METOPROLOL SUCCINATE

Generic: METOPROLOL SUCCINATE

Actavis PharmaManufacturer
ORALRoute
METOPROLOL SUCCINATEActive Substance
2016-11-25Original Approval

METOPROLOL SUCCINATE is FDA application ANDA204161, sponsored by ACTAVIS ELIZABETH. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class II2023-01-05
Metoprolol Succinate Extended-Release Tablets, USP 25 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Labor

Failed Dissolution Specification

Class II2023-01-05
Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Labora

Failed Dissolution Specification

Class II2013-12-13
Dr. Reddy's Metoprolol Succinate Extended-Release Tablets USP, 50 mg 100 tablets Rx Only Mfd. By: Dr. Reddy's Laboratori

Failed Dissolution Specification; 12-Month stability interval.

Class II2014-05-23
Dr. Reddy's Metoprolol Succinate Extended Release Tablets, USP 25 mg. 100-count bottle, Rx only, Manufactured By: Dr. R

Failed Dissolution Specifications: Failure of dissolution test observed at the 18 month time point.

Class II2021-12-20
Metoprolol Succinate Extended-Release Tablets, USP 50 mg, 500-count bottle, Rx Only, Manufactured by: Alkem Laboratories

Failed Dissolution Specifications

Class II2018-04-23
Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100 Tablets bottle, Rx only, Manufactured by: Dr. Reddy's La

Presence of Foreign Tablets/Capsules: One foreign tablet identified as Clopidogrel 75 mg was found i

Class II2022-01-26
Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 1000 Tablets, Rx Only, Teva Pharmaceuticals USA, Inc., North

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage condi

Class II2023-01-05
Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 500 Tablets per bottle, Manufactured by: Alkem Labor

Failed Dissolution Specification

Class II2025-06-24
Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Packaged in a) 100-count bottle, NDC 70010-780-01; b) 500-cou

Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the sta

Class II2026-01-29
Metoprolol Succinate Extended-Release Tablets, 50 mg, 100 tablets bottles (NDC: 45963-676-11) and 1,000 tablets bottles

Failed Dissolution Specifications

Top Reported Reactions

1
FATIGUE
4,821 reports
2
DIARRHOEA
3,932 reports
3
DYSPNOEA
3,752 reports
4
NAUSEA
3,715 reports
5
DIZZINESS
3,109 reports
6
OFF LABEL USE
3,001 reports
7
DRUG INEFFECTIVE
2,994 reports
8
HEADACHE
2,831 reports
9
DEATH
2,587 reports
10
ASTHENIA
2,377 reports