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Benzodiazepines

FDA recalls

20 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
Nov 17, 2024Endo USA, Inc.
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.		Class I · Ongoing
Jul 9, 2024Endo Pharmaceuticals, Inc.
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled as 0.125 mg instead of 0.25 mg. The blister strips inside the product carton reflect the correct strength of 0.25 mg.		Class I · Terminated
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
Apr 27, 2022Viatris Inc
Failed Dissolution Specifications: low out-of-specification dissolution test results observed.		Class II · Terminated
Jul 9, 2018Valeant Pharmaceuticals North America LLC
Labeling: Incorrect or Missing Lot and/or Exp Date: Product distributed without a lot number or expiration date on the outer carton.		Class III · 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
Jun 22, 2016Hospira Inc.
Crystallization: Product contains particulate identified to be crystallized active ingredient.		Class II · Terminated
Sep 23, 2015Pfizer Inc.
Subpotent Drug		Class II · Terminated
Dec 16, 2014Neolpharma, Inc.
Subpotent Drug		Class II · Terminated
Jul 24, 2014Sandoz Incorporated
Presence of Foreign Substance; tablets may contain stainless steel metal particulates		Class II · Terminated
Feb 9, 2014Actavis Elizabeth LLC
Failed Tablet/Capsule Specifications: Complaints were received for significant tablet erosion for Alprazolam 1 mg.		Class II · Terminated
Oct 8, 2013Actavis Elizabeth LLC
Failed Tablet/Capsule Specifications; partial tablet erosion resulting in tablet weights below specification in some tablets		Class II · Terminated
Aug 15, 2013Hospira Inc.
Lack of assurance of sterility: ineffective crimp on fliptop vials that may result in leaking at the neck of the vials.		Class II · Terminated
May 15, 2013Hospira Inc.
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.		Class II · Terminated
Feb 25, 2013Hospira Inc.
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.		Class II · Terminated
Aug 27, 2012Hospira Inc.
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.		Class II · Terminated
Jun 5, 2012Meridian Medical Technologies A Pfizer Company
Impurities/Degradation Products: High Out of Specification levels for carbostyril, a known degradation product of diazepam.		Class II · 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).