Abbott Nutrition to Pay $385M Settlement for 2022 Infant Formula Shortage, Contamination Incident
The U.S. Department of Justice (DOJ) Attorney’s Office for the Western District of Michigan announced on September 14 that Abbott Nutrition, the infant formula manufacturer at the center of the nationwide infant formula shortage in 2022, has agreed to a nearly $385 million settlement for unsafe production practices that led to the shutdown of its Sturgis, Michigan facility.
At a Glance: Abbott Nutrition Infant Formula Safety Incident
In 2022, the U.S. Food and Drug Administration (FDA) received complaints of four hospitalizations and one death among infants who consumed formula produced at Abbott Nutrition’s Sturgis manufacturing plant. Upon investigating these complaints, FDA detected Cronobacter sakazakii in environmental samples from the facility and recorded several adverse inspectional observations. A review of the firm’s internal records also indicated environmental contamination with C. sakazakii and the firm’s destruction of product due to the presence of the pathogen.
Production was temporarily halted at the Sturgis facility—one of the U.S.’s most significant producers of infant formula—greatly contributing to the subsequent nationwide infant formula shortage.
During the outbreak investigation, no unopened, distributed Abbott infant formula products tested positive for the strain of C. sakazakii that infected the sickened babies, and a definitive link between Abbott and the illnesses was never made by FDA.
Abbott Settles Over Manufacturing Formula at Risk of Microbial Contamination
The U.S. filed its complaint in November 2025, alleging that Abbott caused state programs under the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) and Medicaid to purchase powder infant formula manufactured at the Sturgis facility despite the products’ failure to meet statutory, regulatory, and contractual requirements related to food safety and manufacturing practices.
According to the complaint, Abbott “knowingly manufactured infant formula purchased with taxpayer dollars in an environment that put the products at unacceptable risk of microbial contamination.” The complaint alleged that Abbott:
- Failed to maintain its manufacturing equipment
- Failed to control the presence of water that fostered microbial growth
- Promoted a “culture of concealment” that systematically failed to identify, document, investigate, and prevent potential contamination.
Under the civil settlement agreement, Abbott will pay $348,700,868 to the U.S. to resolve allegations made under the qui tam provisions of the False Claims Act (which allow private individuals to bring suit on behalf of the U.S. for false claims submitted to federal programs and to share in any recovery) and an additional $36,298,172 to certain states for claims settled by their state Medicaid and WIC programs.
Whistleblowers' Complaint Led to False Claims Act Settlement
The complaint that resulted in the False Claims Act settlement was filed by three whistleblowers who were former Abbott employees working in quality and maintenance operations. The information they provided ultimately contributed to a coordinated investigation involving DOJ, FDA, the U.S. Department of Agriculture (USDA), and federal prosecutors.
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Andrew M. Beato, J.D., Partner at Stein Mitchell Beato & Missner LLP, who represented the three whistleblowers, explained to Food Safety Magazine that, as early as 2021, the three whistleblowers reported to federal regulators, including FDA, their concerns about the alleged noncompliant practices at Abbott Nutrition's facilities in Sturgis, Michigan and Casa Grande, Arizona.
"The whistleblowers [reported noncompliances at the two Abbott facilities] well before they filed the complaint under the False Claims Act in 2022 because they were motivated out of genuine concern for infants and families," Mr. Beato said. "We appreciate the seriousness with which DOJ took their concerns and investigated."
Mr. Beato also shared his hopes that the False Claims Act will continue to be an enforcement tool for food safety in appropriate cases.
DOJ’s Criminal Prosecution of Abbott Previously Dropped
Civil settlement aside, in June 2026, news came to light that a Trump Administration Executive Order halted a DOJ criminal prosecution of Abbott for its role in the 2022 infant formula safety and supply crisis, which involved potential charges against at least one individual.
The DOJ statement about the September 2026 civil settlement notes that the claims resolved by the $385 million settlement are allegations only and there has been no determination of liability.
Update, September 15, 2026: The article has been edited to include Mr. Beato's comments.
