Metoprolol Succinate Tablet, Film Coated, Extended Release
FDA Recall NDC 45963-709
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 45963-709). A significant event, classified as Class II, was initiated on Jan 29, 2026 by Actavis Pharma, Inc.. 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.
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
Class II Ongoing
Failed Dissolution Specifications
Jan 29, 2026
Mar 11, 2026
19,056 bottles
Recall Profile & Regulatory Data
Event ID
98348
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Teva Pharmaceuticals USA, Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Product Description
Metoprolol Succinate Extended-Release Tablets, 200 mg, 100 tablets bottles, Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054, NDC: 45963-678-11
Batch or Lot Expiration Information
Lot# : a) 0686H251, 0687H251, 10688H251, Exp.: 02/2027. .
Affected Packages Involved in this Recall
45963-709-11Product
45963-709-96Product
45963-676-11Product
45963-676-96Product
45963-677-11Product
45963-677-96Product
45963-678-11Product
Class II Ongoing
Failed Dissolution Specifications
Jan 29, 2026
Mar 11, 2026
18,780 bottles
Recall Profile & Regulatory Data
Event ID
98348
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Teva Pharmaceuticals USA, Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Product Description
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
Batch or Lot Expiration Information
Lot# : a) 0715J251, Exp.: 12/2026; 0716J251, Exp.: 01/2027; 0717J251, Exp.: 01/2027; b) 0715J252, Exp.: 12/2026; 0716J252, Exp.: 01/2027, 0717J252, Exp.: 01/2027.
Affected Packages Involved in this Recall
45963-709-11Product
45963-709-96Product
45963-676-11Product
45963-676-96Product
45963-677-11Product
45963-677-96Product
45963-678-11Product
Class II Ongoing
Failed Dissolution Specifications
Jan 29, 2026
Mar 11, 2026
7,448 bottles
Recall Profile & Regulatory Data
Event ID
98348
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Teva Pharmaceuticals USA, Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Product Description
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.
Batch or Lot Expiration Information
Lot# : a) 0718J251, 0729J251, 0730J251, Exp.: 12/2026; b) 0718J252, 0729J252, 0730J252, Exp.: 12/2026.
Affected Packages Involved in this Recall
45963-709-11Product
45963-709-96Product
45963-676-11Product
45963-676-96Product
45963-677-11Product
45963-677-96Product
45963-678-11Product
Class II Ongoing
Failed Dissolution Specifications
Jan 29, 2026
Mar 11, 2026
67,043 bottles
Recall Profile & Regulatory Data
Event ID
98348
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Teva Pharmaceuticals USA, Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Product Description
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
Batch or Lot Expiration Information
Lot# : a) 0486G251, 0487G251, 0488G251, Exp.: 01/2027; b) 0486G252, 0487G253, 0488G252, Exp.: 01/2027.
Affected Packages Involved in this Recall
45963-709-11Product
45963-709-96Product
45963-676-11Product
45963-676-96Product
45963-677-11Product
45963-677-96Product
45963-678-11Product
Class II Terminated
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Jan 26, 2022
Jan 03, 2024
1 unit
Recall Profile & Regulatory Data
Event ID
89450
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
CARDINAL HEALTHCARE
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide USA
Termination Date
Sep 29, 2024
Product Description
Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 1000 Tablets, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454. NDC: 45963-676-96
Batch or Lot Expiration Information
Batch# Batch 2447J211
Affected Packages Involved in this Recall
45963-709-11Product
45963-709-96Product
45963-676-11Product
45963-676-96Product
45963-677-11Product
45963-677-96Product
45963-678-11Product
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.
