HYDROCHLOROTHIAZIDE

Generic: HYDROCHLOROTHIAZIDE

Exelan Pharmaceuticals Inc.Manufacturer

ORALRoute

HYDROCHLOROTHIAZIDEActive Substance

2008-08-15Original Approval

HYDROCHLOROTHIAZIDE is FDA application ANDA040907, sponsored by UNICHEM. 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 II2026-01-21

Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, Manufactured by: UN

cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.

Class II2018-12-04

Valsartan and Hydrochlorothiazide Tablets, USP 320/25 mg, (a) 90-count bottle (NDC 0378-6325-77), (b) 500-count bottles

GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylam

Class II2019-01-18

Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co.,

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in

Class II2018-12-04

Valsartan and Hydrochlorothiazide Tablets, USP 160/25 mg, (a) 90-count bottle (NDC 0378-6323-77), (b) 500-count bottles

GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylam

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 II2018-12-04

Valsartan and Hydrochlorothiazide Tablets, USP 160/12.5 mg, (a) 90-count bottle (NDC 0378-6322-77), (b) 500-count bottle

GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylam

Class II2018-07-13

Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/25 MG Tablets, 90-count bottle, Rx Only, Manufactured

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

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 I2018-08-21

Hydrochlorothiazide Tablets USP, 12.5 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham,

Product Mix-Up: customer complaint that a sealed bottle labeled as Hydrochlorothiazide Tablets USP 1

HYDROCHLOROTHIAZIDE

Recalls

Top Reported Reactions