Metoprolol Succinate Tablet, Film Coated, Extended Release
FDA Recall NDC 67877-593

FDA Enforcement Report: View Recall Date, Reasons, and Safety Status

Active & Historical Enforcement Reports

The FDA has identified 5 recorded enforcement report(s) associated with Metoprolol Succinate (NDC 67877-593). A significant event, classified as Class II, was initiated on Apr 27, 2026 by Ascend Laboratories, Llc. The reported reason for this action was: "Failed Dissolution Specifications"

This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.

Reported Recall Events

D-0547-2026ONGOINGD-0169-2023TERMINATEDD-0170-2023TERMINATEDD-0171-2023TERMINATEDD-0393-2022TERMINATED

April 2026 Class II Recall: Failed Dissolution Specifications

Recall Number
D-0547-2026
Class II Ongoing
Reason for Recall
Failed Dissolution Specifications
Initiated
Apr 27, 2026
Reported
May 20, 2026
Quantity
17,304 100-count bottles

Recall Profile & Regulatory Data

Event ID
98821
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Ascend Laboratories, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide
Product Description
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 67877-590-01.
Batch or Lot Expiration Information
Lot# 25140859; Exp. Date: Jan 2027
Affected Packages Involved in this Recall
67877-590-30Product
67877-590-60Product
67877-590-01Product
67877-590-05Product
67877-590-10Product
67877-591-30Product
67877-591-60Product
67877-591-01Product
67877-591-05Product
67877-591-10Product
67877-592-30Product
67877-592-60Product
67877-592-01Product
67877-592-05Product
67877-592-10Product
67877-593-30Product
67877-593-60Product
67877-593-01Product
67877-593-05Product
67877-593-10Product

January 2023 Class II Recall: Failed Dissolution Specification

Recall Number
D-0169-2023
Class II Terminated
Reason for Recall
Failed Dissolution Specification
Initiated
Jan 05, 2023
Reported
Feb 01, 2023
Quantity
49,632 bottles

Recall Profile & Regulatory Data

Event ID
91442
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Ascend Laboratories, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Aug 15, 2024
Product Description
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, NDC 67877-590-01.
Batch or Lot Expiration Information
Lot# s: 21143094, 21143095, 21143119, 21143121, 21142389, Exp 03/31/2023.
Affected Packages Involved in this Recall
67877-590-30Product
67877-590-60Product
67877-590-01Product
67877-590-05Product
67877-590-10Product
67877-591-30Product
67877-591-60Product
67877-591-01Product
67877-591-05Product
67877-591-10Product
67877-592-30Product
67877-592-60Product
67877-592-01Product
67877-592-05Product
67877-592-10Product
67877-593-30Product
67877-593-60Product
67877-593-01Product
67877-593-05Product
67877-593-10Product

January 2023 Class II Recall: Failed Dissolution Specification

Recall Number
D-0170-2023
Class II Terminated
Reason for Recall
Failed Dissolution Specification
Initiated
Jan 05, 2023
Reported
Feb 01, 2023
Quantity
6,336 bottles

Recall Profile & Regulatory Data

Event ID
91442
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Ascend Laboratories, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Aug 15, 2024
Product Description
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, NDC 67877-591-01.
Batch or Lot Expiration Information
Lot# : 21142633, Exp 03/31/2023
Affected Packages Involved in this Recall
67877-590-30Product
67877-590-60Product
67877-590-01Product
67877-590-05Product
67877-590-10Product
67877-591-30Product
67877-591-60Product
67877-591-01Product
67877-591-05Product
67877-591-10Product
67877-592-30Product
67877-592-60Product
67877-592-01Product
67877-592-05Product
67877-592-10Product
67877-593-30Product
67877-593-60Product
67877-593-01Product
67877-593-05Product
67877-593-10Product

January 2023 Class II Recall: Failed Dissolution Specification

Recall Number
D-0171-2023
Class II Terminated
Reason for Recall
Failed Dissolution Specification
Initiated
Jan 05, 2023
Reported
Feb 01, 2023
Quantity
2628 bottles

Recall Profile & Regulatory Data

Event ID
91442
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Ascend Laboratories, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Aug 15, 2024
Product Description
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, NDC 67877-591-05.
Batch or Lot Expiration Information
Lot# : 21141321, 21141322, Exp 01/31/2023.
Affected Packages Involved in this Recall
67877-590-30Product
67877-590-60Product
67877-590-01Product
67877-590-05Product
67877-590-10Product
67877-591-30Product
67877-591-60Product
67877-591-01Product
67877-591-05Product
67877-591-10Product
67877-592-30Product
67877-592-60Product
67877-592-01Product
67877-592-05Product
67877-592-10Product
67877-593-30Product
67877-593-60Product
67877-593-01Product
67877-593-05Product
67877-593-10Product

January 2022 Class II Recall: Failed Dissolution Specifications.

Recall Number
D-0393-2022
Class II Terminated
Reason for Recall
Failed Dissolution Specifications.
Initiated
Jan 12, 2022
Reported
Feb 02, 2022
Quantity
9216 bottles

Recall Profile & Regulatory Data

Event ID
89411
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Ascend Laboratories, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
May 31, 2023
Product Description
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, NDC 67877-590-01.
Batch or Lot Expiration Information
Lot# : 21143093, Exp. March 2023
Affected Packages Involved in this Recall
67877-590-30Product
67877-590-60Product
67877-590-01Product
67877-590-05Product
67877-590-10Product
67877-591-30Product
67877-591-60Product
67877-591-01Product
67877-591-05Product
67877-591-10Product
67877-592-30Product
67877-592-60Product
67877-592-01Product
67877-592-05Product
67877-592-10Product
67877-593-30Product
67877-593-60Product
67877-593-01Product
67877-593-05Product
67877-593-10Product

About FDA Recall Enforcement Reports

FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.

If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.