FDA Failed to Act on Critical Safety Information Before Infant Formula Recall
Inspection records of Abbott Nutrition’s manufacturing plant suggest that problems with the company’s now-recalled products, linked to at least two deaths, could’ve been uncovered sooner
By Ryan Felton
Infant formula made by Abbott Nutrition tested positive for a deadly bacteria at least twice dating back to 2019, according to newly released records, an issue the Food and Drug Administration cited last month when announcing a recall of products made by the company.
Abbott issued the sweeping recall over concerns of bacterial contamination in multiple products—including certain Similac, Alimentum, and EleCare brands—that are now linked to at least two infant deaths and multiple illnesses. The risk stems from a particularly rare and deadly bacteria, Cronobacter sakazakii.
But Abbott tells Consumer Reports that it shared those test results with the FDA during an inspection months earlier—in September 2021—just as the first report of death from the rare bacteria became known.
The revelations may reignite concerns among lawmakers and consumer advocates that the FDA could have acted sooner to remove infant formula from the market.
For weeks, lawmakers and advocates have questioned whether the FDA had a chance to catch the problem earlier. The agency first learned in September 2021 about a potential link between powdered infant formula made by Abbott and cronobacter, a rare and deadly infection, yet the recall wasn’t issued until four months later, after reports that at least two infants died and others were hospitalized after consuming the products. The FDA, along with the Centers for Disease Control and Prevention, says the reports of death and illnesses are being investigated.
The new records—released Tuesday in response to Freedom of Information Act requests by CR and other news organizations—include agency inspection reports in 2019, 2021, and 2022. The reports show that the FDA had documented serious and ongoing safety concerns at Abbott’s plant just as the outbreak emerged through this month.
But the FDA seemingly failed to make the company’s testing records a concern until additional reports of death and illness emerged.
An Abbott spokesperson says the company is taking the situation “very seriously and are working closely with the FDA to implement corrective actions.”
“We have already begun implementing corrective actions and enhancements at the facility,” the spokesperson says, “leveraging new technology and strengthening our processes, to give parents and customers renewed confidence in the quality of manufacturing at our Sturgis plant when we restart operations there.”
The spokesperson also says that no infant formula comes into direct contact with areas in the factory where Cronobacter was found, and that its testing did not detect that bacteria or salmonella in any of the products it distributed to consumers. In addition, they say, “Importantly, the unique genetic makeup of the Cronobacter sakazakii microbes found in nonproduct areas at the Sturgis facility did not match the Cronobacter sakazakii microbes from the reported cases.”
James E. Rogers, PhD, director of food safety and research at CR, points out that cronobacter may still have been present in other untested samples of product distributed to consumers. And he says that Abbott’s statement on the genetic makeup of cronobacter strains found at the company’s facility and in sick infants is puzzling.
“I am not sure why Abbott would emphasize this fact because plants can contain multiple strains of a pathogen,” he says. “Just because the patient strains and those isolated so far don’t match does not mean that the patients were not, or could not be, sickened by cronobacter from infant formula.”
Unanswered Questions
When the FDA announced the recall, the agency said that multiple samples taken at Abbott’s lab last month revealed cronobacter in several locations, and it said the company’s own records showed that infant formula was previously destroyed because of bacterial contamination.
But questions have swirled about what the FDA knew as the first reports of bacterial infections emerged.
The FDA had sent an inspector to Abbott’s plant in September 2021, the same week it first learned about an infant in Minnesota who was hospitalized with cronobacter after consuming formula made by the company, CR reported last month. The report of that inspection, released Tuesday, documented serious sanitation concerns.
For example, the report cites an employee who failed to wash his hands and change his gloves after touching nonfood contact surfaces.
“In addition,” the report says, “the Operator’s exposed wrists, between the glove and smock cuff, were observed entering the inside of the potassium chloride ingredient bag when scooping ingredients.”
Yet that inspection report does not mention Abbott’s test records showing that formula was previously destroyed in 2019 and 2020 after tests revealed it was contaminated with cronobacter. Those tests weren’t documented by the FDA until the agency conducted a follow-up inspection last month.
The Abbott spokesperson says the company provided the FDA the test results at the inspection in September 2021.
“Our quality system and testing are set up to detect the presence of microbes prior to distribution,” the spokesperson says. “As a result of that system, once in 2019 and once in 2020, our regular testing found the presence of Cronobacter sakazakii in finished product. This product was never distributed to consumers.”
CR has repeatedly asked the FDA over several weeks about why it sent an inspector to Abbott’s facility in September 2021, and whether that inspector knew of the cronobacter report. (Infant formula makers are typically inspected by the agency once per year.) Beyond what was uncovered at that inspection, the FDA already had documented reasons of concern, suggesting that it could have acted more urgently: An earlier inspection by the agency had also cited the company for failing to test a representative sample of formula for salmonella. The FDA also has authority to mandate a recall of infant formula if problems are found.
On Wednesday, an FDA spokesperson told CR that the September 2021 visit was “a regularly scheduled surveillance inspection” but declined to explain whether that inspector was made aware of the cronobacter report.
“This remains an open investigation with many moving parts,” the spokesperson said. “Accordingly, the agency is not in a position to comment further.”
The more recent inspection, completed this month, offers other examples of contamination concerns in Abbott’s own records that seemingly could’ve been detected at the earlier inspection, including that Abbott identified cronobacter in production areas on at least eight occasions between September 2019 and February 2022.
Sanitation issues persisted after the September 2021 inspection, as well, the records show. In the most recent inspection, the FDA cited Abbott again for personnel failing to wear protective gear while handling ingredients. The FDA also said that Abbott failed to adequately investigate complaints of bacterial illness.
Brian Ronholm, director of food policy at CR, says the reports of conditions at Abbott’s plant are alarming.
“The FDA knew back in 2019 that microbiological testing going on at Abbott’s plant was insufficient and later found that there was surface contamination from a dangerous bacteria at the facility,” says Brian Ronholm, director of food policy at CRs. “It seems evident that the agency should have acted sooner. There will be plenty for the FDA to review about their enforcement process when this investigation concludes.”
What to Know
To see whether a product is part of the recall, check the lot codes on the bottom of the container for these 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 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 any recalled Abbott products, the FDA recommends not using 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.
More from Consumer Reports:
Top pick tires for 2016
Best used cars for $25,000 and less
7 best mattresses for couples
Consumer Reports is an independent, nonprofit organization that works side by side with consumers to create a fairer, safer, and healthier world. CR does not endorse products or services, and does not accept advertising. Copyright © 2022, Consumer Reports, Inc.
