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Lorazepam

FDA recalls

5 rows

DateCompany and reasonClass
Jul 21, 2025Hikma Pharmaceuticals USA Inc.
Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds
Class II · Ongoing
May 10, 2023Hikma Pharmaceuticals USA Inc.
Failed Impurities/Degradation Specifications: Out-of-specification results for total related compounds observed during retain steting due to the elevated Related Compound-C.
Class II · Terminated
Jul 10, 2022Hikma Pharmaceuticals USA Inc.
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Class II · Terminated
Sep 27, 2017Leading Pharma, LLC
Labeling: Label Error on Declared Strength. Bottle labeled as 0.5 mg tablets contained 1mg tablets of lorazepam
Class II · Terminated
Aug 2, 2017Amneal Pharmaceuticals of New York, LLC
Defective Delivery System: the dropper measurement markings may be reversed, shifted or missing.
Class I · Terminated

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Sources: CMS Medicare Part D Prescribers 2024; CMS Open Payments 2025 (general payments; a payment is not evidence of wrongdoing); FDA enforcement reports (openFDA).