Quick answers
- What is Metoprolol used for?
- The FDA-approved label (Lopressor, Validus Pharmaceuticals LLC, January 26, 2026) says: “LOPRESSOR is a beta-adrenergic blocker indicated in the treatment of hemodynamically stable adult patients with myocardial infarction, to reduce the risk of cardiovascular mortality. 1.1 Myocardial Infarction LOPRESSOR is indicated in the treatment of hemodynamically stable adult patients with myocardial infarction (MI) to reduce cardiovascular mortality.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Metoprolol have a boxed warning?
- The label we quote has no boxed warning, but 15 of 340 FDA labels for this medicine do. Check the label of your own product.
- Is there a shortage of Metoprolol?
- The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated August 31, 2026). Ask your pharmacist about alternatives.
- Has Metoprolol been recalled?
- FDA enforcement reports list 20 recalls of products of this medicine; the newest started April 27, 2026 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Metoprolol?
- 70 companies list prescription products of Metoprolol in the FDA NDC Directory, including A-S Medication Solutions, Bryant Ranch Prepack and Proficient Rx LP.
What Metoprolol is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
LOPRESSOR is a beta-adrenergic blocker indicated in the treatment of hemodynamically stable adult patients with myocardial infarction, to reduce the risk of cardiovascular mortality. 1.1 Myocardial Infarction LOPRESSOR is indicated in the treatment of hemodynamically stable adult patients with myocardial infarction (MI) to reduce cardiovascular mortality.
— FDA label: Lopressor, Validus Pharmaceuticals LLC, effective January 26, 2026. Read the full label on DailyMed →
The FDA has 340 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.
The label quoted above has no boxed warning.
15 of 340 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 |
|---|---|---|
| metoprolol succinate 100 mg capsule, extended release | Brand: Kapspargo | $2.29 per capsule |
| metoprolol succinate 100 mg tablet, extended release | Generic | $0.0839 per tablet |
| metoprolol succinate 100 mg tablet, extended release | Brand: Toprol XL | $2.08 per tablet |
| metoprolol succinate 100 mg tablet, film coated, extended release | Generic | $0.0839 per tablet |
| metoprolol succinate 200 mg tablet, extended release | Generic | $0.1805 per tablet |
| metoprolol succinate 200 mg tablet, extended release | Brand: Toprol XL | $3.32 per tablet |
| metoprolol succinate 200 mg tablet, film coated, extended release | Generic | $0.1805 per tablet |
| metoprolol succinate 25 mg capsule, extended release | Brand: Kapspargo | $1.89 per capsule |
| metoprolol succinate 25 mg tablet, extended release | Generic | $0.0529 per tablet |
| metoprolol succinate 25 mg tablet, extended release | Brand: Toprol XL | $1.39 per tablet |
| metoprolol succinate 25 mg tablet, film coated, extended release | Generic | $0.0529 per tablet |
| metoprolol succinate 50 mg capsule, extended release | Brand: Kapspargo | $1.89 per capsule |
| metoprolol succinate 50 mg tablet, extended release | Generic | $0.0494 per tablet |
| metoprolol succinate 50 mg tablet, extended release | Brand: Toprol XL | $1.39 per tablet |
| metoprolol succinate 50 mg tablet, film coated, extended release | Generic | $0.0494 per tablet |
| metoprolol tartrate 10 mg/mL solution | Brand: Lopressor | $1.20 per mL |
| metoprolol tartrate 100 mg tablet | Generic | $0.0295 per tablet |
| metoprolol tartrate 100 mg tablet, extended release | Generic | $0.0839 per tablet |
| metoprolol tartrate 100 mg tablet, film coated | Generic | $0.0295 per tablet |
| metoprolol tartrate 12.5 mg tablet | Generic | $2.84 per tablet |
| metoprolol tartrate 200 mg tablet, extended release | Generic | $0.1805 per tablet |
| metoprolol tartrate 25 mg tablet | Generic | $0.0160 per tablet |
| metoprolol tartrate 25 mg tablet, extended release | Generic | $0.0529 per tablet |
| metoprolol tartrate 25 mg tablet, film coated | Generic | $0.0160 per tablet |
| metoprolol tartrate 37.5 mg tablet, film coated | Generic | $0.0756 per tablet |
| metoprolol tartrate 50 mg tablet | Generic | $0.0205 per tablet |
| metoprolol tartrate 50 mg tablet | Brand: Lopressor | $2.42 per tablet |
| metoprolol tartrate 50 mg tablet, extended release | Generic | $0.0494 per tablet |
| metoprolol tartrate 50 mg tablet, film coated | Generic | $0.0205 per tablet |
| metoprolol tartrate 75 mg tablet, film coated | Generic | $0.1538 per tablet |
NADAC list of November 4, 2026; these prices took effect between January 21, 2026 and 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.
