Irbesartan recalls
The FDA has published 20 recalls involving Irbesartan since 2014. 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 recalls 20 since 2014
Last 12 months 0 reported
Class I 0 0% of total
Ongoing 1 latest 19 Feb 2025
Recalls per month, last 24 months click a bar for that month Severity split
0 0%18 90%2 10%
Why irbesartan is recalled
Ongoing irbesartan recalls 1 active
All irbesartan recalls, newest first 20 total Reported Class Recall Company Reason Where 19 Feb 2025 Drug CLASS II Irbesartan Tablets USP, 300 mg Dose recalled by AvKARE AvKARE Potency & Assay Nationwide 3 Aug 2022 Drug CLASS II Irbesartan Tablets, USP, 150mg recalled by Jubilant Cadista Irbesartan Jubilant Cadista Pharmaceuticals Potency & Assay Nationwide 3 Aug 2022 Drug CLASS II Irbesartan Tablets, USP, 75 mg recalled by Jubilant Cadista Irbesartan Jubilant Cadista Pharmaceuticals Potency & Assay Nationwide 10 Nov 2021 Drug CLASS II Irbesartan and Hydrochlorothiazide Tablets USP, 150/12.5 mg a) recalled Lupin Pharmaceuticals Nitrosamine Impurity Nationwide 10 Nov 2021 Drug CLASS II Irbesartan Tablets USP, 75 mg a) recalled by Lupin Pharmaceuticals Irbesartan Lupin Pharmaceuticals Nitrosamine Impurity Nationwide 10 Nov 2021 Drug CLASS II Irbesartan Tablets USP, 300 mg a) recalled by Lupin Pharmaceuticals Irbesartan Lupin Pharmaceuticals Nitrosamine Impurity Nationwide 10 Nov 2021 Drug CLASS II Irbesartan Tablets USP, 150 mg a) recalled by Lupin Pharmaceuticals Irbesartan Lupin Pharmaceuticals Nitrosamine Impurity Nationwide 10 Nov 2021 Drug CLASS II Irbesartan and Hydrochlorothiazide Tablets USP, 300/12.5 mg a) recalled Lupin Pharmaceuticals Nitrosamine Impurity Nationwide 6 Feb 2019 Drug CLASS II Irbesartan and HydrochlorothiazideTablets, USP 150/12.5 mg recalled Irbesartan And Hydrochlorothiazide Prinston Pharmaceutical Nitrosamine Impurity Nationwide 6 Feb 2019 Drug CLASS II Irbesartan and Hydrochlorothiazide Tablets, USP 150/12.5 mg Rx Only recalled Irbesartan And Hydrochlorothiazide Prinston Pharmaceutical Nitrosamine Impurity Nationwide 6 Feb 2019 Drug CLASS II Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg recalled Irbesartan And Hydrochlorothiazide Prinston Pharmaceutical Nitrosamine Impurity Nationwide 6 Feb 2019 Drug CLASS II Irbesartan Tablets 300 mg recalled by Prinston Pharmaceutical Irbesartan Prinston Pharmaceutical Nitrosamine Impurity Nationwide 6 Feb 2019 Drug CLASS II Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg recalled Irbesartan And Hydrochlorothiazide Prinston Pharmaceutical Nitrosamine Impurity Nationwide 28 Nov 2018 Drug CLASS II Irbesartan Tablets, USP 75 mg recalled by Golden State Medical Supply Golden State Medical Supply Nitrosamine Impurity Nationwide 28 Nov 2018 Drug CLASS II Irbesartan Tablets, USP 150 mg (a) bottle recalled Golden State Medical Supply Nitrosamine Impurity Nationwide 28 Nov 2018 Drug CLASS II Irbesartan Tablets, USP 300 mg (a) bottle recalled Golden State Medical Supply Nitrosamine Impurity Nationwide 29 Jun 2016 Drug CLASS III Irbesartan and Hydrochlorothiazide Tablets, USP, 300/12.5 mg recalled Irbesartan And Hydrochlorothiazide Prinston Pharmaceutical Other Nationwide 23 Dec 2015 Drug CLASS III Irbesartan and Hydrochlorothiazide tablets USP 150 mg/ 12.5 mg recalled Irbesartan And Hydrochlorothiazide Teva Pharmaceutical Industries Other Nationwide 29 Jan 2014 Drug CLASS II Irbesartan, Tablet, 150 mg recalled by Aidapak Services Aidapak Services Labeling Errors 4 states 22 Jan 2014 Drug CLASS II Irbesartan, Tablet, 150 mg recalled by Aidapak Services Aidapak Services Labeling Errors 4 states
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.