WASHINGTON — Abbott Laboratories will pay $385 million to resolve claims stemming from an investigation into contamination at its baby formula plant in Sturgis, Michigan, which contributed to a nationwide infant formula shortage in 2022.
The settlement resolves claims related to the Justice Department’s investigation and lawsuits involving the facility, the largest baby formula plant in the country. Abbott said the agreement does not constitute an admission or finding of fault or liability.
The investigation led Abbott to recall powdered infant formula from the Sturgis facility, including Similac and other brands. The recall further strained supplies that already faced disruptions from supply chain problems and consumer stockpiling during COVID-19 shutdowns.
Abbott said Monday that government regulators tested unopened formula samples from the homes of infants involved in the investigation at the time of the 2022 recall. The tests came back negative for Cronobacter sakazakii, a bacterium that can cause serious illness in infants.
The company also said no unopened Abbott infant formula that it distributed has ever tested positive for Cronobacter sakazakii.
The settlement also covers lawsuits from certain whistleblowers and attorneys general from several states.
The Justice Department under President Donald Trump closed its criminal investigation into the matter.
The Biden administration responded to the 2022 shortage with several measures, including easing import requirements for foreign formula manufacturers, bringing formula from Europe into the United States and invoking emergency rules to prioritize domestic production.
Abbott closed the Sturgis plant in February 2022 after the Food and Drug Administration opened its investigation. The company reopened the facility in June 2022.
