Abbott to pay $385 million over infant formula safety allegations, DOJ says

Abbott Laboratories has agreed to pay $384,999,040 to resolve allegations that it caused false claims to be submitted to federal and state programs between Jan. 1, 2018, and Dec. 31, 2022, the Justice Department announced. The allegations involved certain powder infant formula and nutritional therapy products manufactured at Abbott facilities in Sturgis, Michigan, and Casa Grande, Arizona. Abbott is an Illinois-based health care company.

According to the department, the settlement follows a Nov. 13, 2025, 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 government alleged that Abbott knowingly manufactured the formula in conditions that placed it at an unacceptable risk of microorganism contamination and significantly affected its reliability, quality and safety.

Acting Deputy Attorney General Trent McCotter said the settlement makes clear that “the safety of our children is not negotiable.” Associate Attorney General Stanley E. Woodward Jr. said the department would hold accountable companies that knowingly misrepresent compliance with health and safety standards. U.S. Attorney Timothy VerHey for the Western District of Michigan and USDA Inspector General John Walk also commented on the settlement.

The complaint alleged that recurring roof leaks at the Sturgis plant caused water to run and drip over equipment and that Abbott used temporary measures, including leak umbrellas, instead of permanently addressing the underlying problems, even though company leadership understood the contamination risks. The government also alleged that Abbott continued operating spray dryers despite documented cracks and pits and lengthened the number of production batches processed between cleaning cycles, enabling the company to increase production. The complaint further alleged that Abbott intentionally avoided testing for bacterial growth to prevent positive contamination results and, in certain instances, failed to disclose contamination findings when responding to FDA requests during inspections in 2019 and 2022.

Under the agreement, Abbott will pay $348,700,868 to the United States to resolve the False Claims Act allegations and $36,298,172 to certain states for claims settled through their Medicaid and WIC programs. The USDA-funded Special Supplemental Nutrition Program for Women, Infants, and Children, or WIC, pays for more than half of all infant formula purchased in the United States, according to the release.

The case was brought under the False Claims Act’s qui tam provisions, which allow private individuals to sue on behalf of the federal government and share in any recovery. Three former Abbott employees who filed the suit — Scott Millard, Kristine Cooper and Loren Cooper — will receive $69 million as their share of the federal settlement. The case was filed in the U.S. District Court for the Western District of Michigan.

The Justice Department noted that the claims resolved by the settlement are allegations only and that there has been no determination of liability.