Abbott Laboratories (Abbott), an Illinois-based healthcare company that manufactures and sells infant formula and nutritional therapy products, has agreed to pay $384,999,040 to resolve allegations that it caused false claims to be submitted between Jan. 1, 2018, and Dec. 31, 2022, to federal and state programs arising from its failure to manufacture certain powder infant formula and nutritional therapy products at its Sturgis, Michigan, and Casa Grande, Arizona, facilities in compliance with federal and state statutory, regulatory, and contractual requirements.
On Nov. 13, 2025, the United States filed its Complaint in Intervention alleging that Abbott caused government programs to purchase powder infant formula manufactured at the Sturgis facility despite the products’ failure to meet statutory, regulatory, and contractual requirements. The Complaint alleged that Abbott knowingly manufactured infant formula purchased with taxpayer dollars in an environment that put the products at unacceptable risk of microorganism contamination and significantly impacted the products’ reliability, quality, and safety.
“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.”
“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,” said Associate Attorney General Stanley E. Woodward, Jr. “The Department will hold accountable bad actors that knowingly misrepresent compliance with essential health and safety standards designed to protect American families.”
“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. “This settlement demonstrates our commitment to holding manufacturers accountable when the United States pays for noncompliant products.”
“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,” said USDA Inspector General John Walk. “This behavior is inexcusable and will not be condoned.”
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.
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.
Under the civil settlement agreement, Abbott will pay $348,700,868 to the United States to resolve the False Claims Act allegations and an additional $36,298,172 to certain States for claims settled by their State Medicaid and WIC programs.
The U.S. Department of Agriculture funds and regulates the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) program, which provides nutritional support – including infant formula – to eligible participants. More than half of all infant formula purchased in the United States is paid for with USDA funds through WIC. State Medicaid Programs also cover and pay for certain infant formula.
The civil settlement resolves claims brought under the False Claims Act’s qui tam provisions, which allow private individuals to bring suit on behalf of the United States for false claims submitted to federal programs and to share in any recovery. Relators Scott Millard, Kristine Cooper, and Loren Cooper, who were Abbott employees, will receive $69 million as their share of the federal settlement. The qui tam action, filed in the United States District Court for the Western District of Michigan, is captioned United States, et al., ex rel. Scott Millard, et al., v. Abbott Laboratories, No. 1:22-cv-994 (W.D. Mich.).
The resolution was the product of a coordinated effort by the Justice Department’s Civil Division, Commercial Litigation Branch, Civil Fraud Section, and the U.S. Attorney’s Office for the Western District of Michigan, with assistance from USDA’s Office of Inspector General.
This year, the Trump Administration launched the Task Force to Eliminate Fraud and the National Fraud Enforcement Division to enhance the Administration’s war on fraud, waste, and abuse in federal programs. When unscrupulous actors exploit these programs for their own financial gain, they defraud the government, harm the people these programs are designed to aid and protect, and undermine American businesses that play by the rules. The Civil Division’s False Claims Act enforcement plays a critical role in combatting such fraudulent schemes, recovering billions of dollars for the American taxpayers, and holding wrongdoers accountable. False Claims Act matters will continue to be on the forefront of the battle against fraud, and the Civil Division’s False Claims work will support and advance the mission of the Task Force to Eliminate Fraud and the National Fraud Enforcement Division.
The matter was handled by Civil Fraud Section Trial Attorneys Asha Natarajan and Erin Colleran of the Justice Department’s Civil Division and Assistant U.S. Attorneys Whitney Schnurr and Jacob Carlton for the Western District of Michigan.
The claims resolved by the settlement are allegations only and there has been no determination of liability.