- A-S Medication Solutions49 products
- Bryant Ranch Prepack48 products
- Proficient Rx LP26 products
- Remedyrepack Inc.24 products
- Aphena Pharma Solutions - Tennessee, LLC22 products
- Northwind Health Company, LLC18 products
- NuCare Pharmaceuticals, Inc.18 products
- Cardinal Health 107, LLC16 products
- BluePoint Laboratories16 products
- PD-Rx Pharmaceuticals, Inc.15 products
- Preferred Pharmaceuticals Inc.11 products
- TruPharma, LLC10 products
- St. Mary's Medical Park Pharmacy9 products
- Coupler LLC9 products
- Direct_Rx8 products
- Oryza Pharmaceuticals Inc.8 products
- Redpharm Drug8 products
- Asclemed USA, Inc.8 products
- Sun Pharmaceutical Industries, Inc.8 products
- Golden State Medical Supply, Inc.7 products
- Advagen Pharma Limited6 products
- American Health Packaging6 products
- NCS HealthCare of KY, LLC dba Vangard Labs6 products
- Advagen Pharma Ltd5 products
- Mylan Pharmaceuticals Inc.5 products
- Aurobindo Pharma Limited5 products
- Medical Purchasing Solutions, LLC5 products
- Validus Pharmaceuticals LLC4 products
- QPharma, Inc.4 products
- Camber Pharmaceuticals, Inc.4 products
- Epic Pharma, LLC4 products
- Actavis Pharma, Inc.4 products
- Dr. Reddy's Laboratories Limited4 products
- Granules India Ltd4 products
- Zydus Pharmaceuticals USA Inc.4 products
- Granules Pharmaceuticals Inc.4 products
- NorthStar Rx LLC4 products
- Dr. Reddy's Laboratories Inc.4 products
- Quallent Pharmaceuticals Health LLC4 products
- Ascend Laboratories, LLC4 products
- AvPAK4 products
- Melinta Therapeutics, LLC4 products
- Cranbury Pharmaceuticals, LLC4 products
- Slate Run Pharmaceuticals, LLC4 products
- Zydus Lifesciences Limited4 products
- Ingenus Pharmaceuticals, LLC4 products
- Exelan Pharmaceuticals Inc.3 products
- Alembic Pharmaceuticals Limited3 products
- Rising Pharma Holdings, Inc.3 products
- Alembic Pharmaceuticals Inc.3 products
- Zhejiang Jutai Pharamceutical Co., Ltd3 products
- Major Pharmaceuticals3 products
- Cipla USA Inc.3 products
- Hospira, Inc.2 products
- Safecor Health LLC2 products
- Mylan Institutional Inc.2 products
- HF Acquisition Co LLC, DBA HealthFirst2 products
- Fresenius Kabi USA, LLC2 products
- RedPharm Drug, Inc.2 products
- Legacy Pharmaceutical Packaging, LLC2 products
- Hikma Pharmaceuticals USA Inc.2 products
- Civica, Inc.1 product
- ProPharma Distribution1 product
- Baxter Healthcare Corporation1 product
- Fosun Pharma USA Inc.1 product
- Oneosource Specialty Pharma Limited1 product
- Gland Pharma Limited1 product
- Sagent Pharmaceuticals1 product
- Almaject, Inc.1 product
- NuCare Pharmaceutcals, 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 |
|---|---|---|---|
| NDA017963 LOPRESSOR | Validus Pharms | August 7, 1978 | 61, latest December 22, 2023 2023: Labeling · 2023: Labeling · 2016: Manufacturing (CMC) |
| NDA019962 TOPROL-XL | Melinta Therap | January 10, 1992 | 39, latest March 10, 2023 2023: Labeling · 2023: Labeling · 2022: Labeling |
| NDA210428 KAPSPARGO SPRINKLE | Spil | January 26, 2018 | 2, latest April 14, 2023 2023: Labeling · 2018: Labeling |
| NDA218698 LOPRESSOR | Xtm Consulting | August 28, 2025 | 1, latest June 27, 2026 2026: Manufacturing (CMC) |
| NDA219373 LOPRESSOR | Rubicon Research | April 10, 2025 | 1, latest November 12, 2025 2025: Labeling |
Generic approvals (24)
- ANDA074453Adaptis · April 27, 1995
- ANDA076704Mylan · January 16, 2004
- ANDA077761Hikma Farmaceutica · May 30, 2007
- ANDA077739Aurobindo Pharma · September 11, 2007
- ANDA078085Hospira · April 29, 2008
