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Abbott agrees to pay $385M to settle infant formula case

Abbott agrees to pay $385M to settle infant formula case

ABBOTT PARK, Ill. – Abbott will pay $385 million to resolve a previously disclosed investigation and lawsuit brought by the U.S. Department of Justice (DOJ), as well as lawsuits filed by certain relators and the attorneys general of several states, relating to its 2022 recall of powdered infant formula manufactured at its Sturgis, Mich., facility.

The settlement, the company says, does not represent any finding of fault or liability.

Abbott also noted, in relation to the settlement:

  • The government, as previously indicated, has closed its criminal investigation regarding this matter
  • No unopened, distributed Abbott infant formulas have ever tested positive for Cronobacter sakazakii. (The company says consistent with this, the U.S. Food and Drug Administration (FDA) confirmed in early March 2022 that the unopened product from the homes of the infants under investigation at the time of the recall tested negative for Cronobacter sakazakii. The Centers for Disease Control (CDC) later concluded there was no definitive link between the Sturgis facility and the clinical cases under investigation at that time.)

“Nothing matters more than the safety and quality of Abbott's products,” the company stated in a press release. “We make infant formula with the same care we would for our own families and are deeply committed to earning and maintaining caregivers' trust. As we move forward, Abbott remains focused on serving the families who depend on us every day.”

Abbott also answered frequently asked questions in relation to the settlement.

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