Valsartan recalls

The FDA has published 88 recalls involving Valsartan since 2014. The latest was reported on 19 Aug 2026. Most were for potency & assay. 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 recalls88since 2014

Last 12 months1reported

Class I00% of total

Ongoing54latest 19 Aug 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 1Aug 0 0

Severity split

Class I 0 0%Class II 83 94%Class III 5 6%

Why valsartan is recalled

Companies

Prinston Pharmaceutical1011%
Aurobindo Pharma USA1011%
Teva Pharmaceuticals USA910%
Mylan Laboratories Limited, (Nashik FDF)910%
Avkare910%
Jubilant Cadista Pharmaceuticals56%
Mylan Pharmaceuticals56%
Rising Pharmaceuticals45%

Brands

By year

202611%
202111%
20191416%
20186877%
201445%

Ongoing valsartan recalls

54 active

Reported	Class	Recall	Company	Reason	Where
19 Aug 2026Drug	CLASS II	Diovan (valsartan) 160 mg recalled by Novartis PharmaceuticalsDiovan	Novartis Pharmaceuticals	Potency & Assay	Nationwide
27 Mar 2019Drug	CLASS II	Valsartan Tablets 160 mg recalled by Rising Pharmaceuticals	Rising Pharmaceuticals	Nitrosamine Impurity	Nationwide
27 Mar 2019Drug	CLASS II	Valsartan Tablets USP 80 mg recalled by Aurobindo Pharma USAValsartan	Aurobindo Pharma USA	Nitrosamine Impurity	Nationwide
27 Mar 2019Drug	CLASS II	Valsartan Tablets USP 320 mg recalled by Aurobindo Pharma USAValsartan	Aurobindo Pharma USA	Nitrosamine Impurity	Nationwide
27 Mar 2019Drug	CLASS II	Valsartan Tablets 80 mg recalled by Rising Pharmaceuticals	Rising Pharmaceuticals	Nitrosamine Impurity	Nationwide
27 Mar 2019Drug	CLASS II	Valsartan Tablets USP 160 mg recalled by Aurobindo Pharma USAValsartan	Aurobindo Pharma USA	Nitrosamine Impurity	Nationwide

