Quick answers
- What is Lorazepam used for?
- The FDA-approved label (Ativan, Bausch Health US LLC, July 9, 2025) says: “Ativan (lorazepam) is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Lorazepam have a boxed warning?
- Yes. The FDA label for Ativan has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Lorazepam?
- The FDA drug shortage list shows “Current shortage” for a product of this medicine (updated October 21, 2026). Ask your pharmacist about alternatives.
- Has Lorazepam been recalled?
- FDA enforcement reports list 11 recalls of products of this medicine; the newest started July 22, 2025 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Lorazepam?
- 37 companies list prescription products of Lorazepam in the FDA NDC Directory, including Aphena Pharma Solutions - Tennessee, LLC, Hikma Pharmaceuticals USA Inc. and Remedyrepack Inc..
What Lorazepam is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Ativan (lorazepam) is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. …
— FDA label: Ativan, Bausch Health US LLC, effective July 9, 2025. Read the full label on DailyMed →
The FDA has 97 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
89 of 97 FDA labels for this medicine have a boxed warning.
Forms and how it is given
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| lorazepam 0.5 mg tablet | Generic | $0.0364 per tablet |
| lorazepam 1 mg capsule, extended release | Brand: Loreev XR | $14.23 per capsule |
| lorazepam 1 mg tablet | Generic | $0.0374 per tablet |
| lorazepam 1.5 mg capsule, extended release | Brand: Loreev XR | $14.22 per capsule |
| lorazepam 2 mg capsule, extended release | Brand: Loreev XR | $14.18 per capsule |
| lorazepam 2 mg tablet | Generic | $0.0735 per tablet |
| lorazepam 2 mg/mL concentrate | Generic | $0.6731 per mL |
| lorazepam 2 mg/mL injection | Generic | $2.12 per mL |
| lorazepam 2 mg/mL liquid | Generic | $0.6731 per mL |
| lorazepam 2 mg/mL solution, concentrate | Generic | $0.6731 per mL |
| lorazepam 3 mg capsule, extended release | Brand: Loreev XR | $14.22 per capsule |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Aphena Pharma Solutions - Tennessee, LLC16 products
- Hikma Pharmaceuticals USA Inc.14 products
- Remedyrepack Inc.12 products
- NuCare Pharmaceuticals, Inc.11 products
- PD-Rx Pharmaceuticals, Inc.8 products
- Bryant Ranch Prepack6 products
- A-S Medication Solutions5 products
- American Health Packaging5 products
- Clinical Solutions Wholesale, LLC5 products
- Preferred Pharmaceuticals Inc.4 products
- Asclemed USA, Inc.4 products
- Almatica Pharma LLC4 products
- Proficient Rx LP4 products
- Chartwell RX, LLC4 products
- Unit Dose Solutions, Inc.3 products
- Teva Pharmaceuticals USA, Inc.3 products
- Bausch Health US, LLC3 products
- Aurolife Pharma, LLC3 products
- ANI Pharmaceuticals, Inc.3 products
- Sun Pharmaceutical Industries, Inc.3 products
- Rising Pharma Holdings, Inc.3 products
- Leading Pharma, LLC3 products
- Coupler LLC3 products
- Golden State Medical Supply, Inc.3 products
- St. Mary's Medical Park Pharmacy2 products
- Redpharm Drug2 products
- Fresenius Kabi USA, LLC2 products
- Amneal Pharmaceuticals LLC1 product
- RedPharm Drug, Inc.1 product
- Direct_Rx1 product
- PharmPak, Inc.1 product
- DirectRx1 product
- International Medication Systems, Limited1 product
- Advanced Rx of Tennessee, LLC1 product
- Civica, Inc.1 product
- Pharmaceutical Associates, Inc.1 product
- Hospira, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA017794 ATIVAN | Bausch | September 30, 1977 | 28, latest January 13, 2023 2023: Labeling · 2021: Labeling · 2016: Labeling |
| NDA018140 ATIVAN | Hikma | July 25, 1980 | 35, latest January 13, 2023 2023: Labeling · 2021: Labeling · 2017: Labeling |
| NDA214826 LOREEV XR | Almatica | August 27, 2021 | 2, latest January 13, 2023 2023: Labeling · 2023: Labeling |
Generic approvals (16)
- ANDA071591Chartwell Rx · October 13, 1987
- ANDA072755Hikma · June 28, 1991
- ANDA072926Watson Labs · October 31, 1991
- ANDA072927Watson Labs · October 31, 1991
- ANDA072928Watson Labs · October 31, 1991
- ANDA074243Hospira · April 12, 1994
- ANDA076045Sun Pharm Inds Ltd · August 29, 2001
- ANDA076150Intl Medication Sys · November 15, 2004
- ANDA077396Ani Pharms · December 13, 2006
- ANDA078203Leading · July 30, 2007
- ANDA079244Chartwell Molecular · April 28, 2009
- ANDA091383Amneal Pharms · December 23, 2009
- ANDA090260Pharm Assoc · June 15, 2010
- ANDA203572Aurobindo Pharma · December 22, 2017
- ANDA217598Fresenius Kabi USA · November 18, 2024
- ANDA218597Graviti Pharms · July 24, 2025
Shortage status
Current shortage · updated October 21, 2026 · first posted May 3, 2018
| Product | Lorazepam, Injection, 2 mg/1 mL Syringes (NDC 0409-1985-30) |
|---|---|
| Availability | Limited Availability |
| Reason given | Demand increase for the drug |
| Company | Hospira, Inc., a Pfizer Company |
Ask your pharmacist whether your product is affected and what the options are.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
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July 22, 2025 · Class II · Ongoing · D-0551-2025
Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds
Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ 07922, NDC# 0641-6044-25 — Hikma Pharmaceuticals USA Inc.
