Abbott To Pay $385 Million Over Unsafe Baby Formula Plant Conditions
Abbott Laboratories will pay nearly $385 million to resolve federal and state allegations that it sold infant formula manufactured in substandard, contaminated facilities to government programs between 2018 and 2022.
The settlement resolves a civil lawsuit alleging that the Illinois-based healthcare company knowingly submitted false claims to federal and state healthcare and nutrition programs. Government officials said the company produced powdered infant formula and nutritional therapy products at facilities in Sturgis, Michigan, and Casa Grande, Arizona, that failed to meet basic safety and legal requirements.
Under the agreement, Abbott will pay $348,700,868 to the federal government and $36,298,172 to state Medicaid and Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) programs. The USDA funds the WIC program, which covers more than half of all infant formula purchased nationwide.
Federal prosecutors alleged that Abbott operated its Sturgis plant under conditions that created serious contamination risks. According to the complaint, recurring roof leaks sent water dripping directly over processing equipment. Instead of fixing the roofs permanently, the company installed temporary capture devices, known as roof leak umbrellas, despite internal recognition that standing moisture invited bacterial growth.
The complaint further detailed that Abbott continued running cracked spray dryers, ran extra batches between scheduled cleanings to boost output, skipped bacterial tests to avoid positive contamination findings, and withheld contamination records from Food and Drug Administration inspectors during 2019 and 2022 reviews.
“Today’s settlement is a victory for American families and makes clear the safety of our children is not negotiable,” said Acting Deputy Attorney General Trent McCotter. “Abbott will pay a substantial sum to resolve serious allegations it violated federal health and safety requirements designed to protect babies. The Justice Department will act decisively against anyone who puts American families at risk and ensure misconduct carries serious consequences.”
Associate Attorney General Stanley E. Woodward, Jr. stated that “no company should be gambling on the health and safety of our Nation’s infants by allowing unsanitary conditions to persist at a facility manufacturing baby formula.”
“It is critical that infant formula manufacturers adhere to regulatory and contractual requirements to ensure that the products they manufacture are safe for the babies who consume them,” said U.S. Attorney Timothy VerHey for the Western District of Michigan.
USDA Inspector General John Walk called the plant conditions unacceptable, adding, “Parents rely on companies like Abbott Laboratories to responsibly follow the rules and ensure their products – especially baby formula – are safe. USDA OIG remains vigilant against those that would compromise public health and safety by failing to comply with legal standards and put infants at risk. This behavior is inexcusable and will not be condoned.”
The case originated as a whistleblower lawsuit filed under the False Claims Act by three former Abbott employees: Scott Millard, Kristine Cooper, and Loren Cooper. Under the act’s provisions, the three whistleblowers will collectively receive $69 million from the federal recovery. The settlement was handled by the Justice Department’s Civil Division, the U.S. Attorney’s Office for the Western District of Michigan, and the USDA Office of Inspector General.
Grok Assessment
Abbott is paying nearly $385 million to settle False Claims Act allegations that it sold powdered infant formula made under unsafe conditions at Sturgis, Michigan, and Casa Grande, Arizona, to federal and state programs (including WIC and Medicaid) from 2018–2022. There is no admission of liability, and the Trump-era Justice Department closed a related criminal investigation. - DOJ
The DOJ complaint alleged recurring roof leaks handled with temporary “umbrellas” instead of permanent repairs, cracked spray dryers, extra production runs between cleanings, skipped bacterial testing, and withheld contamination records from FDA inspectors in 2019 and 2022. Three former employees who filed the whistleblower suit will split $69 million of the federal recovery. About $349 million goes to the federal government and $36 million to states. - TFP (article above)
Abbott’s position is consistent with what it has said since the 2022 recall: government tests of unopened product from the homes of the infants under investigation were negative for Cronobacter sakazakii; no unopened, distributed Abbott formula has ever tested positive; and the CDC later said there was no definitive genetic link between the plant and the clinical cases. The 2022 Sturgis shutdown (the country’s largest formula plant) still triggered a severe national shortage. - AP (left wing)
Conservative coverage of the original 2022 crisis (NY Post, Fox) focused less on a simple “corporate greed” story and more on FDA slowness, ignored earlier whistleblower warnings, mailroom delays, and the Biden administration’s delayed import and production response after closing a critical plant. That frame still matters: the settlement extracts a large civil payment years later while leaving the underlying concentration of the U.S. formula market and regulatory lag largely unaddressed. A civil payout without a finding of fault or a criminal case is the typical end-state for this kind of FCA matter. - NY Post, 2022 (right wing)
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More from the DOJ Press Release
As described in the complaint, roof leaks were a common occurrence in the Sturgis plant, leading to water running and dripping over equipment. Rather than permanently addressing the root causes, Abbott used temporary solutions, such as roof leak umbrellas, to try to divert leaks in product processing areas even though Abbott corporate leadership understood that the wet environment put the products at increased risk of microorganism contamination.
Similarly, the complaint alleged that Abbott continued to run spray dryers, where liquid formula was transformed into a dry powder, even after Abbott documented cracks and pits in the dryers, which also increased the risk of “micro” contamination, particularly in the presence of moisture.
