Does Carvedilol have a boxed warning?

No. None of the 120 FDA labels we found for this medicine has a boxed warning.

Is there a shortage of Carvedilol?

No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).

Has Carvedilol been recalled?

FDA enforcement reports list 17 recalls of products of this medicine; the newest started August 20, 2025 (Class II). A recall usually concerns specific lots, not every product.

Who makes Carvedilol?

38 companies list prescription products of Carvedilol in the FDA NDC Directory, including Bryant Ranch Prepack, A-S Medication Solutions and Proficient Rx LP.

Carvedilol (Coreg, Coreg CR): uses, warnings, recalls

Quick answers

What is Carvedilol used for?: The FDA-approved label (Coreg, Waylis Therapeutics LLC, July 31, 2026) says: “1. INDICATIONS AND USAGE COREG is an alpha-/beta-adrenergic blocking agent indicated for the treatment of: mild to severe chronic heart failure left ventricular dysfunction following myocardial infarction in clinically stable patients hypertension 1.1 Heart Failure COREG is indicated for the treatment of mild-to-severe chronic heart failure of ischemic or cardiomyopathic origin, usually in addition to diuretics, ACE …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Carvedilol have a boxed warning?: No. None of the 120 FDA labels we found for this medicine has a boxed warning.
Is there a shortage of Carvedilol?: No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Carvedilol been recalled?: FDA enforcement reports list 17 recalls of products of this medicine; the newest started August 20, 2025 (Class II). A recall usually concerns specific lots, not every product.
Who makes Carvedilol?: 38 companies list prescription products of Carvedilol in the FDA NDC Directory, including Bryant Ranch Prepack, A-S Medication Solutions and Proficient Rx LP.

What Carvedilol is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

1. INDICATIONS AND USAGE COREG is an alpha-/beta-adrenergic blocking agent indicated for the treatment of: mild to severe chronic heart failure left ventricular dysfunction following myocardial infarction in clinically stable patients hypertension 1.1 Heart Failure COREG is indicated for the treatment of mild-to-severe chronic heart failure of ischemic or cardiomyopathic origin, usually in addition to diuretics, ACE …

— FDA label: Coreg, Waylis Therapeutics LLC, effective July 31, 2026. Read the full label on DailyMed →

The FDA has 120 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.

Conditions named on the label

These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.

Heart failure High blood pressure

Related medical specialties

Cardiology

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.

0 of 120 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage forms	Tablet, film coated · Capsule, extended release
Route	Oral
Prescription products	206 in the FDA NDC Directory
Brand names	Coreg, Coreg CR

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.

NADAC per unit for Carvedilol, by strength and form
Strength and form	Generic or brand	Pharmacies pay
carvedilol 12.5 mg tablet, film coated	Generic	$0.0213 per tablet
carvedilol 25 mg tablet, film coated	Generic	$0.0323 per tablet
carvedilol 3.125 mg tablet, film coated	Generic	$0.0162 per tablet
carvedilol 6.25 mg tablet, film coated	Generic	$0.0176 per tablet
carvedilol phosphate 10 mg capsule, extended release	Generic	$6.79 per capsule
carvedilol phosphate 20 mg capsule, extended release	Generic	$6.71 per capsule
carvedilol phosphate 40 mg capsule, extended release	Generic	$6.57 per capsule
carvedilol phosphate 80 mg capsule, extended release	Generic	$6.00 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.

