How Deadly Bacteria Spread in a Similac Factory and Caused the US Formula Shortage

Aug 24, 2022

Procedures got sloppy at the facility in Sturgis, Mich. Cronobacter bacteria proliferated. And when the FDA finally acted, America found itself in a desperate scarcity.

About 20% of the infant formula produced in the US comes from a plant on the edge of the city of Sturgis, in southern Michigan, where it’s been a presence for more than five decades. It’s owned by Abbott Laboratories and makes Similac, the country’s most popular brand. On a September morning in 2021, two US Food and Drug Administration investigators arrived for an annual inspection that was a year overdue because of the agency’s Covid-19 restrictions. When they reviewed company records, they saw evidence of Cronobacter sakazakii, bacteria that can survive for months, sometimes years, in powdered formula and cause devastating illness in infants.

Abbott’s routine testing had turned up cronobacter at the plant five times in the previous two years, which isn’t unusual for a formula maker. More concerning, the bacteria had twice made its way into the formula itself, in cans ready for distribution. Abbott held back the cans in those batches but didn’t recall any others. The company wasn’t required to notify the FDA, and it didn’t. Abbott was expected to fix whatever may have allowed the contamination and said that it had. Yet the inspectors watched as a worker reached into a bag containing an essential ingredient without cleaning his gloves or hands—just the kind of sloppiness, they noted, that could spread cronobacter from work surfaces to the powder. They found more to fault: crucial drying equipment with a history of pits and cracks where cronobacter could hide; pooled water where it could multiply.

On day one of the five-day inspection, the FDA received a report about an infant in Minnesota who’d been hospitalized for three weeks with a cronobacter infection. The infant had been fed Similac Sensitive made in Sturgis. On the second day, someone at the FDA told someone at Abbott about the case. But no one at the FDA or Abbott ever told the inspectors. Despite the troubling conditions they had seen, no alarms went off, no red flags were raised. There would be no recall, no shutdown, not even a warning. Instead, as it often does, the agency relied on the company to fix the problems on its own.

The complaints and alerts kept coming. In October a former employee in the Sturgis plant filed a whistleblower report with the FDA, alleging that an emphasis on productivity sometimes compromised safety, violations of all sorts were hidden, and a culture of permissiveness for some was known to all. The document reached a few at the agency, but copies sent to the most senior officials were, according to the FDA, lost in the mailroom. During the next several months, three more infants who’d been fed formula made at Sturgis were infected. Two died, and another, a boy in Texas, appeared so close to death that a priest came to give him last rites.

The boy’s mother, Jane Hernandez, hasn’t spoken publicly about the experience before and doesn’t want her son’s name known. He fell ill a week after he was born. The cronobacter caused meningitis and encephalitis and inflammation in his kidneys. The right side of his brain is damaged, but it’s too soon to know how severely. He’s under the care of an early intervention specialist, a neurologist, and an infectious disease doctor. He’s now 8 months old.

The company failed to prevent the spread, the regulator missed it, and the consequences are accumulating

When inspectors returned to Sturgis at the end of January—four months after their initial visit, three months after the whistleblower’s report, one month after they finally interviewed him—they found five different strains of cronobacter. Abbott’s own tests, conducted in February, detected cronobacter 20 times. The commissioner of the FDA, Robert Califf, later told members of the US House of Representatives that the conditions at Sturgis were shocking: “Let’s say you had a next-door neighbor who had leaks in the roof, they didn’t wash their hands, they have bacteria growing all over the kitchen. You walked in, and there was standing water on the counters and the floor, and the kids were walking through with mud on their shoes and no one cleaning it up. You probably wouldn’t want your infant eating in that kitchen. And that’s in essence what the inspection showed.”

Some 70 million cans and containers of Similac, as well as the specialty formulas EleCare and Alimentum, were recalled in mid-February. Sturgis stopped production. The shutdown created a new problem: a nationwide shortage of powdered infant formula. The industry, many soon learned, is so concentrated that there are only two other major manufacturers— Mead Johnson and Gerber Products—and they couldn’t make up the loss. Parents, especially those whose infants needed the specialty formulas, panicked. Even when the other companies increased production and the FDA loosened import restrictions, the shortage persisted.

Within a few weeks, the agency received more than a hundred complaints about Abbott’s formulas. Seven infants had died; others were sick with salmonella; infants were vomiting, and had diarrhea, stomach aches, and fevers.

The FDA closed its investigation of the four cronobacter cases in mid-May. It said the evidence doesn’t rule in or rule out a definitive link between the infant deaths and illnesses and the formula produced at the plant. Abbott chooses to emphasize the former. It says the cronobacter strains found in the only two samples available from the infants don’t match those found at Sturgis and don’t match each other, and that no cronobacter was found in two of the three samples of opened formula that were tested.

Days later, Abbott entered a five-year consent decree with the US Department of Justice that gives the FDA extraordinary oversight of the Sturgis facility. A court document describes the company and three managers as being “unwilling or unable to implement sustainable corrective actions to ensure the safety and quality of food manufactured for infants.”

More than two dozen families have sued Abbott for product liability, fraud, and negligence. Abbott says it’s “very sympathetic” to the families but believes “these suits are without merit.” The FDA is under investigation by the Office of Inspector General for the US Department of Health and Human Services. At Sturgis, the company failed to prevent the spread of a pathogen that’s been known for decades to imperil infants, the regulator missed it, and the consequences are accumulating.

Sturgis, a city of about 11,000, sits on the border with Indiana. Once a prairie, its soil is still fertile; once dependent on the railroads passing through, it’s now home to several manufacturers. In 1924 a Harvard biochemist and a Boston pediatrician sold their infant formula recipe—a blend of cow’s milk, vegetable oils, calcium, and phosphorus salts—to Moores & Ross Milk Co. in Columbus, Ohio. The formula was eventually named Similac, as in “similar to lactation,” and by the late 1940s it was the most popular infant formula in the US. That’s when Sturgis offered M&R a deal: 11 acres of vacant land for $3,000. The company began producing Similac there in 1949.

The next year a strain of cronobacter was first isolated in a tin of dried milk. As scientists worked to understand its prevalence and virulence, doctors reported finding it in sick patients, often infants who’d been fed powdered formula.

Cronobacter cells are motile, rod-shaped, opportunistic. They can exist in wheat flour, corn starch, herbal tea, soil, dust, and water, but dried milk and powdered infant formula are their favorite places to hide. Scattered and desiccated, the cells can survive for up to two years. When adults encounter cronobacter, the bacteria have usually been killed by heat—the water for the tea has been boiled, the flour’s been baked—and their immune systems offer protection. Even so, adults can get sick with diarrhea and urinary tract infections. When babies encounter cronobacter, their immune systems are immature and their digestive tracts vulnerable, and the bacteria in the powder is often still alive. The water added to it most likely hasn’t been boiled, and at room temperature it will stimulate the cronobacter. The cells can divide quickly, doubling in number in 20 minutes. They can escape the stomach, enter the bloodstream, and damage the brain. Infected infants can develop sepsis, abscesses, and meningitis, and if they do, about half the time they die. Cronobacter was named after Cronus, the Titan of Greek myth who devoured his children as they were born.

When Abbott bought the infant formula facility in 1964, it became a big employer in a small town. Abbott, whose headquarters are in suburban Chicago, is the largest taxpayer in Sturgis and the one with the most prominent name. The plant is the kind of place where people know one another from someplace else, where it’s possible to meet and divorce two spouses, to have your new partners and ex-partners as colleagues, to have children, siblings, and in-laws there, too. People often mention that Abbott has employed four generations of one family.

We contacted more than 80 current and former employees over four months. Some who’d retired were surprised at the trouble at the plant; others didn’t believe it or blamed the FDA. Most didn’t want to talk about it, and even those who’d left seemed fearful of repercussions if they did. They didn’t want to ruffle any feathers or draw any attention.

The goal for many hired when they were young was to stay until they could retire, 55 and out. Lots managed to do that, and they almost all say the same thing about their years at Abbott: They worked hard, and the company treated them well. Abbott offered good wages, a 401(k), health insurance, even stock grants for some, and it expected people to work overtime, often seven days a week, and, of course, to keep the production lines moving. One employee was asked to put in extra hours his last few days on the job. He did. “I figured I owed them that,” he says. Abbott says everyone at Sturgis knows how important their work is.

