Irbesartan recalls

The FDA has published 16 recalls involving Irbesartan since 2015. The latest was reported on 19 Feb 2025. Most were for nitrosamine impurity. Prinston Pharmaceutical has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls16since 2015

Last 12 months0reported

Class I00% of total

Ongoing1latest 19 Feb 2025

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 1 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 14 88%Class III 2 13%

Why irbesartan is recalled

Companies

Brands

Irbesartan And Hydrochlorothiazide638%
Irbesartan638%

By year

202516%
2022213%
2021319%
2019531%
2018319%
201616%
201516%

Ongoing irbesartan recalls

1 active

Reported	Class	Recall	Company	Reason	Where
19 Feb 2025Drug	CLASS II	Irbesartan Tablets USP, 300 mg Dose recalled by AvKARE	AvKARE	Potency & Assay	Nationwide

All irbesartan recalls, newest first

16 total

Reported	Class	Recall	Company	Reason	Where
19 Feb 2025Drug	CLASS II	Irbesartan Tablets USP, 300 mg Dose recalled by AvKARE	AvKARE	Potency & Assay	Nationwide
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 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 Tablets 300 mg recalled by Prinston PharmaceuticalIrbesartan	Prinston Pharmaceutical	Nitrosamine Impurity	Nationwide

Should you stop taking Irbesartan?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.