Abbott agrees to pay $385 million to resolve claims over 2022 infant formula recall

  • Abbott agreed to pay nearly $385 million to resolve a civil False Claims Act case.
  • Justice Department alleged unsanitary Sturgis plant conditions exposed powdered formula to contamination risks.
  • Justice Department closed its parallel criminal investigation earlier this year.

Abbott Laboratories agreed to pay nearly $385 million to resolve a civil False Claims Act case brought by the Justice Department and several states over conditions at its Sturgis, Michigan, powdered infant formula plant and its 2022 recall. The government alleged Abbott allowed unsanitary conditions, including unresolved roof leaks, that created an unacceptable risk of microorganism contamination, and withheld certain positive microbial findings from Food and Drug Administration inspectors. The Justice Department closed a parallel criminal investigation earlier this year after senior leaders declined to allow prosecutors to pursue felony charges. Abbott said the settlement is not an admission or finding of fault or liability and said unopened formula tested from the homes of infants under investigation during the recall was negative for Cronobacter sakazakii. The company has also said testing found no definitive link between the Sturgis facility and the clinical cases.

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