STURGIS, MICHIGAN — Abbott will pay $348,700,868 to the United States to resolve False Claims Act allegations. Abbott will pay an additional $36,298,172 to certain states for claims settled by their State Medicaid and WIC programs.

The allegations arose from Abbott's 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. Roof leaks were a common occurrence in the Sturgis plant, leading to water running and dripping over equipment.

Abbott lengthened the number of product batches that passed through the dryers between cleaning cycles to increase production. The complaint alleged Abbott used temporary solutions like roof leak umbrellas despite knowing the wet environment increased contamination risk. Abbott allegedly continued running spray dryers with documented cracks and pits, increasing the risk of microorganism contamination.

The complaint alleges Abbott intentionally did not test for bacterial growth to avoid obtaining positive test results showing contamination. Relators Scott Millard, Kristine Cooper, and Loren Cooper will receive $69 million as their share of the federal settlement.

Acting Deputy Attorney General Trent McCotter said the settlement is a victory for American families and makes clear the safety of children is not negotiable. He said "Abbott will pay a substantial sum to resolve serious allegations it violated federal health and safety requirements designed to protect babies."

McCotter added that 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. said no company should be gambling on the health and safety of the nation’s infants by allowing unsanitary conditions to persist at a facility manufacturing baby formula.

Woodward said the Department will hold accountable bad actors that knowingly misrepresent compliance with essential health and safety standards designed to protect American families. U.S. Attorney for the Western District of Michigan Timothy VerHey said 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.

Why It Matters

The settlement addresses violations of health and safety standards designed to protect infants who consume formula purchased through government programs. 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." The resolution ensures accountability for entities that fail to meet the statutory and contractual obligations required for participation in federal and state nutrition programs.

Timeline

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. Abbott Laboratories agreed to pay $384,999,040 to resolve allegations it caused false claims for contaminated infant formula submitted to federal and state programs between Jan. 1, 2018, and Dec. 31, 2022.

McCotter said Abbott will pay a substantial sum to resolve serious allegations it violated federal health and safety requirements designed to protect babies. VerHey said 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. The settlement demonstrates a commitment to holding manufacturers accountable when the United States pays for noncompliant products.

What's New

In 2022, Abbott Laboratories faced a recall of its powdered infant formula due to contamination concerns, which led to investigations and lawsuits. The recall was related to the Sturgis, Michigan facility, and the FDA confirmed that no unopened, distributed Abbott infant formulas tested positive for Cronobacter sakazakii. A research publication titled Abbott Laboratories Fined for Medical Device Kickback Scheme was published in Biomedical Safety & Standards.