Abbott Agrees to Pay Nearly $385 Million Over Infant Formula Manufacturing Allegations

September 22, 2026

Abbott infant formula settlement — Abbott Laboratories has agreed to pay nearly $385 million to resolve federal and state allegations involving the manufacture of certain powder infant formula and nutritional therapy products between 2018 and 2022. More than half of infant formula purchased in the United States is paid for through the USDA-funded WIC program, according to federal officials. The settlement resolves allegations only, with no determination of liability. Sheila Fitzgerald/Shutterstock

Abbott Laboratories has agreed to pay nearly $385 million to settle federal and state allegations involving the manufacture of certain powder infant formula and nutritional therapy products, including products purchased through government-funded nutrition programs.

According to the U.S. Department of Justice, Abbott will pay a total of $384,999,040 to resolve allegations stemming from products manufactured at facilities in Sturgis, Michigan, and Casa Grande, Arizona, between January 1, 2018, and December 31, 2022.

Of that amount, $348,700,868 will go to the federal government to resolve False Claims Act allegations. Another $36,298,172 will go to certain states to settle claims involving state Medicaid and WIC programs.

The claims resolved through the settlement are allegations only, and there has been no determination of liability.

Government Alleged Problems at Infant Formula Manufacturing Facilities

The federal government’s case focused in part on conditions at Abbott’s Sturgis manufacturing facility.

According to the Justice Department, the government alleged that Abbott knowingly manufactured infant formula purchased with taxpayer money in conditions that placed products at an unacceptable risk of microorganism contamination and affected their reliability, quality and safety.

The complaint alleged Abbott failed to adequately maintain manufacturing equipment and control water that could foster microorganism growth.

Federal officials also alleged that cracks and pits developed in spray dryers used to turn liquid formula into powder. According to the government, Abbott continued using the equipment despite conditions that allegedly increased the risk of microorganism contamination, particularly when moisture was present.

The government further alleged that Abbott lengthened the number of production batches processed between cleaning cycles and, in certain circumstances, failed to disclose contamination test results when responding to FDA requests during inspections in 2019 and 2022.

Abbott’s agreement to settle these allegations does not constitute a judicial finding that the company committed the alleged conduct.

WIC and Medicaid Funds Are Central to the Case

The settlement has particular significance because government programs pay for a substantial portion of infant formula purchased in the United States.

The Justice Department says more than half of all infant formula purchased nationwide is paid for with U.S. Department of Agriculture funds through the Special Supplemental Nutrition Program for Women, Infants, and Children, better known as WIC.

WIC provides nutritional assistance, including infant formula, to eligible pregnant and postpartum women, infants and young children. State Medicaid programs can also pay for certain infant formula products.

The federal government alleged that Abbott caused government programs to purchase products that failed to comply with applicable statutory, regulatory and contractual requirements.

That connection to taxpayer-funded programs is why the case was pursued under the False Claims Act rather than solely as a food-manufacturing matter.

Whistleblowers Will Receive $69 Million

The case originated through the False Claims Act’s qui tam provisions, which allow private individuals with information about alleged fraud against federal programs to bring a lawsuit on behalf of the government.

According to the Justice Department, relators Scott Millard, Kristine Cooper and Loren Cooper — all former Abbott employees — will receive $69 million as their share of the federal settlement.

The lawsuit was filed in the U.S. District Court for the Western District of Michigan.

The settlement resulted from a coordinated effort involving the Justice Department’s Civil Division, the U.S. Attorney’s Office for the Western District of Michigan and the USDA Office of Inspector General.

Nearly $385 Million Will Resolve the Government Claims

The settlement breaks down to $348.7 million for the United States and approximately $36.3 million for participating states.

The case covers alleged conduct occurring from the beginning of 2018 through the end of 2022 and involves powder infant formula and nutritional therapy products manufactured at Abbott facilities in Michigan and Arizona.

For families who receive infant formula through WIC or Medicaid, the case also illustrates how government purchasing programs can become part of False Claims Act enforcement when authorities allege taxpayer-funded products didn’t comply with required manufacturing standards.

Consumers should not interpret the settlement itself as a new recall announcement or assume that formula currently in their homes is covered by a recall based solely on this case. Families concerned about the safety or recall status of a particular infant formula should check current information from the FDA and the product manufacturer rather than relying on the settlement announcement.

Most importantly, the settlement resolves allegations rather than establishing liability. Abbott agreed to the nearly $385 million payment without a court determining that the company was liable for the government’s claims.