Lorazepam recalls
The FDA has published 17 recalls involving Lorazepam since 2012. The latest was reported on 6 Aug 2025. Most were for potency & assay. Hikma Pharmaceuticals USA has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.
Total recalls 17 since 2012
Last 12 months 0 reported
Class I 1 6% of total
Ongoing 5 latest 6 Aug 2025
Recalls per month, last 24 months click a bar for that month
Severity split
Class I 1 6% Class II 15 88% Class III 1 6%
Why lorazepam is recalled
Ongoing lorazepam recalls 5 active
Reported Class Recall Company Reason Where 6 Aug 2025 Drug CLASS II Lorazepam Injection, USP, 2 mg/mL, 25 x vials/carton recalled Lorazepam Hikma Pharmaceuticals USA Potency & Assay Nationwide 26 Feb 2025 Drug CLASS II Lorazepam Tablets, USP, 2mg, Unit Dose per carton ( blister packs) recalled The Harvard Drug Group Potency & Assay Nationwide 26 Feb 2025 Drug CLASS II Lorazepam Tablets, USP, 1mg, Unit Dose per carton ( blister packs) recalled The Harvard Drug Group Potency & Assay Nationwide 26 Feb 2025 Drug CLASS II Lorazepam Tablets, USP, 0.5mg, Unit Dose per carton ( blister packs) recalled The Harvard Drug Group Potency & Assay Nationwide 7 Jun 2023 Drug CLASS II Lorazepam Injection, USP 2 mg/mL vial vials recalled by Akorn Akorn Potency & Assay Nationwide
All lorazepam recalls, newest first 17 total
Reported Class Recall Company Reason Where 6 Aug 2025 Drug CLASS II Lorazepam Injection, USP, 2 mg/mL, 25 x vials/carton recalled Lorazepam Hikma Pharmaceuticals USA Potency & Assay Nationwide 26 Feb 2025 Drug CLASS II Lorazepam Tablets, USP, 2mg, Unit Dose per carton ( blister packs) recalled The Harvard Drug Group Potency & Assay Nationwide 26 Feb 2025 Drug CLASS II Lorazepam Tablets, USP, 1mg, Unit Dose per carton ( blister packs) recalled The Harvard Drug Group Potency & Assay Nationwide 26 Feb 2025 Drug CLASS II Lorazepam Tablets, USP, 0.5mg, Unit Dose per carton ( blister packs) recalled The Harvard Drug Group Potency & Assay Nationwide 7 Jun 2023 Drug CLASS II Lorazepam Injection, USP 2 mg/mL vial vials recalled by Akorn Akorn Potency & Assay Nationwide 24 May 2023 Drug CLASS II Lorazepam Injection, USP, 2mg/mL vial recalled Lorazepam Hikma Pharmaceuticals USA Potency & Assay Nationwide 24 May 2023 Drug CLASS II LORazepam Injection, 2mg / mL Single Dose vial recalled by RemedyRepack RemedyRepack Manufacturing (CGMP) Deviations PA 17 Aug 2022 Drug CLASS II Lorazepam Injection, USP, 2mg/mL vial, 25 vials recalled Lorazepam Hikma Pharmaceuticals USA Potency & Assay Nationwide 17 Aug 2022 Drug CLASS II Lorazepam Injection, USP, 4mg/mL vial, 25 vial recalled Lorazepam Hikma Pharmaceuticals USA Potency & Assay Nationwide 17 Aug 2022 Drug CLASS II Lorazepam Injection, USP, 2mg/mL vial, 25 vial recalled Lorazepam Hikma Pharmaceuticals USA Potency & Assay Nationwide 23 Mar 2022 Drug CLASS II Lorazepam 1 mg/mL Infusion Solution recalled Family Pharmacy of Statesville Sterility NC 27 Dec 2017 Drug CLASS I Lorazepam Oral Concentrate, USP, 2 mg/mL recalled Lorazepam Amneal Pharmaceuticals of New York Other Nationwide 29 Nov 2017 Drug CLASS II Lorazepam Tablets, USP CIV, 0.5 mg recalled by Leading Pharma Lorazepam Leading Pharma Other Nationwide 16 Dec 2015 Drug CLASS II Lorazepam 2 mg/mL Inj., Qty: Vial recalled by RemedyRepack RemedyRepack Packaging Defects Nationwide 29 Jan 2014 Drug CLASS II LORazepam, Tablet, 0.25 mg (1/2 of 0.5 mg) recalled by Aidapak Services Aidapak Services Labeling Errors 4 states 12 Jun 2013 Drug CLASS III Lorazepam, 0.5 mg tablets, 100 count, RX only recalled Legacy Pharmaceutical Packaging Other IN 22 Aug 2012 Drug CLASS II Lorazepam 2mg/ML Injectable (3 Different Products) recalled Franck's Lab Inc., d.b.a. Franck's Compounding Lab Sterility Nationwide
Should you stop taking Lorazepam?
Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.