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 recalls17since 2012
Last 12 months0reported
Class I16% of total
Ongoing5latest 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%

By year

Ongoing lorazepam recalls

5 active

All lorazepam recalls, newest first

17 total
ReportedClassRecallCompanyReasonWhere
DrugCLASS IILorazepam Injection, USP, 2 mg/mL, 25 x vials/carton recalledLorazepamHikma Pharmaceuticals USAPotency & AssayNationwide
DrugCLASS IILorazepam Tablets, USP, 2mg, Unit Dose per carton ( blister packs) recalledThe Harvard Drug GroupPotency & AssayNationwide
DrugCLASS IILorazepam Tablets, USP, 1mg, Unit Dose per carton ( blister packs) recalledThe Harvard Drug GroupPotency & AssayNationwide
DrugCLASS IILorazepam Tablets, USP, 0.5mg, Unit Dose per carton ( blister packs) recalledThe Harvard Drug GroupPotency & AssayNationwide
DrugCLASS IILorazepam Injection, USP 2 mg/mL vial vials recalled by AkornAkornPotency & AssayNationwide
DrugCLASS IILorazepam Injection, USP, 2mg/mL vial recalledLorazepamHikma Pharmaceuticals USAPotency & AssayNationwide
DrugCLASS IILORazepam Injection, 2mg / mL Single Dose vial recalled by RemedyRepackRemedyRepackManufacturing (CGMP) DeviationsPA
DrugCLASS IILorazepam Injection, USP, 2mg/mL vial, 25 vials recalledLorazepamHikma Pharmaceuticals USAPotency & AssayNationwide
DrugCLASS IILorazepam Injection, USP, 4mg/mL vial, 25 vial recalledLorazepamHikma Pharmaceuticals USAPotency & AssayNationwide
DrugCLASS IILorazepam Injection, USP, 2mg/mL vial, 25 vial recalledLorazepamHikma Pharmaceuticals USAPotency & AssayNationwide
DrugCLASS IILorazepam 1 mg/mL Infusion Solution recalledFamily Pharmacy of StatesvilleSterilityNC
DrugCLASS ILorazepam Oral Concentrate, USP, 2 mg/mL recalledLorazepamAmneal Pharmaceuticals of New YorkOtherNationwide
DrugCLASS IILorazepam Tablets, USP CIV, 0.5 mg recalled by Leading PharmaLorazepamLeading PharmaOtherNationwide
DrugCLASS IILorazepam 2 mg/mL Inj., Qty: Vial recalled by RemedyRepackRemedyRepackPackaging DefectsNationwide
DrugCLASS IILORazepam, Tablet, 0.25 mg (1/2 of 0.5 mg) recalled by Aidapak ServicesAidapak ServicesLabeling Errors4 states
DrugCLASS IIILorazepam, 0.5 mg tablets, 100 count, RX only recalledLegacy Pharmaceutical PackagingOtherIN
DrugCLASS IILorazepam 2mg/ML Injectable (3 Different Products) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide

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.