In 2001, five decades after its discovery, cronobacter caught the attention of the nation’s food safety regulator and the companies it regulates. In April of that year, at a university hospital in Knoxville, Tenn., an 11-day-old boy, born prematurely and weighing less than 3 pounds, fell ill with cronobacter. He had a fever, an accelerated heart rate, and sepsis. When his brain stopped functioning, his family took him off life support, and he died nine days later. Eight other infants in the unit were also infected: Three recovered; the others never got sick. One potential source of the cronobacter was the infants’ one common source of nutrition—Portagen, made by Mead Johnson. Almost a year after the newborn’s death, the company recalled 17,000 cans of the formula. The FDA recommended that neonatal intensive care units stop using powdered formula altogether: There’s no way to make it sterile. Liquid formula is sterile, but it’s also more expensive.

To try to assess the risks, the agency collected powdered infant formula samples from different manufacturers. Five of the 22 were tainted with low levels of cronobacter. In 2003 officials briefed doctors and industry representatives about this seemingly new pathogen. “You can always design something a little better or clean something a little better,” an FDA official said. “Things come along, and we’re required to raise the bar. I mean, were it not for the Titanic, would we have life preservers on cruise ships?” Some in the industry suggested that, given the infrequency of cronobacter infections, the agency was overreacting.

Cronobacter infections are rare. They’re also not always identified or reported. Minnesota is the only state to require doctors to notify health officials of infected patients. The Centers for Disease Control and Prevention says that four to six infants are sickened by cronobacter every year, but some researchers estimate that as many as 18 might be. Minnesota alone identified three cases in the past five years.

Soon after that 2003 meeting, the agency began what would turn into a decade-long negotiation with manufacturers about a testing protocol for cronobacter. Former employees at Sturgis recall learning about the bacteria back then and their relief that public scrutiny fell first on a rival.

In 2010, Sturgis had to contend with a different problem. At a meeting to review consumer complaints, supervisors showed pictures of a trail of flour beetles in a can of formula. “They said they didn’t think it came from the plant,” a former employee recalls. “Quite a few of us said we suspected it might have.” The FDA determined that beetles were in the hopper room, the main warehouse, and the basement, and in some cases had been there as far back as 2007. “It should have been addressed properly right away,” another former employee says. “Sturgis is a long way from Chicago. I’m sure they wanted to keep it at Sturgis and hoped it would somehow pass.”

Abbott recalled 5 million containers of Similac and stopped production. The FDA said there was no immediate health risk for infants, but they might refuse to eat if small insect parts or larvae were irritating their digestive tracts. “It was bad and disgusting and upsetting to all of us,” a former employee says. “But it wasn’t bacteria. No one was going to die.”

The facility was steamed, cleaned, and scrubbed; bushes were removed; the windows and siding were replaced. No one was allowed to prop open doors anymore. Later, in a call, Miles White, the chief executive at the time, reprimanded some Sturgis employees. The plant manager was replaced but remained with the company.

The recall would cost Abbott $100 million. Six months later, Similac was again the bestselling formula in the US.

Cronobacter still threatened, and investigations still rarely concluded with a definitive link. Two infants who’d been fed Enfamil, made by Mead Johnson, were infected and died in late 2011. Walmart stopped selling the formula, and other retailers followed. The FDA said it couldn’t be sure of the source of the pathogen, and they all put Enfamil back on their shelves. In 2017 two more infants died, and the agency reported finding cronobacter in Mead Johnson’s plant in Zeeland, Mich. The FDA says it didn’t shut down the facility or push for a recall because it didn’t believe the product was in the US marketplace. “Our products have not been a confirmed cause of consumer illness since the early 2000s,” a spokesperson for Mead Johnson says.

Proving beyond doubt that cronobacter in a can of opened formula came from a factory, and not from the infant’s home, can be complicated. If there’s cronobacter in a production facility, there may be more than one strain. Some may be transient. Some may have colonized, settling in where they can avoid detection and destruction. It’s possible to find a strain, or several, in a factory and to find a different one in the formula—or the sick baby. That might mean there’s no link, but it might also mean the matching strain exists, or existed, in the factory and no one found it. “This is just something where the two pieces of the puzzle don’t connect,” says Séamus Fanning, a professor at University College Dublin who studies cronobacter.

A sample test could easily come back negative even though the infant got sick. Powdered formula is made up of millions of small grains, and not every grain will be tainted. Cronobacter doesn’t uniformly contaminate a can. It could be in the top and not the bottom. This makes finding the bacteria difficult and leaves many experts describing the search for it the same way: like looking for a needle in a haystack.

