Irbesartan And Hydrochlorothiazide recalls

Irbesartan And Hydrochlorothiazide products have been recalled 6 times, most recently on 6 Feb 2019. The recalling company is usually Prinston Pharmaceutical. The most common reason is nitrosamine impurity.

Total recalls6since 2015

Last 12 months0reported

Class I00% of total

Ongoing0latest 6 Feb 2019

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 4 67%Class III 2 33%

Why irbesartan and hydrochlorothiazide is recalled

Nitrosamine Impurity467%
Other Reasons233%

Companies

Product types

Blood Pressure Medication6100%

By year

2019467%
2016117%
2015117%

All irbesartan and hydrochlorothiazide recalls, newest first

6 total

Reported	Class	Recall	Company	Reason	Where
6 Feb 2019Drug	CLASS II	Irbesartan and HydrochlorothiazideTablets, USP 150/12.5 mg recalledIrbesartan And Hydrochlorothiazide	Prinston Pharmaceutical	Nitrosamine Impurity	Nationwide
6 Feb 2019Drug	CLASS II	Irbesartan and Hydrochlorothiazide Tablets, USP 150/12.5 mg Rx Only recalledIrbesartan And Hydrochlorothiazide	Prinston Pharmaceutical	Nitrosamine Impurity	Nationwide
6 Feb 2019Drug	CLASS II	Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg recalledIrbesartan And Hydrochlorothiazide	Prinston Pharmaceutical	Nitrosamine Impurity	Nationwide
6 Feb 2019Drug	CLASS II	Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg recalledIrbesartan And Hydrochlorothiazide	Prinston Pharmaceutical	Nitrosamine Impurity	Nationwide
29 Jun 2016Drug	CLASS III	Irbesartan and Hydrochlorothiazide Tablets, USP, 300/12.5 mg recalledIrbesartan And Hydrochlorothiazide	Prinston Pharmaceutical	Other	Nationwide
23 Dec 2015Drug	CLASS III	Irbesartan and Hydrochlorothiazide tablets USP 150 mg/ 5 mg recalledIrbesartan And Hydrochlorothiazide	Teva Pharmaceutical Industries	Other	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.