Three years ago, America was in the midst of an infant-formula crisis. Abbott, one of the world’s biggest formula producers, had issued a nationwide recall after two children who consumed its products died of Cronobacter, a bacterial infection that can lead to complications such as meningitis. Because Abbott produced about 40 percent of the U.S. supply of infant formula, the recall contributed to a monthslong nationwide shortage stemming partially from pandemic-related supply-chain issues.
Federal investigators suspected that the outbreak originated in an Abbott factory in Michigan. FDA inspectors found that the plant had a leaky roof, standing water, and colonies of bacteria. Abbott has denied that its plant was the source of illness, and its products were never definitively linked to the outbreak. Nevertheless, the incident led to congressional hearings, a consent decree for Abbott, and assurances from FDA officials that the agency would more closely police formula manufacturers so that a situation like this would never happen again.
And yet, it has. Twenty-three infants have fallen ill in recent months from infant botulism after drinking powdered formula from ByHeart, a high-end brand whose stated goal is to “make the best formula on earth.” Infant botulism can cause muscle weakness, difficulty breathing, and, if untreated, death. One child was on a feeding tube for four weeks, according to Bill Marler, a food-safety attorney who filed a lawsuit last week on behalf of the child’s family. Last Tuesday, ByHeart issued a nationwide recall for all of its products.
In response to detailed questions, a spokesperson for ByHeart told me that the company is focusing on “implementing the recall as quickly as possible and supporting the FDA’s investigation into the source of the outbreak.” The company wrote in a November 8 update to customers that “there is no confirmed link between ByHeart’s infant formula and infant botulism.”
Infant formula is perhaps the most highly regulated sector in the U.S. food industry, because the slightest lapse can cause serious harm. Nothing about formula itself is inherently unsafe; it’s essentially milk protein fortified with key vitamins and minerals. But microbes that most adults can ingest without incident—including the ones that caused the 2021–22 outbreak and today’s—can cause life-threatening complications for babies, because the newborn immune system isn’t developed enough to fight them off. The FDA inspects infant-formula plants at least once a year. (Regulators inspect facilities for other foods they deem at high risk of contamination only every three years, unless they’re alerted of a potential problem.)
Missteps in manufacturing happen, but most of the time, they are caught before they end up making kids sick. At least five other infant-formula recalls have occurred because of potential contamination since Abbott’s in 2022. It’s impossible to say that no children got sick from those incidents—parents may simply have not reported their kids’ illness—but in recalling the products quickly, the companies might have prevented major problems.
Although many smaller formula brands use a third-party manufacturer, ByHeart operates its own facilities, so the current outbreak appears to be contained to only its products. And unlike Abbott, ByHeart’s market share is too small—about 1 percent, per the FDA—to meaningfully affect the national supply. Infant botulism is less deadly than Cronobacter, and the condition is rare. The medical literature documents only a few cases that have been tied to infant formula prior to the current outbreak. In 2021, just 181 cases were confirmed in the United States overall.
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Even so, ByHeart’s customers are clearly distressed. On the company Facebook page, parents—some of whom have fed their children the affected products—are venting their anger at the company. “I have yet to sleep in peace since we heard about this,” wrote one mother, who says she fed her three-week-old the formula before the recall. Others are frustrated that they purchased an expensive formula only to throw it all away. (Prior to the recall, ByHeart sold its powdered formula for about $1.75 an ounce; at Target, Abbott’s Similac Advance formula costs about $1.30 an ounce.) ByHeart told me in a statement that “we express our deepest sympathy to the affected families” and that the company is “working as quickly and diligently as we can to respond to each inquiry we receive.”
Experts I spoke with were adamant that food manufacturers bear most of the blame for foodborne outbreaks—after all, they produced the unsafe food. “It is the responsibility of a food company, whether they’re making baby formula or Pop-Tarts or selling romaine, to ensure that their food is safe,” Sandra Eskin, the CEO of the advocacy group Stop Foodborne Illness, told me. But regulators often share some culpability. In the 2021–22 outbreak, a whistleblower alerted the FDA to alleged rule-breaking, including falsification of records and the release of untested formula into the market, but regulators failed to follow up on the complaint until 15 months later. Abbott said in a statement on its website that the whistleblower “was dismissed due to serious violations of Abbott’s food safety policies, and after dismissal, through their attorney, made evolving, new and escalating allegations to multiple authorities.” Although the company has acknowledged that the plant at issue did test positive for certain bacteria, a spokesperson reiterated the company’s defense to me that it was never proved that the bacteria in its facility made it into formula.
As for the current outbreak, it’s too early to pinpoint exactly what went wrong. The affected powdered ByHeart formula must be rehydrated, so the bacterial spores that cause infant botulism—which are relatively common—could have contaminated the formula when parents were preparing it for their babies. But experts told me that that explanation is unlikely because so many children have now gotten sick from the same formula; nearly two dozen families would have had to make the same mistake around the same time. Plus, the FDA found manufacturing deficiencies at ByHeart’s Iowa facility—one of the two linked to the current outbreak—when it was last inspected in February, Emily Hilliard, a Department of Health and Human Services spokesperson, told me. (She declined to say what those deficiencies were.) The ByHeart spokesperson, when asked about the issues identified in February, said that “addressing observations and updating regulators is a continuous and routine process that is inherent in maintaining compliance and meeting the highest safety and quality standards.”
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In 2023, the company received a formal warning letter after the FDA found that the company did not have proper systems in place to make sure that formula was not contaminated at its since-closed facility in Reading, Pennsylvania. Months later, that facility was cited by the FDA for having mold in a water tank and thousands of dead insects on the premises, according to The New York Times.
The spokesperson for ByHeart told me that all of the issues in the 2023 warning letter have been resolved. But the FDA’s allegations against the company typify what food-safety experts and former FDA officials have described to me as ByHeart’s cavalier approach to food safety. “There’s a lot of red flags about the way ByHeart is managing this outbreak, which tells me they don’t have an experienced food-safety team at the helm,” Sarah Sorscher, the director of regulatory affairs at the Center for Science in the Public Interest, told me.
The company has, for example, downplayed findings by officials at the California Department of Public Health, who tested an open canister of ByHeart formula acquired from an infant-botulism patient and found the bacteria that causes infant botulism. After California alerted the public to these findings on November 8, the company announced a recall and put out a statement claiming that it was taking the results “very seriously”—but then questioned the state’s methodology in the next sentence.
In an open letter posted on the company’s website, ByHeart also noted that formula companies are not required to test for the bacteria that causes infant botulism. Frank Yiannas, a former deputy commissioner for food policy at the FDA, told me that the response was “not a really good answer,” because companies—particularly those in an industry like infant formula—should be doing their own analyses of hazards and risks, regardless of what is mandated by law. When California’s officials found the bacteria in that can of baby formula, the state’s public-health officer urged parents to “stop using ByHeart formula immediately.” The company, however, initially responded by recalling just two batches of its formula. (In the days since, the company has issued a nationwide recall to include all of its products.)
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In the coming weeks or months, regulators may find—as they did with Abbott—sanitation issues at ByHeart’s facilities. Or perhaps the evidence will indicate that the company acted responsibly and just got hit with a black-swan event. Whichever way the situation goes, it’s a reminder of how easily the baby-formula industry can crack, even when it’s supposed to be bulletproof.