The U.S. Department of Justice’s Consumer Protection Branch has launched a criminal investigation against Abbott Nutrition due to the 2022 foodborne illness outbreak linked to powdered infant formula manufactured at the company’s Sturgis, Michigan facility.

The prolific outbreak included four infant hospitalizations and two deaths that may have been caused by Cronobacter sakazakii infection. All of the case patients were reported to have consumed Abbott Nutrition powdered formula products that were produced at the Sturgis facility. An inspection by the U.S. Food and Drug Administration (FDA) revealed the presence of five Cronobacter sakazaii strains in the Sturgis facility, as well as inadequate food safety practices. However, analysis performed by whole genome sequencing did not find the Cronobacter strains isolated from patients to be a genetic match to the multiple strains of Cronobacter sampled from the Sturgis facility.

The outbreak and subsequent recall resulted in a number of consequences, including a shortage of safe infant formula in the U.S., and an FDA prevention strategy for preventing Cronobacter contamination of powdered infant formula that supports elevating the pathogen to a nationally notifiable disease. FDA’s handling of the outbreak, recalls, and related issues also brought the agency under scrutiny, resulting in an evaluation of its processes that may bring major changes within FDA.