Abbott Laboratories has agreed to pay $385 million to resolve civil claims related to a 2022 contamination investigation at its Sturgis, Michigan, baby formula plant—the largest in the U.S.—which triggered a nationwide recall and exacerbated supply shortages.
The settlement, announced Monday, resolves a False Claims Act case brought by the U.S. Department of Justice and multiple state attorneys general. Abbott maintains the agreement does not constitute an admission of fault or liability, though the Justice Department alleged the company’s manufacturing conditions posed unacceptable risks to infant health.
Key developments in the case
Abbott’s Sturgis facility, which produces brands including Similac, was shut down in February 2022 after Cronobacter sakazakii contamination concerns. The recall, compounded by pandemic-era supply chain disruptions, led to severe shortages of powdered infant formula across the country.
Federal prosecutors initially pursued felony charges in a parallel criminal investigation, but the Justice Department closed the case in February 2023, opting instead for a civil settlement. A senior DOJ official stated at the time that a civil resolution was the “best mechanism to achieve accountability, deterrence, and protection of the public.”
Government allegations and Abbott’s response
The Justice Department’s civil complaint alleged that Abbott’s manufacturing environment “put products at unacceptable risk of microorganism contamination”, impacting their safety and reliability. In response, Abbott emphasized that government tests of unopened, distributed formula found no evidence of Cronobacter sakazakii, and that no such contamination was detected in unopened products from consumers’ homes during the investigation.
The company also noted that the criminal investigation was closed with no charges filed, and that the settlement does not reflect any finding of wrongdoing. Abbott stated in a release that it remains “committed to the highest standards of quality and safety” in infant formula production.
Broader implications of the settlement
The case highlights ongoing concerns about food safety oversight in the U.S., particularly for vulnerable populations like infants. The Justice Department’s decision to pursue a civil settlement—rather than criminal charges—has drawn attention to the tools available to regulators in addressing corporate misconduct.
The settlement also resolves lawsuits filed by state attorneys general and private relators, though Abbott has not admitted liability in those cases. The company’s agreement to pay $385 million marks one of the largest civil settlements in recent years tied to food safety violations.
Timeline of key events
- February 2022: Abbott voluntarily shuts down the Sturgis plant after contamination concerns.
- May 2022: FDA investigation finds unsanitary conditions at the facility.
- February 2023: Justice Department closes criminal investigation without filing charges.
- June 2024: Abbott agrees to $385 million civil settlement with the DOJ and states.