is currently conducting a risk assessment on spore-forming pathogens like C. bot in infant formula. Although the U.S. pulled out of the WHO under the current Trump administration, the FDA told STAT that it’s watching to see what the expert group concludes and for any advice on strengthening control measures.
For now, it’s “a huge problem that FDA doesn’t have any guidance yet for industry on how to prevent this risk,” said Sorscher.
How safe is infant formula in the U.S.?
The news of the outbreaks come amid health secretary Robert F. Kennedy Jr.’s “Operation Stork Speed,” an initiative announced before the Nara and ByHeart outbreaks that promised to take a closer look at the nutritional content of formula ingredients (including things like seed oils) and work on avoiding supply issues. This spring, the FDA also tested 16 brands for contaminants like heavy metals, pesticides, and “forever chemicals,” or PFAS, with what experts characterized as encouraging (though not perfect) results.
Yiannas said the administration’s language around the safety of the formula supply chain this spring struck him as too definitive. The FDA should have clarified that its look at 312 samples is still a relatively small sample size, and that it was focused solely on chemical hazards. “The biggest hazards in the powdered formula supply chain right now may not be chemical,” but microbiological, he said.
That’s not to incite panic among consumers, said Yiannas, who was at the FDA during the Cronobacter outbreak. Rather, he said it’s helpful to think about risk as “a function of probability and severity.” Flying in an airplane, he said, is low risk, but the severity of a potential crash is high. “Just like we expect airline manufacturers to take safety measures that address [risk], we should expect food manufacturers to take safety measures and address” the risk of botulism, he said.
Yiannas noted that unlike liquid formula, powdered infant formula is not sterile. This puts parents worried about the possibility of botulism in a hard place. But if exclusive breastfeeding or liquid formula aren’t options, Abrams offered some reassurance.
“I don’t know of any other product out there, including buying vegetables at your local grocery store, that has the safety record that infant formula does in the United States,” he said. “When people talk about the alternative, which would be things like homemade formula or cow’s milk, none of those are likely to be even close to being safe.”
With two-thirds of babies in the U.S. consuming some formula in their first year of life, infants who fall sick are extreme outliers. But, as Connolly said, “Each of these families has their own individual story, and each of these babies has their own individual life.”
Another such baby sat on the floor of a London apartment one recent afternoon, playing with his mom, Anit Joseph. At 9 months old, his dark hair fell in a fringe across his forehead, and he bounced on her lap with his mouth open in gummy delight.
Like Connolly, Joseph decided to use ByHeart formula because it was advertised as organic, with whole milk, probiotics, and prebiotics. Her baby wound up spending 10 days in a Houston hospital, intubated in case he stopped breathing on his own. At one point, she said, a nurse accidentally gave him a fentanyl dose 10 times larger than ordered.
“He’s OK now, but there’s a lot of stuff that we had to go through after,” Joseph said over Zoom, speaking with a slight Texas twang. The baby went to physical therapy because he wasn’t able to lift his head as well as he had before, and he still struggles with constipation.
“I do worry sometimes,” she said. Her baby can sit up and roll on the floor, but he’s not crawling yet. “Sometimes I wonder, is it just because it’s him, or because of all the stuff that he’s gone through?”
Correction: An earlier version of this story mischaracterized the risk assessments submitted by Nara and ByHeart to the FDA. The companies did submit data supporting the safety of the whole milk powder.
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