Abbott to pay $385 million to settle DOJ infant formula claims

Abbott (NYSE: ABT) has agreed to pay $385 million to resolve claims brought by the U.S. Department of Justice, several state attorneys general, and certain private parties related to the company's manufacturing practices and 2022 recall of powdered infant formula produced at its Sturgis, Mich., facility.

According to a statement from the company, the settlement does not constitute a finding of fault or liability. The Justice Department has also closed its criminal investigation into the matter, the company said.

The 2022 recall prompted a significant shortage of infant formula in the United States. Abbott has maintained that no unopened, distributed Abbott infant formulas have ever tested positive for Cronobacter sakazakii, the bacterium at the center of the investigation.

The FDA confirmed in early March 2022 that unopened formula samples collected from the homes of the infants under investigation tested negative for Cronobacter sakazakii. The CDC later concluded there was no definitive link between the Sturgis facility and the clinical cases under investigation at the time.

In cases where open containers were tested, one container tested positive for two strains of Cronobacter sakazakii, neither of which was found at the Sturgis plant. One of those strains matched a strain found on a bottle of distilled water in the infant's home used to prepare the formula.

Genetic sequencing on samples from two of the ill infants did not match strains of Cronobacter found at the plant, and the two infant samples did not match each other, indicating no common source between those cases.

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