Bryant Ranch Prepack21 products
A-S Medication Solutions17 products
Proficient Rx LP12 products
NuCare Pharmaceuticals, Inc.10 products
Waylis Therapeutics LLC8 products
PD-Rx Pharmaceuticals, Inc.8 products
Golden State Medical Supply, Inc.8 products
Northwind Health Company, LLC7 products
Remedyrepack Inc.7 products
Direct_Rx5 products
Preferred Pharmaceuticals Inc.5 products
Aphena Pharma Solutions - Tennessee, LLC5 products
Coupler LLC5 products
Quallent Pharmaceuticals Health LLC4 products
Dr. Reddy's Laboratories Limited4 products
Zydus Pharmaceuticals USA Inc.4 products
Unichem Pharmaceuticals (USA), Inc.4 products
Teva Pharmaceuticals USA, Inc.4 products
Advagen Pharma Ltd4 products
Advagen Pharma Limited4 products
NCS HealthCare of KY, LLC dba Vangard Labs4 products
Cardinal Health 107, LLC4 products
Method Pharmaceuticals, LLC4 products
Zydus Lifesciences Limited4 products
Aurobindo Pharma Limited4 products
Major Pharmaceuticals4 products
BluePoint Laboratories4 products
Glenmark Pharmaceuticals Inc., USA4 products
Amneal Pharmaceuticals of New York LLC4 products
Amneal Pharmaceuticals NY LLC4 products
Sun Pharmaceutical Industries, Inc.4 products
AvKARE4 products
NorthStar RxLLC4 products
St. Mary's Medical Park Pharmacy2 products
QPharma, Inc.2 products
RedPharm Drug, Inc.2 products
American Health Packaging1 product
Redpharm Drug1 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.

Brand and biologic applications
Application	Sponsor	Approved	Later changes approved
NDA020297 COREG	Waylis Therap	September 14, 1995	26, latest July 26, 2023 2023: Labeling · 2017: Labeling · 2015: Labeling
NDA022012 COREG CR	Waylis Therap	October 20, 2006	13, latest July 26, 2023 2023: Labeling · 2017: Labeling · 2015: Labeling

Generic approvals (11)

ANDA076373Teva · September 5, 2007
ANDA076649Rising · September 5, 2007
ANDA077614Zydus Pharms USA Inc · September 5, 2007
ANDA078165Rubicon Research · September 5, 2007
ANDA078227Sandoz · September 5, 2007
ANDA078251Glenmark Pharms Ltd · September 5, 2007
ANDA078332Aurobindo Pharma · September 5, 2007
ANDA078384Regcon Holdings · September 5, 2007
ANDA078786Mlv · December 22, 2009
ANDA090132Sun Pharm Industries · October 25, 2017
ANDA204717Impax Labs Inc · May 7, 2018

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

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.

August 20, 2025 · Class II · Ongoing · D-0594-2025

CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm

Carvedilol Tablets USP, 12.5 mg, 100- Tablets, (10x10) cartons, Rx Only, Packaged and distributed by Major Pharmaceuticals, Indianapolis, IN, 46268, USA, NDC 0904-7307-61 — The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
August 7, 2025 · Class II · Ongoing · D-0577-2025

CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.

Carvedilol Tablets, USP, 3.125 mg, Packaged as: a)500-count bottle, NDC 68462-162-05; b) 100-count bottle, NDC 68462-162-01; Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Man — Glenmark Pharmaceuticals Inc., USA
August 7, 2025 · Class II · Ongoing · D-0579-2025

CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.

Carvedilol Tablets, USP, 25 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Manufactured for Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430. NDC 68 — Glenmark Pharmaceuticals Inc., USA
August 7, 2025 · Class II · Ongoing · D-0578-2025

CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.

Carvedilol Tablets, USP, 12.5 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Manufactured for Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430. NDC — Glenmark Pharmaceuticals Inc., USA
August 6, 2025 · Class II · Ongoing · D-0587-2025

CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm

Carvedilol Tablets, USP, 12.5 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India. Manufactured — Glenmark Pharmaceuticals Inc., USA
August 6, 2025 · Class II · Ongoing · D-0588-2025

CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm

Carvedilol Tablets, USP, 25 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India. Manufactured fo — Glenmark Pharmaceuticals Inc., USA
March 13, 2025 · Class II · Ongoing · D-0336-2025

CGMP Deviations

Carvedilol Tablets, USP 12.5 mg, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 0743 — Glenmark Pharmaceuticals Inc., USA
February 28, 2025 · Class II · Ongoing · D-0450-2025

CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit

Carvedilol Tablets USP 12.5 mg, 500-Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC: 68462-164-05 — Glenmark Pharmaceuticals Inc., USA
February 28, 2025 · Class II · Ongoing · D-0449-2025

CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit

Carvedilol Tablets USP 6.25 mg, a.)100-count bottle (NDC 68462-163-01), b.) 500-count bottle (NDC 68462-163-05) Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for: Glenmark Pharmaceuticals Inc., US — Glenmark Pharmaceuticals Inc., USA
February 28, 2025 · Class II · Ongoing · D-0451-2025

CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit

Carvedilol Tablets USP 25 mg, 500 -Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC 68462-165-05. — Glenmark Pharmaceuticals Inc., USA
February 28, 2025 · Class II · Ongoing · D-0448-2025

CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit

Carvedilol Tablets USP 3.125mg Tablets a.)100-count bottle (NDC 68462-162-01), b.) 500-count bottle (NDC 68462-162-05), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for: Glenmark Pharmaceuticals — Glenmark Pharmaceuticals Inc., USA
January 22, 2025 · Class II · Ongoing · D-0215-2025

CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.

Carvedilol Tablets, USP, 25 mg, Rx only, a)500 Tablets, NDC 68462-165-05; b) 100 Tablets, NDC 68462-165-01, Manufactured for Glenmark Pharmaceuticals, NJ. — Glenmark Pharmaceuticals Inc., USA
January 22, 2025 · Class II · Ongoing · D-0216-2025

CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.

Carvedilol Tablets, USP, 12.5 mg, Rx only, a)500 Tablets, NDC 68462-164-05; b) 100 Tablets, NDC 68462-164-01, Manufactured for Glenmark Pharmaceuticals, NJ. — Glenmark Pharmaceuticals Inc., USA
November 15, 2021 · Class III · Terminated · D-0263-2022

Failed Impurities/Degradation Specifications

Carvedilol Tablets, USP, 6.25 mg, 500 Tablets bottle, Rx Only, Distributed by: Aurobindo Pharma USA Inc., 279 Princeton-Hightstown Road, East Windsor, NJ, 08520, Made in India, NDC 65862-143-05 — Aurobindo Pharma USA Inc.
August 13, 2021 · Class II · Terminated · D-0753-2021

Presence of Foreign Tablets/Capsules; report of two Paroxetine tablets were found in the bottle

Carvedilol Tablets, USP 25 mg, 500 Tablets bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 0853, NDC 68382-095-05 — Zydus Pharmaceuticals (USA) Inc
April 25, 2019 · Class II · Terminated · D-1273-2019

Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg

Carvedilol Tablets, USP, 6.25 mg, 500 count bottles, Rx Only Manufactured by: Cadila Healthcare Ltd., India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ USA 08534 NDC 68382-093-05 — Zydus Pharmaceuticals USA Inc
April 22, 2019 · Class III · Terminated · D-1242-2019

Presence of Foreign Tablets/Capsules: Customer complaint for a small, solid, light yellow substance, identified as a fragmented tablet of another drug product, found mixed with tablets in a bottle of Carvedilol tablets 3.125mg.

Carvedilol Tablets, USP, 3.125 mg, 500-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd., India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; NDC 68382-092-05 — Zydus Pharmaceuticals USA 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)	200031, 200032, 200033, 212388, 212389, 212390, 686924, 686926, 860510, 860512 … (+6)
SPL set ID of the quoted label	07c619c6-4a0c-445e-94fa-664a54f68a39
FDA labels (SPL)	120
FDA applications	NDA020297, NDA022012, 11 ANDA
Active ingredients (FDA)	CARVEDILOL

Sources

FDA-approved label on DailyMed (National Library of Medicine) — Coreg, Waylis Therapeutics LLC, effective July 31, 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 →

Report an error → · Information for medicine makers

Carvedilol

Official FDA data, not advice

At a glance