He arrived at Sturgis in 2015, a couple of years out of college, with a good recommendation from a prior job at Monsanto Co. He started as many do, as a contractor paid an hourly wage, and was soon moved to the quality assurance department, given more responsibility, and put on salary. According to his annual performance reviews, he took initiative, sought feedback, and kept a positive attitude. Twice he was rated “Best in Abbott” for delivering results. In 2019 his supervisor wrote that he was “not afraid to step forward and raise concerns as necessary keeping quality at the forefront.” She noted that he helped win an international award for the plant. She also said he should improve his communication skills, citing a string of emails whose tone she called more accusatory than collaborative.

The whistleblower wishes to remain anonymous and, through his lawyer, declined to comment for this article. But given the circumstances, many at Sturgis know who he is. One retired worker suggested he watch his back. Abbott says he’s a disgruntled former employee who’s continued a pattern of ever-evolving, ever-escalating allegations that are unfounded and don’t correlate to the FDA’s inspection observations.

His complaint to the FDA was released by Representative Rosa DeLauro (D-Conn), a strong critic of the agency, in April and is cited in several lawsuits filed since then. Through a public records request, Bloomberg Businessweek obtained two other documents that lay out his case: his Michigan Occupational Safety and Health Administration file, which includes email exchanges, his annual reviews and other personnel records, witness statements, and the company’s defense, as well as a separate complaint he made to OSHA in February 2021 about safety violations at Sturgis. He never mentions cronobacter, but he describes conditions that could allow it to lurk there.

He claims that at Sturgis “meeting metrics frequently took precedence over product safety,” and that managers would intentionally misrepresent the severity of issues to their bosses at division headquarters. In 2019, Abbott recalled a batch of Calcilo XD formula because it was discolored and smelled rancid. Inside the plant, he says, workers knew the problem was that powder was getting stuck in the seams of cans and that several other batches—each comprising tens of thousands of cans—were also affected. To avoid finding more, supervisors told employees to check the seams of empty cans.

The factory is built around dryers, towers four to six stories tall that turn a liquid mix into powder. Before the formula reaches the dryer, it’s been blended, pasteurized, and homogenized, but not sterilized. Once it leaves the dryer, it’s sifted and packaged. It’s inside the dryers and afterward that formula is most likely to be contaminated. The whistleblower says that some of the processing equipment at Sturgis needed serious repair and had for several years. Pipes had pinholes that allowed bacteria to enter and, at times, led to bacteria not being adequately cleaned out. Formula flowing through these pipes could pick it up—and did.

He says that in 2019 management also decided it was no longer necessary to have an engineer review certain cleaning processes. Instead, a contract worker could look them over. He blames the worker’s inexperience for missing a brief electrical outage that caused cleaning equipment inside processing machinery to malfunction, which resulted in it being covered in caked-on moldy formula.

Routine testing revealed that several samples of that batch of finished formula were contaminated with microorganisms, he alleges. Managers decided not to destroy it all. Employees were told to discard only those cans produced within a certain time frame, he says, and the rest they distributed without additional testing. Sturgis had already destroyed $8 million worth of formula, he says, and the managers didn’t want to lose more.

The FDA didn’t mention the incident in its inspection report. According to the whistleblower, staff and department managers congratulated one another on making it through the audit without any warnings, and a supervisor admitted it had been awkward to avoid directly answering inspectors’ questions. The inspectors did learn that a sample of Alimentum had tested positive for cronobacter the month before. The batch hadn’t been released and would be destroyed. Abbott said it had found the source, sanitized the areas, retested them, and resumed production, and the FDA left it at that.

Ultimately it wasn’t these concerns that brought the whistleblower into conflict with management. On Friday, May 29, 2020, he sent an email to plant supervisors that began, “Hi—I believe X brought a stun gun/taser to work today. … We heard it go off twice. It sounded like someone was being electrocuted.”

A woman had indeed brought a Taser to work. She wasn’t sent home: Her husband merely came to the plant and picked up the weapon. The whistleblower assumed his colleague was protected by her friendship with the “Big Three,” women with seniority and authority. She was part of the in crowd. He wasn’t. On Monday he contacted Employee Relations at company headquarters. At Sturgis, some considered that a breach. “He went above management’s head and beyond our site to report the Taser incident, and they don’t want people to do that,” an employee said.

That summer he made two mistakes reviewing records for formula distributed internationally. He’d made another one earlier. He said it was because he hadn’t received sufficient training; others said they’d made similar errors. Managers at the facility said he’d put the company at risk of a recall and fired him in August.

