Abbott Agrees to Pay Over $384M to Settle FCA Allegations Involving Potentially Contaminated Infant Formula

Posted September 23, 2026

By the Constantine LLP Whistleblower Team

On September 14, the DOJ announced that Illinois-based healthcare company Abbott Laboratories (Abbott) agreed to pay more than $384 million to resolve allegations that it caused the submission of false claims involving potentially contaminated products to federal and state programs from Jan. 1, 2018 through Dec. 31, 2022. The DOJ alleged that Abbott failed to comply with applicable manufacturing and safety requirements for certain powdered infant formula and nutritional therapy products at its Sturgis, Michigan, and Casa Grande, Arizona facilities. [1]

Three former Abbott employees brought the case under the qui tam provisions of the False Claims Act. They will receive $69 million as a reward.

What Was Alleged in the Complaint?

In 2025, the government filed its complaint in intervention alleging that Abbott manufactured infant formula at its Sturgis facility under conditions that posed a risk of microorganism contamination and compromised the products’ quality, reliability, and safety.[2]

According to the complaint, roof leaks frequently allowed water to drip onto and run over equipment at the Sturgis facility. Abbott implemented temporary solutions including roof leak umbrellas in attempts to divert water in product processing areas. The government alleged that Abbott’s leadership knew the moist environment increased the risk of microorganism contamination but failed to address the underlying problems.

The government also alleged that Abbott ran spray dryers, which convert liquid formula into a dry powder, even after Abbott documented cracks and pits in the equipment. These defects further increased the risk of microorganism contamination, particularly when moisture was present.

Abbott allegedly worsened conditions in its spray dryers by increasing the number of product batches processed between cleaning cycles, allowing it to boost production. Abbott also allegedly avoided testing for bacterial growth to prevent positive contamination results. In certain instances, testing revealed microorganism contamination, but Abbott allegedly failed to disclose those results to the FDA during its 2019 and 2022 inspections of the Sturgis facility.[3]

Comments on the Case

Associate Attorney General Stanley E. Woodward, Jr. commented: “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. The Department will hold accountable bad actors that knowingly misrepresent compliance with essential health and safety standards designed to protect American families.”[4]

According to Constantine LLP partner Marlene Koury: “The False Claims Act reaches beyond traditional billing fraud. Companies may also face FCA liability when they knowingly cause the government to pay for products that fail to meet material manufacturing requirements. This settlement reinforces the government’s commitment to holding companies accountable for the safety and quality of products that families rely on.”

What Does the Settlement Cover?

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 oversees the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) program, which provides eligible participants with nutritional assistance, including infant formula. Over half of all infant formula bought in the United States is funded through WIC. State Medicaid programs also cover certain infant formula.

Were Whistleblowers Involved in this Case?

The settlement resolves a case brought under the qui tam provisions of the False Claims Act, allowing private parties to file lawsuits on behalf of the government against those who defraud the government and receive a portion of any monetary recovery as a reward. The whistleblowers (or relators) in this case were Abbott employees: Scott Millard, Kristine Cooper, and Loren Cooper. They will receive $69 million.

Our Firm Represents False Claims Act Whistleblowers

Constantine LLP has extensive experience representing whistleblowers under the False Claims Act. If you would like to learn more about our firm’s False Claims Act successes, what it means to be a whistleblower, or believe you have a case, please contact us and we will connect you with a member of the Constantine LLP whistleblower team for a free and confidential consultation.