AMLODIPINE BESYLATE

Generic: AMLODIPINE BESYLATE

Ascend LaboratoriesManufacturer
ORALRoute
AMLODIPINE BESYLATEActive Substance
2009-05-04Original Approval

AMLODIPINE BESYLATE is FDA application ANDA078925, sponsored by ALKEM. 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 II2025-07-02
Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg, 100 Capsules bottle, Rx Only, Manufactured for: Lupin Pharmaceu

Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 inst

Class III2015-05-06
Amlodipine besylate and Atorvastatin calcium tablets, 5mg/10mg, packaged in a)30-count bottle (NDC 43598-322-30), b) 90-

Subpotent drug

Class III2018-10-03
Amlodipine Besylate USP 10 mg Tablets, 1000-count bottles, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manuf

Subpotent Drug: One lot of product does not meet the product specification for Assay test at 3 month

Class III2017-05-05
AMLODIPINE BESYLATE TABLET, USP, 10 mg, 1000 count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 4

PRESENCE OF FOREIGN TABLETS/CAPSULES: A 2.5 mg Amlodipine Besylate tablet was found co-mingled with

Class III2023-06-27
Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Balti

Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stabi

Class III2015-08-13
Amlodipine besylate and Atorvastatin calcium Tablets, 10 mg/80 mg, 30 Count Bottles, Rx Only. Manufactured by Dr. Reddy'

Subpotent Drug: Subpotent atorvastatin.

Class II2012-04-09
Dr. Reddy's Amlodipine Besylate and Benazepril Hydrochloride 5 mg*/20 mg, 500 Capsules, Rx only, Mfd. By: Dr. Reddy's L

Adulterated Presence of Foreign Tablets: Dr. Reddy's Laboratories has received complaints of mislabe

Class III2015-08-13
Amlodipine besylate and Atorvastatin calcium Tablets,2.5 mg/40 mg, 30 Count Bottles, Rx Only. Manufactured by Dr. Reddy'

Subpotent Drug: Subpotent atorvastatin.

Class III2015-08-13
Amlodipine besylate and Atorvastatin calcium Tablets, 10 mg/20 mg, Packaged in a) 30 Count Bottles (NDC: 43598-318-30) a

Subpotent Drug: Subpotent atorvastatin.

Class III2015-05-06
Amlodipine besylate and Atorvastatin calcium tablets, 10mg/10mg, packaged in a)30-count bottle (NDC 43598-321-30), b) 90

Subpotent drug

Top Reported Reactions

1
FATIGUE
5,457 reports
2
DIARRHOEA
4,185 reports
3
DYSPNOEA
3,951 reports
4
NAUSEA
3,884 reports
5
DRUG INEFFECTIVE
3,659 reports
6
PAIN
3,658 reports
7
HEADACHE
3,314 reports
8
OFF LABEL USE
3,259 reports
9
DIZZINESS
2,996 reports
10
PNEUMONIA
2,987 reports