How the FDA Bungled the Powdered Infant Formula Recall
A plant where Abbott Nutrition produced Similac, Alimentum, and EleCare had a history of violations. So why did it take so long to pull products off the market?
Update: On Monday, Feb. 28, Abbott had expanded its recall of infant formula to include an additional Similac product in response to a new report of bacterial illness associated with infant formula produced at the company’s facility. The bacteria, cronobacter, may have been a contributing cause of death, says the Food and Drug Administration, which is investigating.
Original: Last September the Food and Drug Administration learned that a Minnesota infant had been hospitalized for three weeks with a rare and deadly foodborne pathogen called Cronobacter sakazakii. The child, officials discovered, had consumed powdered infant formula manufactured by the company Abbott Nutrition.
The same week the FDA learned about the case, the agency dispatched an inspector to Abbott’s plant in the small town of Sturgis, Mich., where the formula was made. The inspector uncovered numerous violations of regulations intended to prevent contamination with the bacteria, records show. Perhaps the agency shouldn’t have been surprised: It had seen a similar issue at the plant just two years earlier.
Knowing the risk to infants—I mean, a 50 percent mortality rate—this is serious.
For one thing, it’s unclear why the FDA’s September inspection didn’t cite Abbott’s records of having destroyed products because of cronobacter contamination, which the company told CR took place in June 2020.
Manufacturers of infant formula are required to make testing records available to the FDA on request, and the agency can initiate a mandatory recall if it finds that an infant formula presents a health risk.
An FDA spokesperson said she had no comment at this time about the lapse or whether the September inspection was sparked by the cronobacter report, citing the ongoing investigation.
But the agency’s findings during the inspection last fall alone should have been enough for the FDA and Abbott to warn consumers about potential contamination, experts say.
“This bacterium is known to be extremely deadly to babies,” says Mitzi D. Baum, chief executive officer of Stop Foodborne Illness, a nonprofit group. “It is distressing that the facility was cited in September 2021 for unsanitary conditions, about the time when the first illness was reported.”
Bill Marler, a lawyer in Seattle who specializes in food-poisoning cases, agrees. “Knowing the risk to infants—I mean, a 50 percent mortality rate—this is serious,” he says.
In addition to the three illnesses and one death reported earlier, other reports of harm continue to come in. On Thursday, the West Virginia Department of Health & Human Resources linked a fifth case to the formula, an infant who developed a salmonella infection after ingesting the recalled product.
Other cases may emerge overseas. The potentially contaminated infant formula was distributed around the world, the FDA says.
“Because this involves the global distribution of a contaminated product consumed by an extremely vulnerable population,” says Brian Ronholm, director of food policy at CR, “you would expect the FDA to act urgently to leverage every regulatory tool they possess to prevent additional illnesses and deaths.”
Ellen Wichman, a spokesperson for Abbott, says the company conducts “extensive quality checks” on every batch of infant formula. That includes testing products for cronobacter and salmonella, she says, “and they must test negative before any product is released.”
The FDA notified Abbott about the four complaints, Wichman says, and in each case, tests of related product samples were negative for cronobacter and salmonella. The complaints were received from Sept. 20, 2021, to Jan. 11, 2022, according to the FDA.
In mid-February, testing found cronobacter in “non-product contact areas” in the facility, Wichman adds, and Abbott “took immediate corrective action, including a voluntary product recall on February 17.” The tests didn’t detect salmonella, the company says, and neither pathogen was detected in products that were shipped.
“We value the trust parents place in us for high-quality and safe infant nutrition, and we’ll do whatever it takes to keep that trust and resolve this situation,” Wichman says.
An FDA spokesperson said the agency was continuing to investigate, “and will provide additional consumer safety information when it becomes available.”
But Ronholm says the FDA’s statements ring hollow, especially because there’s no record of the agency sending an inspector back to the plant until late January.
“Once the severity of the situation became known, the FDA should have essentially set up shop at the facility and worked to resolve the problems,” he says.
Infant formula manufacturers must abide by specific FDA regulations, which exist in part to “prevent the manufacture of adulterated infant formula,” the agency says.
They’re also supposed to be held to more stringent oversight. The FDA inspects infant formula makers annually, more frequently than for other food manufacturers.
In addition, companies must test for contamination, looking specifically for cronobacter and salmonella, the same bacteria found in Abbott’s products. That’s because both pathogens have “a documented association with powdered infant formula,” the FDA says.
But two years before the FDA’s September 2021 visit, an agency inspector found Abbott’s Michigan facility had failed to test a representative sample for salmonella at the final stage of the production cycle.
When asked about the 2019 inspection, Wichman, Abbott’s spokesperson, said, “We took immediate corrective action and are continuing to follow all safety and quality protocols.”
Subsequent visits also found problems. For example, during its 2021 inspection, the FDA observed other violations of the infant formula manufacturing regulations at Abbott’s facility. Specifically, the agency found that company personnel failed to wash their hands before working with raw materials and infant formula.
Agency records documented a pattern of problems. “You did not maintain a building used in the manufacture, processing, packing, or holding of infant formula in a clean and sanitary condition,” the FDA wrote in a summary of the inspection findings posted online.
Copies of the full inspection reports were not immediately available.
Once the severity of the situation became known, the FDA should have essentially set up shop at the facility and worked to resolve the problems.
Destroyed Infant Formula
The inspection last fall ended Sept. 24, records show, the same week the FDA learned of the first cronobacter case in Minnesota.
Under FDA regulations, Abbott must maintain production and testing records of each batch of infant formula, along with any consumer complaints it receives. The company must also provide those records to the FDA when asked.
That includes tests conducted to detect cronobacter or salmonella. When the recall was issued last week, the FDA said that a review of Abbott’s internal records indicated “environmental contamination with Cronobacter sakazakii and the firm’s destruction of product due to the presence of cronobacter.”
Wichman says the incident in question happened in June 2020 and was identified through testing “that is required before product is released.”
“Product was destroyed per our quality process and FDA regulations, and no product was distributed to the market,” she says.
Yet the FDA doesn’t cite those records as part of its September 2021 inspection, despite observing multiple violations of sanitary standards and agency staff knowing of an initial cronobacter case possibly linked to Abbott’s infant formula. It’s unclear whether the agency saw those records, and the FDA spokesperson declined to comment, citing the ongoing investigation.
It wasn’t until after the FDA received the three additional reports of illness—two for cronobacter and one for salmonella—and launched a follow-up inspection late in January that it acknowledged Abbott’s records of prior contamination with cronobacter.
Marler, the food-safety attorney, says infant formula contamination cases are easier to investigate than other foods because the potential sources are limited. Infants typically only consume either breast milk or formula.
One adverse event is usually not enough to determine whether a foodborne illness is linked to a more widespread issue, says Doug Schultz, a spokesperson for the Minnesota health department, which alerted the FDA to the hospitalized infant last September.
But given how rare cronobacter infections are and its known association with infant formula, Marler says the first case in Minnesota should have been enough for the FDA to dig deeper sooner.
“You got one case, you should just be on it like white on rice,” he says. “I find this whole thing a bit troubling.”
More Cases Likely
Florida resident Luis Suarez is among those who say their child got sick after consuming the now-recalled formula.
In late January, Suarez purchased one of the affected products—Alimentum—for his daughter at a local CVS, according to a lawsuit he filed last week against Abbott. One of the containers included a lot number that matched the recall advisory, his complaint says.
The complaint alleges that just over a week later, Suarez’s daughter became ill after consuming the Alimentum, including “overwhelming diarrhea (in excess of 10 times a day), abdominal pain, severe diaper rash,” and more. Rafael de la Grana, an attorney representing Suarez in the case, told CR that the baby tested positive for salmonella. He also said Suarez couldn’t be made available for an interview, citing the pending litigation.
This is such a vulnerable class of individuals; it is children, babies, infants who are being affected by this.
“This is such a vulnerable class of individuals; it is children, babies, infants who are being affected by this,” he says.
When asked about the lawsuit, Abbott’s Wichman reinforced that “no distributed product from our Sturgis, Mich., facility has tested positive for the presence of either Cronobacter sakazakii or salmonella.”
What to Do
To see whether a product is part of the recall, check the lot codes on the bottom of the container for the following three markings:
- 22 through 37 as the first two digits in the code
- K8, SH, or Z2 as part of the code
- An expiration date of 4-1-2022 (APR 2022) or later
In addition, Abbott has recalled a Similac PM 60/40 powdered infant formula with the lot code 27032K800. This is a specialty formula for certain infants who would benefit from lowered mineral intake.
A full list of the recalled products hasn’t been made available to the public. Instead, the company said consumers can use a lookup tool on its website to find out whether a product they have is part of the recall. If it is, they can call Abbott Nutrition at 800-986-8540 for information on how to obtain a refund.
If you have recalled Abbott products, the FDA recommends not to use them. It says the recall doesn’t include liquid formula products or metabolic deficiency nutrition formulas, and advises that consumers should continue to use products not covered in the recall.
Cronobacter bacteria can cause severe, life-threatening infections such as sepsis, or meningitis, an inflammation of the membranes that protect the brain and spine. Symptoms include poor feeding, irritability, temperature changes, and jaundice. Infection may also cause bowel damage and could spread through the blood to other parts of the body.
The FDA says that if your child is experiencing those symptoms, immediately notify your child’s doctor and seek medical care. And the agency encourages healthcare providers and health departments to report confirmed cases to the Centers for Disease Control and Prevention.
Note that if you purchased affected infant formula with SNAP benefits, you now may be able to exchange it for products not typically covered by the program. Check your retailer for details.