Irbesartan recalls

Irbesartan products have been recalled 6 times, most recently on 3 Aug 2022. The recalling company is usually Lupin Pharmaceuticals. The most common reason is nitrosamine impurity.

Total recalls6since 2019

Last 12 months0reported

Class I00% of total

Ongoing0latest 3 Aug 2022

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 6 100%Class III 0 0%

Why irbesartan is recalled

Nitrosamine Impurity467%
Potency & Assay233%

Companies

Product types

Blood Pressure Medication6100%

By year

2022233%
2021350%
2019117%

All irbesartan recalls, newest first

6 total

Reported	Class	Recall	Company	Reason	Where
3 Aug 2022Drug	CLASS II	Irbesartan Tablets, USP, 150mg recalled by Jubilant CadistaIrbesartan	Jubilant Cadista Pharmaceuticals	Potency & Assay	Nationwide
3 Aug 2022Drug	CLASS II	Irbesartan Tablets, USP, 75 mg recalled by Jubilant CadistaIrbesartan	Jubilant Cadista Pharmaceuticals	Potency & Assay	Nationwide
10 Nov 2021Drug	CLASS II	Irbesartan Tablets USP, 75 mg a) recalled by Lupin PharmaceuticalsIrbesartan	Lupin Pharmaceuticals	Nitrosamine Impurity	Nationwide
10 Nov 2021Drug	CLASS II	Irbesartan Tablets USP, 300 mg a) recalled by Lupin PharmaceuticalsIrbesartan	Lupin Pharmaceuticals	Nitrosamine Impurity	Nationwide
10 Nov 2021Drug	CLASS II	Irbesartan Tablets USP, 150 mg a) recalled by Lupin PharmaceuticalsIrbesartan	Lupin Pharmaceuticals	Nitrosamine Impurity	Nationwide
6 Feb 2019Drug	CLASS II	Irbesartan Tablets 300 mg recalled by Prinston PharmaceuticalIrbesartan	Prinston Pharmaceutical	Nitrosamine Impurity	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.