By The Epoch Times | Created at 2026-09-15 11:56:47 | Updated at 2026-09-15 13:49:12
1 hour ago
Abbott Laboratories has agreed to pay more than $384 million to settle allegations that it manufactured infant formula under conditions that posed a risk of contamination and then sold the products to federal and state programs, the U.S. Justice Department said on Monday.
The settlement relates to a lawsuit originally filed by three whistleblower employees following a 2022 recall of Abbott baby formula products after complaints that they were contaminated with a potentially deadly bacterium. The Department of Justice partially intervened last year, filing a complaint in intervention in November.
Specifically, Abbott was accused of knowingly manufacturing infant formula at its Sturgis, Michigan, facility in an “environment that put the products at unacceptable risk of microorganism contamination,” the Department of Justice (DOJ) said in a Sept. 14 statement.
“As described in the Complaint, Abbott failed to maintain its manufacturing equipment, failed to control the presence of water that fostered microorganism growth, and promoted a culture of concealment that systematically failed to identify, document, investigate, and prevent potential contamination,” the DOJ said.
The company distributed the products through federal and state programs, such as state-run Medicaid programs and the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). WIC provides funds for nutritional products, including infant formula. WIC pays for over half of all infant formula bought in the United States.
According to the settlement agreement, Abbott “misrepresented to USDA, State agencies administering the USDA funded WIC program, and State Medicaid programs that its powdered infant formula and nutritional products complied with USDA requirements for WIC infant formula and State Medicaid requirements.”
Under the terms of the settlement, Abbott will pay more than $348 million to the United States, more than $35 million to impacted states, and more than $800,000 to Massachusetts, for a total of about $384 million.
The company denies the allegations, according to the settlement. The agreement clarified that the deal was made “in compromise of disputed claims” and does not constitute an admission of liability by Abbott.
U.S. Attorney Timothy VerHey said in a statement that food supplied to children should meet or exceed every federal nutrition and safety requirement.
“This case demonstrates that anyone who fails this standard will pay a high price,” he added.
The Abbott manufacturing facility in Sturgis, Mich., on May 13, 2022. Jeff Kowalsky/AFP via Getty Images
Between September 2021 and January 2022, four infants became ill from Cronobacter sakazakii, a type of bacteria. Two of them died, with the parents reporting to authorities that they had used Abbott’s products.
A Food and Drug Administration (FDA) investigation at Abbott’s Sturgis facility found unsanitary conditions. Officials also discovered that Abbott had destroyed some of its products.
The company recalled Similac, Alimentum, and EleCare infant formulas manufactured at Sturgis in February 2022. The facility shut down that month and resumed production later that year after Abbott met certain FDA requirements.
Food and Drug Administration Commissioner Dr. Robert Califf in Washington, in an undated file photograph. Joe Raedle/Getty Images
FDA Commissioner of Food and Drugs Robert Califf, testifying before a subcommittee hearing in May 2022, said, “We do not have definitive evidence proving that insanitary conditions of the Sturgis facility actually caused the Cronobacter illnesses of these infants.”
FDA, CDC Testing
Abbott said in a Sept. 14 statement that the agreement does not represent any finding of fault or liability.
Citing statements from the FDA and the Centers for Disease Control and Prevention, Abbott said no unopened infant formula products the company distributed have tested positive for the Cronobacter bacteria.
In a March 31, 2022 update, the FDA said it analyzed product samples collected from the Sturgis facility and the samples tested negative for the bacteria.
In a Sept. 29, 2025 statement, the CDC said the Cronobacter bacteria found in two patient samples were not “closely genetically related” to the several strains found in environmental samples collected from the facility.
Centers for Disease Control and Prevention headquarters in Atlanta, Ga., on May 21, 2024. Madalina Vasiliu/The Epoch Times
Abbott also said that the government had closed its criminal investigation into the matter.
“Nothing matters more than the safety and quality of Abbott’s products,” the company said in a statement. “We make infant formula with the same care we would for our own families and are deeply committed to earning and maintaining caregivers’ trust.”
According to the settlement agreement, the whistleblowers who originally filed the lawsuit did so under the False Claims Act’s qui tam provisions.
Qui tam lawsuits allow a private person to prosecute a case on the government’s behalf. If the case succeeds, the whistleblower earns rewards. In this case, the settlement instructs the United States to pay $69 million from its proceeds to the whistleblowers.
In August, Abbott announced it would settle roughly 2,000 infant formula lawsuits by paying around $670 million.
The lawsuits accused the company of knowingly distributing infant formulas that raised the risk of necrotizing enterocolitis, a gastrointestinal disease, in preterm babies. The company denied the allegations.
