FDA found five environmental subsamples positive at Sturgis plant
Three Abbott Laboratories employees will receive $69 million as their share of a $385 million False Claims Act settlement the U.S. Justice Department announced Monday, resolving an investigation into conditions at the nation’s largest infant formula plant in Sturgis, Michigan. The agreement resolves claims brought against the company under the False Claims Act without any admission or finding of fault or liability against Abbott.
“Nothing matters more than the safety and quality of Abbott’s products,” the company said in a statement announcing its settlement. “We make infant formula with the same care we would for our own families and are deeply committed to earning and maintaining caregivers’ trust. As we move forward Abbott remains focused on serving the families who depend on us every day.”
The Sturgis plant, operated by Abbott subsidiary Abbott Nutrition, came under federal investigation after four infants fell ill with Cronobacter sakazakii, a rare bacterium that contaminates dry foods, after consuming baby formula manufactured at the facility. The Centers for Disease Control and Prevention said Cronobacter infections may have been a contributor to the deaths of two infants. While Abbott states no unopened, distributed Abbott infant formula tested positive for Cronobacter sakazakii, the Food and Drug Administration said five environmental subsamples collected from the plant tested positive for the bacteria.
The investigation uncovered issues such as roof leaks and faulty equipment that increased the risk of products being contaminated, leading to recalls and the plant’s shuttering in February 2022. The closure further strained baby formula supplies already stressed by the COVID-19 pandemic, worsening a national supply shortage.
In October 2022, three Abbott employees filed a qui tam False Claims Act lawsuit against the company on behalf of the government. The United States partially intervened in the whistleblower case in 2025 and filed its own complaint in intervention that November, resulting in Monday’s settlement.
Under the agreement, Abbott will pay more than $384 million plus interest to the U.S. government and Medicaid-participating states, of which the three Abbott employees will receive $69 million as their share of the federal settlement.
“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 Woodward Jr. said in a statement. “The department will hold accountable bad actors that knowingly misrepresent compliance with essential health and safety standards designed to protect American families.”