Abbott Laboratories has agreed to pay $384,999,040 — about $385 million — to resolve Justice Department False Claims Act allegations that powdered infant formula and nutritional products made at its Sturgis, Michigan, and Casa Grande, Arizona, plants from Jan. 1, 2018, through Dec. 31, 2022 failed to meet federal and state manufacturing requirements, the department announced Monday, Sept. 14, 2026.

Under the civil deal, Abbott will pay $348,700,868 to the United States 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 (WIC) pays for more than half of all infant formula purchased in the United States, the Justice Department said — meaning much of the disputed spending ran through a taxpayer-funded pipeline that dominates the domestic formula market.

The settlement resolves a qui tam lawsuit brought by former Abbott employees Scott Millard, Kristine Cooper, and Loren Cooper, who will receive a $69 million share of the federal recovery. The case is captioned United States, et al., ex rel. Scott Millard, et al., v. Abbott Laboratories, No. 1:22-cv-994 (W.D. Mich.). The Justice Department stressed that the claims resolved by the settlement “are allegations only and there has been no determination of liability.”

In its Nov. 13, 2025, Complaint in Intervention, the United States alleged Abbott caused government programs to buy Sturgis-made powder formula that did not meet statutory, regulatory, and contractual requirements — including conditions that put products at “unacceptable risk of microorganism contamination.” The complaint described persistent roof leaks managed with temporary “roof leak umbrellas,” cracked and pitted spray dryers kept in service, longer production runs between cleaning cycles, and alleged failures to disclose certain “micro” contamination test results to the FDA during 2019 and 2022 inspections.

“Today’s settlement is a victory for American families and makes clear the safety of our children is not negotiable,” Acting Deputy Attorney General Trent McCotter said in the Justice Department release. “Abbott will pay a substantial sum to resolve serious allegations it violated federal health and safety requirements designed to protect babies.”

“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,” Associate Attorney General Stanley E. Woodward, Jr. said.

Abbott, in a separate statement Monday, said it will pay a total of $385 million to resolve the Justice Department investigation and lawsuit, related relator suits, and claims by several state attorneys general tied to manufacturing and the 2022 powdered infant formula recall at Sturgis. The company said the settlement “does not represent any finding of fault or liability,” and that the government “has closed its criminal investigation regarding this matter.”

Abbott also reiterated that “no unopened, distributed Abbott infant formulas have ever tested positive for Cronobacter sakazakii,” that FDA testing of unopened product from the homes of infants under investigation in early March 2022 was negative, and that the CDC later concluded there was “no definitive link” between the Sturgis facility and the clinical cases investigated at that time.

“Nothing matters more than the safety and quality of Abbott’s products,” the company said. “We make infant formula with the same care we would for our own families and are deeply committed to earning and maintaining caregivers’ trust.”

The civil resolution was handled 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.

Sources