Roof leak umbrellas, Grok summary:
Roof leak umbrellas are temporary industrial leak-diverters — not rain umbrellas. They are hanging catchers (often vinyl/tarp “umbrella” or funnel shapes) installed under a leaking roof so water is collected and piped away instead of dripping onto floors or equipment. Commercial versions look like a square or cone tarp with a drain hose. - See example here
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Further, the Department alleged that Abbott made its spray dryer conditions worse by lengthening the number of product batches that passed through the dryers between cleaning cycles — enabling Abbott to increase production.
The complaint also alleges that Abbott intentionally did not test for bacterial growth to avoid obtaining positive test results showing contamination, and that in certain instances where testing demonstrated “micro” contamination, Abbott failed to disclose the test results when responding to requests from FDA during 2019 and 2022 inspections at the Sturgis facility.
Batch limit, Grok summary:
There is no public, official number in the DOJ press release or the widely reported complaint summary for how many batches Abbott was supposed to run before a spray-dryer cleaning cycle. The government only said Abbott lengthened the number of batches between cleanings beyond what was safe, to raise output. It did not publish the old limit, the new limit, or a recommended industry cap.
What exists instead is industry practice, not a single FDA “batch limit”:
- Spray-dryer cleaning is usually scheduled by campaign length (days or weeks of continuous running), product changeovers, and equipment condition—not a fixed universal batch count.
- For nutritional / infant-formula–type products (sticky, fat-filled, campaigned formulas), equipment vendors and hygienic-design guidance commonly describe about 4–12 weeks between full wet CIP cycles when the dryer and CIP system are working well. Commodity powders can run longer; specialty or high-risk products shorter.
- Wet CIP introduces water into a dry-process environment. After CIP, the dryer must be fully dried. FDA’s 2022 Sturgis findings included that Abbott had not validated the “dry-out” step after water was introduced during cleaning, and that dryers had a documented history of cracks and pits. Those defects matter more as more batches pass through between cleanings.
So the allegation is not “they ran X batches instead of Y.” It is that they extended campaigns past their own safe interval while running damaged dryers, which raises contamination risk if moisture or product residue sits in cracks. The exact batch counts remain in the sealed or lightly excerpted complaint, not in the public settlement announcement.
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Micro contamination, Grok summary:
In this case, “micro” contamination is DOJ shorthand for microbiological (microbial) contamination—presence of bacteria or other microbes in the product or in the plant environment. It is not a separate scientific category from ordinary microbial contamination.
Scientific meaning (baby formula)
Powdered infant formula is not sterile. The microbes of concern are those that can survive drying and sicken infants, mainly:
- Cronobacter spp. (especially C. sakazakii): environmental Gram-negative bacteria that persist in dry powder and wet niches (leaks, cracks, standing water). In infants they can cause sepsis and meningitis.
- Salmonella spp.: the other pathogen FDA requires finished-product testing for.
FDA treats a production lot as failing if those organisms are detected at all in a specified sampling plan: 30 × 10 g samples for Cronobacter (M = 0, none detected) and 60 × 25 g for Salmonella (M = 0). Detection at that plan’s limit of detection is enough; there is no “safe” allowed count.
Scientifically, contamination can be:
- Finished-product contamination — organism in the powder itself.
- Environmental contamination — organism on floors, dryers, drains, or other plant surfaces. That does not automatically mean every can is contaminated, but it shows conditions that can support pathogens and recontaminate powder after drying.
Moisture (roof leaks, CIP water that is not fully dried out, pits in spray dryers) is the scientific link: Cronobacter needs water to grow even if the finished powder looks dry.
Legal meaning (this product)
Under U.S. law, infant formula is adulterated if:
- It contains Cronobacter or Salmonella above the “none detected” standard in 21 CFR 106.55(e); or
- It was processed under conditions that do not meet infant-formula CGMP / process-control rules (FD&C Act §§ 402(a)(1), 402(a)(4), 412(a)(3); 21 CFR Part 106), even if a particular can never tested positive.
In the Abbott settlement, DOJ used “micro” contamination in that second, broader sense: risk that formula sold to WIC/Medicaid was manufactured in an environment with unacceptable microorganism risk (leaks, cracked dryers, skipped tests, withheld positives). The civil False Claims Act theory is that Abbott certified the product met safety and contract specs when, the government says, those process conditions were not met. That is allegations only; the settlement is not a finding that distributed, unopened formula contained Cronobacter.
Abbott’s counterpoint stays on the narrower scientific test: no unopened, distributed Abbott formula has tested positive for C. sakazakii, and CDC later said there was no definitive genetic link between the plant strains and the 2022 clinical cases.
Short version: scientifically, “micro” here means pathogenic or indicator microbes (chiefly Cronobacter/Salmonella) in powder or the plant. Legally, for this product it means either a failed pathogen test or manufacture under conditions that make the formula adulterated and noncompliant with government-program specs—without requiring proof that a given can made an infant sick.
More articles on topic
Parents whose 13-day-old daughter died after having tainted Similac formula can sue Abbott Nutrition: judge - NY Post, 2024
Abbott baby formula plant at center of nationwide shortages reopens — again - NY Post, 2022
Abbott Nutrition informed about problems with baby formula plant months before previously known: Reports - Fox News, 2022
Baby formula shortage: Government watchdog announces FDA audit - Fox News, 2022
Congress grills Abbott executive over failures in infant formula plant shutdown - Washington Examiner, 2022