He filed a claim of retaliation with Michigan’s Occupational Safety and Health Administration. Five months later, in February 2021, he filed a federal OSHA claim and provided pages of detailed allegations about product safety. In it, he alleged that at Sturgis “concealing information from the FDA was celebrated by management” and “performance errors, including egregious performance errors, were condoned as long as ‘numbers’ were met and one looked the other way.” OSHA almost immediately shared the complaint with the FDA and Abbott, which says it cooperated with the inquiry. The agency could have scheduled an inspection then instead of waiting until the annual one that September but didn’t. It says it’s reviewing its response.

In June 2021, Michigan dismissed his claim of retaliation; OSHA is still investigating. In October he sent his whistleblower complaint to the FDA, alleging that if employees could speak freely, Sturgis would be like a “house of cards.”

“You’re telling me my baby was on recalled formula that’s causing meningitis, but ours is just bad luck. I just wasn’t buying that”

When FDA inspectors saw reports of cronobacter contamination in Abbott’s records in September 2021, they followed protocol. The previous inspection, two years earlier, hadn’t turned up any egregious violations, so they didn’t swab the facility themselves—they relied on the company’s records of doing so.

In October the whistleblower’s complaint reached some at the FDA by email; copies sent by FedEx to the agency’s leaders are still lost in the mailroom. Those who did read it didn’t share it with them. “The standard procedure was not to escalate,” Califf, the agency’s commissioner, said later. But “when you get something this detailed and this extensive, it’s not routine,” says Stephen Ostroff, a former senior FDA official. “It should have been immediately clear that this went beyond holding a grudge against the company,” says Brian Ronholm, director of food policy for Consumer Reports. “It should have caught the attention of everyone at the FDA.” Representative DeLauro wasn’t surprised that it didn’t. “I don’t see that this agency really wants to be a regulatory agency,” she says. “They normally come down on the side of the industry vs. the individual.”

As it was, no one interviewed the whistleblower until late December, when three inspectors arranged a three-hour video call. Soon after, they contacted Abbott to schedule a visit for early January. Abbott says it requires employees to be vaccinated against Covid, tests them weekly (the company makes the rapid test BinaxNow), and has had a lower incidence of infection than the surrounding county. But when the inspectors called, the company asked them to wait because of an outbreak at the plant.

At the end of the month, the inspectors said they couldn’t wait any longer. They went to Sturgis, and they found cronobacter. Abbott would later explain that the bacteria was brought in by contract workers repairing the roof, who had access to areas they shouldn’t have. The inspectors again noted a history of pits and cracks in the dryer towers. They saw standing water in equipment that should have been dry. Abbott’s own records listed 310 problems with water in the past two years: leaks, moisture, and condensation blamed, in part, on a roof that needed to be repaired.

Despite urging from the FDA on Feb. 15 and again the next day, Abbott didn’t announce a recall. On the 17th, the FDA issued a consumer advisory, and Abbott announced a voluntary recall. Eleven days later, the company expanded it.

By then, Owen Bayer—5 months old, 15 pounds, born healthy, fed Similac Pro-Advance—was in a St. Louis hospital. He was distressed and vomiting, his eyes were glassy, and his temperature reached 104F. “He wasn’t really responding very well to anything,” his mother, Jordyn, says—not to the medicine, not to the light, not to his name. Doctors told them Owen was having a seizure. “He wasn’t shaking. He was stiff,” his father, Zach, says. “It was like his body was locked in.”

Owen would have to be brought to a bigger hospital. When the ambulance arrived, medics said he wasn’t stable enough for the 45-minute ride. He’d have to be airlifted instead. Jordyn and Zach watched as he was intubated, put on a stretcher, and placed in the helicopter. They couldn’t join him.

The doctors suspected a bacterial infection, likely meningitis, and started him on intravenous antibiotics. They performed a spinal tap to be sure. They managed to stop the seizures. Owen was sedated and wrapped tight and slept through the next day. By then, his parents had been told he did have meningitis—just bad luck, a doctor said. “That was a really awful way to describe it,” Jordyn says. “But I had some peace with that because it was like, OK, there was really nothing I could have done to prevent this. It just kind of happened.”

Jordyn had learned about the Abbott recall a day or two after it was announced but hadn’t heard anything about cronobacter. Now she started wondering. “This is too much of a coincidence,” she says. “You’re telling me my baby was on recalled formula that’s causing meningitis, but ours is just bad luck. I just wasn’t buying that.” The doctors hadn’t looked for cronobacter initially and told her that the antibiotics Owen had been given for the past three days would make it impossible to do so.

