Abbott Laboratories to pay $385 million in baby formula contamination settlement

Abbott Laboratories has agreed to pay $385 million to resolve civil False Claims Act lawsuits brought by the U.S. Department of Justice and several state Attorneys General. The settlement stems from a 2022 investigation into manufacturing practices at the company’s facility in Sturgis, Michigan, which is the largest baby formula plant in the United States.

The investigation followed reports of potential Cronobacter sakazakii contamination, which led to a massive recall of powdered infant formula, including the Similac brand. This recall contributed to a significant nationwide shortage of baby formula in 2022. Prosecutors alleged that the facility had unsanitary conditions, such as roof leaks, that put products at risk of microorganism contamination.

Abbott stated that the settlement does not constitute an admission of fault or liability. The company noted that government regulators tested unopened products from the homes of infants involved in the investigation and found no evidence of Cronobacter sakazakii. Additionally, the U.S. government has closed its parallel criminal investigation into the matter.