All valsartan recalls, newest first

88 total

Reported	Class	Recall	Company	Reason	Where
19 Aug 2026Drug	CLASS II	Diovan (valsartan) 160 mg recalled by Novartis PharmaceuticalsDiovan	Novartis Pharmaceuticals	Potency & Assay	Nationwide
2 Jun 2021Drug	CLASS II	Valsartan Tablets recalled by Cardinal HealthValsartan	Cardinal Health	Manufacturing (CGMP) Deviations	FL, GA, SC
27 Mar 2019Drug	CLASS II	Valsartan Tablets 160 mg recalled by Rising Pharmaceuticals	Rising Pharmaceuticals	Nitrosamine Impurity	Nationwide
27 Mar 2019Drug	CLASS II	Valsartan Tablets USP 80 mg recalled by Aurobindo Pharma USAValsartan	Aurobindo Pharma USA	Nitrosamine Impurity	Nationwide
27 Mar 2019Drug	CLASS II	Valsartan Tablets USP 320 mg recalled by Aurobindo Pharma USAValsartan	Aurobindo Pharma USA	Nitrosamine Impurity	Nationwide
27 Mar 2019Drug	CLASS II	Valsartan Tablets 80 mg recalled by Rising Pharmaceuticals	Rising Pharmaceuticals	Nitrosamine Impurity	Nationwide
27 Mar 2019Drug	CLASS II	Valsartan Tablets USP 160 mg recalled by Aurobindo Pharma USAValsartan	Aurobindo Pharma USA	Nitrosamine Impurity	Nationwide
27 Mar 2019Drug	CLASS II	Valsartan Tablets USP 40 mg recalled by Aurobindo Pharma USAValsartan	Aurobindo Pharma USA	Nitrosamine Impurity	Nationwide
27 Mar 2019Drug	CLASS II	Valsartan Tablets 320 mg recalled by Rising Pharmaceuticals	Rising Pharmaceuticals	Nitrosamine Impurity	Nationwide
27 Mar 2019Drug	CLASS II	Valsartan Tablets 40 mg USP, Rx, Only recalled by Rising Pharmaceuticals	Rising Pharmaceuticals	Nitrosamine Impurity	Nationwide
23 Jan 2019Drug	CLASS II	Valsartan and Hydrochlorothiazide tablets USP 80 mg/12.5 mg recalledValsartan And Hydrochlorothiazide	Aurobindo Pharma USA	Nitrosamine Impurity	Nationwide
23 Jan 2019Drug	CLASS II	Valsartan and Hydrochlorothiazide tablets USP 320mg/12.5 mg recalledValsartan And Hydrochlorothiazide	Aurobindo Pharma USA	Nitrosamine Impurity	Nationwide
23 Jan 2019Drug	CLASS II	Valsartan and Hydrochlorothiazide tablets USP 320 mg/25 mg recalledValsartan And Hydrochlorothiazide	Aurobindo Pharma USA	Nitrosamine Impurity	Nationwide
23 Jan 2019Drug	CLASS II	Valsartan and Hydrochlorothiazide tablets USP 160mg/12.5 mg recalledValsartan And Hydrochlorothiazide	Aurobindo Pharma USA	Nitrosamine Impurity	Nationwide
23 Jan 2019Drug	CLASS II	Valsartan and Hydrochlorothiazide tablets USP 160 mg/25 mg recalledValsartan And Hydrochlorothiazide	Aurobindo Pharma USA	Nitrosamine Impurity	Nationwide
23 Jan 2019Drug	CLASS II	Valsartan tablets USP 320 mg recalled by Aurobindo Pharma USAValsartan	Aurobindo Pharma USA	Nitrosamine Impurity	Nationwide
19 Dec 2018Drug	CLASS II	Valsartan Tablets, USP, 80 mg recalled by Mylan Pharmaceuticals	Mylan Pharmaceuticals	Nitrosamine Impurity	Nationwide
19 Dec 2018Drug	CLASS II	Valsartan Tablets, USP 40 mg recalled by Mylan Laboratories Limited	Mylan Laboratories Limited, (Nashik FDF)	Nitrosamine Impurity	Nationwide
19 Dec 2018Drug	CLASS II	Valsartan and Hydrochlorothiazide Tablets, USP 320/12.5 mg recalledValsartan And Hydrochlorothiazide	Mylan Laboratories Limited, (Nashik FDF)	Nitrosamine Impurity	Nationwide
19 Dec 2018Drug	CLASS II	Valsartan and Hydrochlorothiazide Tablets, USP, 320 mg/25 mg, (a) recalledValsartan And Hydrochlorothiazide	Mylan Pharmaceuticals	Nitrosamine Impurity	Nationwide
19 Dec 2018Drug	CLASS II	Valsartan Tablets, USP, 160 mg recalled by Mylan Pharmaceuticals	Mylan Pharmaceuticals	Nitrosamine Impurity	Nationwide
19 Dec 2018Drug	CLASS II	Valsartan Tablets, USP, 40 mg recalled by Mylan Pharmaceuticals	Mylan Pharmaceuticals	Nitrosamine Impurity	Nationwide
19 Dec 2018Drug	CLASS II	Valsartan and Hydrochlorothiazide Tablets, USP 80/12.5 mg recalledValsartan And Hydrochlorothiazide	Mylan Laboratories Limited, (Nashik FDF)	Nitrosamine Impurity	Nationwide
19 Dec 2018Drug	CLASS II	Valsartan Tablets, USP 160 mg recalled by Mylan Laboratories Limited	Mylan Laboratories Limited, (Nashik FDF)	Nitrosamine Impurity	Nationwide
19 Dec 2018Drug	CLASS II	Valsartan Tablets, USP, 320 mg recalled by Mylan Pharmaceuticals	Mylan Pharmaceuticals	Nitrosamine Impurity	Nationwide
19 Dec 2018Drug	CLASS II	Valsartan Tablets, USP 80 mg recalled by Mylan Laboratories Limited	Mylan Laboratories Limited, (Nashik FDF)	Nitrosamine Impurity	Nationwide
19 Dec 2018Drug	CLASS II	Valsartan Tablets, USP 320 mg recalled by Mylan Laboratories Limited	Mylan Laboratories Limited, (Nashik FDF)	Nitrosamine Impurity	Nationwide
19 Dec 2018Drug	CLASS II	Valsartan and Hydrochlorothiazide Tablets, USP 160/12.5 mg recalledValsartan And Hydrochlorothiazide	Mylan Laboratories Limited, (Nashik FDF)	Nitrosamine Impurity	Nationwide
19 Dec 2018Drug	CLASS II	Valsartan and Hydrochlorothiazide Tablets, USP 160/25 mg recalledValsartan And Hydrochlorothiazide	Mylan Laboratories Limited, (Nashik FDF)	Nitrosamine Impurity	Nationwide
19 Dec 2018Drug	CLASS II	Valsartan and Hydrochlorothiazide Tablets, USP 320/25 mg recalledValsartan And Hydrochlorothiazide	Mylan Laboratories Limited, (Nashik FDF)	Nitrosamine Impurity	Nationwide

Should you stop taking Valsartan?

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.