Metoprolol Succinate

Metoprolol Succinate recalls: 9 FDA reports

Recalls involving Metoprolol Succinate. What was wrong with each batch, and how the FDA graded the risk.

9Reports
0Class I
5Ongoing
2026-03-11Most recent

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

ClassWhat the FDA is saying
Class IThere is a reasonable probability that using this will cause serious harm or death.
Class IIIt may cause temporary or reversible harm. Serious harm is unlikely.
Class IIIIt breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

ClassReports
Class II9

By year reported

YearReports
20142
20181
20241
20251
20264
Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

Metoprolol Succinate Extended-Release Tablets, 50 mg, 100 tablets bottles (NDC: 45963-676-11) and 1,000 tablet

D-0355-2026  ·  Class II  ·  reported 2026-03-11  ·  Ongoing

Why it was recalled
Failed Dissolution Specifications
Product
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
Where it went
Nationwide
How much
67,043 bottles

Metoprolol Succinate Extended-Release Tablets, 25 mg, 100 tablets bottles (NDC: 45963-709-11) and 1,000 tablet

D-0354-2026  ·  Class II  ·  reported 2026-03-11  ·  Ongoing

Why it was recalled
Failed Dissolution Specifications
Product
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
Where it went
Nationwide
How much
18,780 bottles

Metoprolol Succinate Extended-Release Tablets, 200 mg, 100 tablets bottles, Rx Only, Teva Pharmaceuticals, Par

D-0357-2026  ·  Class II  ·  reported 2026-03-11  ·  Ongoing

Why it was recalled
Failed Dissolution Specifications
Product
Metoprolol Succinate Extended-Release Tablets, 200 mg, 100 tablets bottles, Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054, NDC: 45963-678-11
Where it went
Nationwide
How much
19,056 bottles

Metoprolol Succinate Extended-Release Tablets, Rx Only, 100 mg, 100 tablets bottles (NDC: 45963-677-11) and 1,

D-0356-2026  ·  Class II  ·  reported 2026-03-11  ·  Ongoing

Why it was recalled
Failed Dissolution Specifications
Product
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.
Where it went
Nationwide
How much
7,448 bottles

Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Packaged in a) 100-count bottle, NDC 70010-780-01;

D-0510-2025  ·  Class II  ·  reported 2025-07-09  ·  Ongoing

Why it was recalled
Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH) long-term.
Product
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, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA 20151,
Where it went
Nationwide in the USA.
How much
27,648 100-count Bottles; 5,376 500-count Bottles

Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 1000 Tablets, Rx Only, Teva Pharmaceuticals USA, In

D-0191-2024  ·  Class II  ·  reported 2024-01-03  ·  Terminated

Why it was recalled
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Product
Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 1000 Tablets, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454. NDC: 45963-676-96
Where it went
Nationwide USA
How much
1 unit

Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100 Tablets bottle, Rx only, Manufactured by: Dr.

D-0727-2018  ·  Class II  ·  reported 2018-05-16  ·  Terminated

Why it was recalled
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.
Product
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
Where it went
Nationwide
How much
8160 bottles

Dr. Reddy's Metoprolol Succinate Extended Release Tablets, USP 25 mg. 100-count bottle, Rx only, Manufactured

D-1381-2014  ·  Class II  ·  reported 2014-06-18  ·  Terminated

Why it was recalled
Failed Dissolution Specifications: Failure of dissolution test observed at the 18 month time point.
Product
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
Where it went
Nationwide
How much
13560 bottles

Dr. Reddy's Metoprolol Succinate Extended-Release Tablets USP, 50 mg 100 tablets Rx Only Mfd. By: Dr. Reddy's

D-1080-2014  ·  Class II  ·  reported 2014-02-12  ·  Terminated

Why it was recalled
Failed Dissolution Specification; 12-Month stability interval.
Product
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
Where it went
LA, MI, MO, MS & OH
How much
8,592 bottles
Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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