Once Owen was back home and recovering, Jordyn brought four cans of recalled formula to the Missouri Department of Health and Senior Services. One opened can of Similac Pro-Sensitive formula was contaminated with cronobacter. Because Owen himself hadn’t been tested for cronobacter, he isn’t part of the FDA’s official count.

On a mid-May afternoon, just up from his nap, Owen is bright and giggly and hungry. He eats some solid food now and liquid formula, too, made by Abbott. He’s sitting up, rolling from his belly to his back, starting to crawl. He has two teeth. Jordyn and Zach know that in some ways they are lucky, and they don’t know how long that will last. “He could have mental delays, physical delays, learning disabilities, things that we’re not going to know for a while,” she says. “We’re just supposed to be on the lookout. So, I’m always asking myself: ‘Is that normal?’ ”

Abbott’s commanding position in infant formula is, in part, the result of government intervention on behalf of families in need. The Special Supplemental Nutrition Program for Women, Infants, and Children, known as WIC, provides powdered formula—and only powdered formula except in unusual cases—to about half the babies born in the US each year. Every state enters a contract with a single manufacturer. Abbott now has deals with 35 states and the District of Columbia.

The companies offer the states significant rebates. Last year, Texas bought almost $210 million worth of Abbott’s standard powdered infant formulas for $10 million. But having those guaranteed sales means better shelf space at stores, which means the “private mommies,” as they’re called, often buy the same brand as WIC parents.

The Big Three

Every US state has a contract with one manufacturer to provide formula through the Special Supplemental Nutrition Program for Women, Infants, and Children, known as WIC. Abbott has 35 state contracts.

In May, as those in the WIC program still struggled to find formula, US Secretary of Agriculture Tom Vilsack wrote Abbott with “grave concern” that it hadn’t promised rebates for other brands for as long as the shortage lasted. Abbott has since said it will do so at least through October and will spend $5 million to help families who rely on EleCare, which is designed for infants with food allergies, with medical and living expenses.

In May the company also put out, on Twitter, a definitive statement about the FDA’s investigation: “The formula from this plant did not cause these infant illnesses.” That didn’t go over too well with some experts. “They can’t say that. They can’t rule out that their plant was the source,” says Craig Hedberg, a University of Minnesota epidemiologist. “I’m unimpressed with their argument,” says Ostroff, the former FDA official. Establishing a direct link isn’t ever likely to be possible, but, he says, “if it looks like a duck and quacks like a duck, it’s probably a duck.” Later, Abbott said it has tested more than 10,000 cans of formula and hasn’t found cronobacter in any.

On May 16 the consent decree was made public. Sturgis had to improve its safety procedures and product testing, repair its equipment, replace the roof, and redo the floors, all under the FDA’s watch, before it could start up again. “The consent decree is an admission that you could turn into an indictment fairly quickly,” says Bill Marler, a food safety lawyer. Attorneys alleging misdemeanor violations of the Federal Food, Drug, and Cosmetic Act would only have to prove Abbott’s liability, not its intent, he says: “If you’re producing food in insanitary conditions, you’re stuck.” Abbott says that the consent decree is a civil agreement and that it chose not to challenge the allegations in the document so it could restart production quickly.

Jane Hernandez is among those parents who have filed lawsuits against Abbott. The Bayers may soon join them. This summer, DeLauro introduced a bill to separate the food division from the FDA altogether in hopes that will help hold it to account. The FDA hasn’t commented on that but says that in addition to its internal review, it’s arranged for an external one. It’s reconsidering inspection protocols, especially about when to swab its own environmental samples. It also says there’s only so much it can do: “The FDA stresses the importance of a company’s quality systems and culture,” a spokesperson says. “Ultimately, when problems are found it is the responsibility of the firm to correct those issues to keep consumers safe.” An Abbott spokesperson says that “Sturgis employees are committed to quality and safety and are determined to re-earn the trust of parents, as is Abbott.”

On June 15, less than two weeks after the Sturgis factory reopened, a storm blew through town. The plant flooded, and production shut down. The company hasn’t said when Sturgis will resume making Similac, but since early July it’s been producing EleCare. As it’s being processed, 180 cans from every batch will be tested for cronobacter. If it’s detected, everything must stop, and within 24 hours the company must notify the FDA that the pathogen has returned. —With John Tozzi and Monte Reel

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