- ANDA090317Onesource Specialty · April 19, 2010
- ANDA091045Fresenius Kabi USA · October 25, 2010
- ANDA090617DR Reddys Labs Ltd · August 1, 2012
- ANDA078889Reddys · August 15, 2012
- ANDA078950Baxter Hlthcare Corp · April 29, 2013
- ANDA202871Alembic Pharms Ltd · May 28, 2013
- ANDA204205Gland · August 27, 2014
- ANDA200981Rubicon Research · October 28, 2014
- ANDA204161Actavis Elizabeth · November 25, 2016
- ANDA204106Novast Labs · February 6, 2018
- ANDA203894Zydus Pharms · March 23, 2018
- ANDA207465Cipla · October 26, 2018
- ANDA207206Visum Pharm · December 19, 2018
- ANDA205541Hetero Labs Ltd III · November 6, 2020
- ANDA211143Alkem Labs Ltd · November 25, 2020
- ANDA213854Yichang Humanwell · February 12, 2021
- ANDA216916Granules · June 12, 2023
- ANDA216509Granules · August 7, 2023
- ANDA214110Zhejiang Jutai Pharm · July 26, 2024
Shortage status
To be discontinued · updated August 31, 2026 · first posted August 31, 2026
| Product | Metoprolol Succinate, Tablet, Extended Release, 100 mg (NDC 45963-677-96) |
|---|---|
| Company | Teva Pharmaceuticals USA, Inc. |
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.
-
April 27, 2026 · Class II · Ongoing · D-0547-2026
Failed Dissolution Specifications
Ascend Laboratories, LLC, Metoprolol Succinate Extended-Release Tablets, USP, 25 mg* Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-590 — Ascend Laboratories, LLC
-
January 29, 2026 · Class II · Ongoing · D-0355-2026
Failed Dissolution Specifications
Metoprolol Succinate Extended-Release Tablets, 50 mg, 100 tablets bottles (NDC: 45963-676-11) and 1,000 tablets bottles (NDC: 45963-676-96), Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054 — Teva Pharmaceuticals USA, Inc
-
January 29, 2026 · Class II · Ongoing · D-0357-2026
Failed Dissolution Specifications
Metoprolol Succinate Extended-Release Tablets, 200 mg, 100 tablets bottles, Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054, NDC: 45963-678-11 — Teva Pharmaceuticals USA, Inc
-
January 29, 2026 · Class II · Ongoing · D-0354-2026
Failed Dissolution Specifications
Metoprolol Succinate Extended-Release Tablets, 25 mg, 100 tablets bottles (NDC: 45963-709-11) and 1,000 tablets bottles (NDC: 45963-709-96), Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054 — Teva Pharmaceuticals USA, Inc
-
January 29, 2026 · Class II · Ongoing · D-0356-2026
Failed Dissolution Specifications
Metoprolol Succinate Extended-Release Tablets, Rx Only, 100 mg, 100 tablets bottles (NDC: 45963-677-11) and 1,000 tablets bottles (NDC: 45963-677-96), Teva Pharmaceuticals, Parsippany, NJ 07054. — Teva Pharmaceuticals USA, Inc
-
June 24, 2025 · Class II · Ongoing · D-0510-2025
Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH) long-term.
Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Packaged in a) 100-count bottle, NDC 70010-780-01; b) 500-count bottle, NDC 70010-780-05; Rx only, Manufactured by: Granules India Limited, Hyderadab-500 081, In — Granules Pharmaceuticals Inc.
-
May 6, 2024 · Class II · Ongoing · D-0517-2024
Presence of Foreign Substance: metal in tablet
Metoprolol Tartrate Tablets USP, 25mg, 1000 count bottle, Rx only, distributed by: TruPharma, LLC, Tampa, FL 33609, Manufactured by: Rubicon Research Private Limited, Ambernath Dist Thane 421506 India, NDC 52817-360-00 — Rubicon Research Private Limited
-
January 11, 2023 · Class II · Terminated · D-0269-2023
Failed Dissolution Specifications: This recall is being initiated in support of the recall by the manufacturer which included lots that were packaged for BluePoint Laboratories.
Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, packaged in (a) 100-count bottle, NDC 68001-501-00; (b) 500-count bottle, NDC 68001-501-03. Manufactured by Alkem Laboratories Ltd., India. For BluePoint Laborat — Amerisource Health Services LLC
-
January 5, 2023 · Class II · Terminated · D-0169-2023
Failed Dissolution Specification
Metoprolol Succinate Extended-Release Tablets, USP 25 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Parsippany NJ 07054, — Ascend Laboratories, LLC
-
January 5, 2023 · Class II · Terminated · D-0170-2023
Failed Dissolution Specification
Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Parsippany NJ 07054, — Ascend Laboratories, LLC
-
January 5, 2023 · Class II · Terminated · D-0171-2023
Failed Dissolution Specification
Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 500 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Parsippany NJ 07054, — Ascend Laboratories, LLC
-
January 26, 2022 · Class II · Terminated · D-0191-2024
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 1000 Tablets, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454. NDC: 45963-676-96 — CARDINAL HEALTHCARE
-
January 12, 2022 · Class II · Terminated · D-0393-2022
Failed Dissolution Specifications.
Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ, 070 — Ascend Laboratories, LLC
-
December 31, 2021 · Class II · Terminated · D-0362-2022
Complaint received of foreign matter (metal) embedded in tablet.
Metoprolol Tartrate Tablets, USP 25 mg, 1000 - count bottle, Rx Only, Distributed by: TruPharma, LLC. Tampa, FL 33609; Manufactured by: Rubicon Research Prvate Limited Ambernath, Dist. Thane, 421506 India. NDC 52817-360- — Rubicon Research Private Limited
-
December 20, 2021 · Class II · Terminated · D-0451-2022
Failed Dissolution Specifications
Metoprolol Succinate Extended-Release Tablets, USP 50 mg, 500-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 INDIA. NDC 68001-501-03 — American Health Packaging
-
September 9, 2021 · Class II · Terminated · D-0812-2021
Presence of Foreign Substance: Product complaints received for the presence of metal wire in one tablet.
Metoprolol Tartrate Tablets USP 100 mg, 1000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA Inc. 279 Princeton-Highstown Road East Windsor, NJ 08520, NDC 65862-064-99 — Aurobindo Pharma USA Inc.
-
October 15, 2018 · Class III · Terminated · D-0222-2019
Failed pH Specifications: Upward shift in the pH of the solution within the shelf life of the impacted lots.
Metoprolol Tartrate Injection, USP, 5 mg/ 5 mL (1 mg/mL), 5 mL per sterile single use glass vial, Rx Only, Manufactured for: Claris Lifesciences, Inc., North Brunswick, NJ 08902. By: Claris Injectables Ltd., Gujarat, Ind — Baxter Healthcare Corporation
-
April 23, 2018 · Class II · Terminated · D-0727-2018
Presence of Foreign Tablets/Capsules: One foreign tablet identified as Clopidogrel 75 mg was found in a 100 count bottle of Metoprolol Succiante Extended-Release Tablets.
Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100 Tablets bottle, Rx only, Manufactured by: Dr. Reddy's Laboratories Limited Bachupally-500 090 India\ NDC 55111-468-01 — Dr. Reddy's Laboratories, Inc.
-
May 23, 2014 · Class II · Terminated · D-1381-2014
Failed Dissolution Specifications: Failure of dissolution test observed at the 18 month time point.
Dr. Reddy's Metoprolol Succinate Extended Release Tablets, USP 25 mg. 100-count bottle, Rx only, Manufactured By: Dr. Reddy's Laboratories Limited, Batchupally - 500 090 India. NDC55111-466-01 — Dr. Reddy's Laboratories, Inc.
-
December 13, 2013 · Class II · Terminated · D-1080-2014
Failed Dissolution Specification; 12-Month stability interval.
Dr. Reddy's Metoprolol Succinate Extended-Release Tablets USP, 50 mg 100 tablets Rx Only Mfd. By: Dr. Reddy's Laboratories Limited Bachepalli -500 090 INDIA NDC 55111-467-01 — Dr. Reddy's Laboratories, Inc.
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
| RxCUI (RxNorm) | 866412, 866414, 866419, 866421, 866427, 866429, 866436, 866438, 866508, 866511 … (+10) |
|---|---|
| SPL set ID of the quoted label | b5f4fed2-369c-4808-a682-8a5b8cfdbb4f |
| FDA labels (SPL) | 340 |
| FDA applications | NDA017963, NDA019962, NDA210428, NDA218698, NDA219373, 24 ANDA |
| Active ingredients (FDA) | METOPROLOL |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Lopressor, Validus Pharmaceuticals LLC, effective January 26, 2026; 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 →