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January 21, 2025 · Class II · Ongoing · D-0227-2025
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
Lorazepam Tablets, USP, 1mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-905 Leading Pharma, LLC., Packaged and Distributed by: Major — The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
-
January 21, 2025 · Class II · Ongoing · D-0228-2025
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
Lorazepam Tablets, USP, 2mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-906 Leading Pharma, LLC., Packaged and Distributed by: Major — The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
-
January 21, 2025 · Class II · Ongoing · D-0226-2025
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
Lorazepam Tablets, USP, 0.5mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-904 Leading Pharma, LLC., Packaged and Distributed by: Maj — The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
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May 11, 2023 · Class II · Terminated · D-0574-2023
Failed Impurities/Degradation Specifications: Out-of-specification results for total related compounds observed during retain steting due to the elevated Related Compound-C.
Lorazepam Injection, USP, 2mg/mL, 1 mL vial (NDC 0641-6044-01), packaged in 25 x 1 mL Vials per carton (NDC 0641-6044-25), Rx only, Manufactured by West-Ward, Eatontown, NJ 07724. — Hikma Pharmaceuticals USA Inc.
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July 11, 2022 · Class II · Terminated · D-1307-2022
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Manufactured by West-Ward Eatontown, NJ 07724, Carton NDC# 0641-6044-25, Vial NDC# 0641-6044-01 — Hikma Pharmaceuticals USA Inc.
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July 11, 2022 · Class II · Terminated · D-1309-2022
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured by Hikma Berkeley Heights, NJ 07922. Carton NDC# 0641-6048-25, Vial NDC# 0641-6048-01 — Hikma Pharmaceuticals USA Inc.
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July 11, 2022 · Class II · Terminated · D-1310-2022
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Lorazepam Injection, USP, 4mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured by Hikma Berkeley Heights, NJ 07922. Carton NDC# NDC# 0641-6045-25, Vial NDC# 0641-6045-01 — Hikma Pharmaceuticals USA Inc.
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July 11, 2022 · Class II · Terminated · D-1308-2022
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Ativan Injection (lorazepam injection, USP), 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Manufactured by West-Ward Eatontown, NJ 07724, Carton NDC# 0641-6001-25, Vial NDC# 0641-6001-01 — Hikma Pharmaceuticals USA Inc.
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September 28, 2017 · Class II · Terminated · D-0085-2018
Labeling: Label Error on Declared Strength. Bottle labeled as 0.5 mg tablets contained 1mg tablets of lorazepam
Lorazepam Tablets, USP CIV, 0.5 mg, 500-count bottle, Rx Only, Manufactured by: Leading Pharma, LLC Fairfield, NJ 07004 NDC 69315-904-05 — Leading Pharma, LLC
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August 3, 2017 · Class I · Terminated · D-0120-2018
Defective Delivery System: the dropper measurement markings may be reversed, shifted or missing.
Lorazepam Oral Concentrate, USP, 2 mg/mL, 30 mL bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Branchburg, NJ 08876. Distributed by: Amneal Pharmaceuticals, Glasgow, KY 42141. NDC 65162-687-84 — Amneal Pharmaceuticals of New York, LLC
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Ativan, Bausch Health US LLC, effective July 9, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →