LISINOPRIL AND HYDROCHLOROTHIAZIDE

Generic: LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS

Exelan PharmaceuticalsManufacturer
ORALRoute
LISINOPRILActive Substance
2017-05-23Original Approval

LISINOPRIL AND HYDROCHLOROTHIAZIDE is FDA application ANDA204058, sponsored by INVAGEN PHARMS. 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 III2016-04-04
Lisinopril & Hydrochlorothiazide Tables, USP 20mg/12.5mg, packaged in a)100-count bottles and b) 5000-count bottles, Rx

CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose interm

Class II2025-06-20
Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, 100-count bottles, Rx only, Mfg for: Lupin Pharmaceuticals,

Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle

Class II2019-07-19
Lisinopril and Hydrochlorothiazide Tablets USP, 20 mg/12.5 mg, 500-count bottle, Rx only, Manufactured for: Lupin Pharma

Presence of Foreign Tablets/Capsules: Product complaint received of one Fenofibrate tablet 145mg obs

Class II2022-01-26
Lisinopril and Hydrochlorothiazide Tablets USP, 10mg/12.5mg, Rx only, 100 Tablets per bottles, Manufactured for: Lupin P

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

Class II2019-07-17
Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg, 100 tablet bottle, Rx only, Manufactured by for: Lupin Ph

Presence of Foreign Substance; Product complaints received related to brownish/blackish stains on th

Top Reported Reactions

1
NAUSEA
547 reports
2
FATIGUE
538 reports
3
DIARRHOEA
487 reports
4
DRUG INEFFECTIVE
480 reports
5
DIZZINESS
393 reports
6
PAIN
384 reports
7
HEADACHE
336 reports
8
DYSPNOEA
319 reports
9
COUGH
291 reports
10
VOMITING
282 reports