AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE

Generic: AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE

Dr.Reddy's Laboratories LimitedManufacturer
ORALRoute
AMLODIPINE BESYLATEActive Substance
2010-04-15Original Approval

AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE is FDA application ANDA077183, sponsored by DR REDDYS LABS INC. 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 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

Top Reported Reactions

1
FATIGUE
45 reports
2
DIARRHOEA
44 reports
3
DRUG INEFFECTIVE
41 reports
4
CHRONIC KIDNEY DISEASE
35 reports
5
NAUSEA
34 reports
6
RENAL FAILURE
33 reports
7
COMPLETED SUICIDE
30 reports
8
DYSPNOEA
29 reports
9
HEADACHE
29 reports
10
ACUTE KIDNEY INJURY
26 reports