Valsartan recalls

Valsartan products have been recalled 27 times, most recently on 2 Jun 2021. The recalling company is usually Aurobindo Pharma USA. The most common reason is nitrosamine impurity.

Total recalls27since 2018

Last 12 months0reported

Class I00% of total

Ongoing17latest 2 Jun 2021

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 24 89%Class III 3 11%

Why valsartan is recalled

Companies

Aurobindo Pharma USA519%
Prinston Pharmaceutical519%
Hetero Labs Limited Unit V415%
Mylan Pharmaceuticals415%
Mylan Laboratories Limited, (Nashik FDF)415%
Jubilant Cadista Pharmaceuticals311%
Cardinal Health14%
Bryant Ranch Prepack14%

Product types

Blood Pressure Medication27100%

By year

202114%
2019519%
20182178%

Ongoing valsartan recalls

17 active

Reported	Class	Recall	Company	Reason	Where
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 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
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 PharmaceuticalsValsartan	Mylan Pharmaceuticals	Nitrosamine Impurity	Nationwide

All valsartan recalls, newest first

27 total

Reported	Class	Recall	Company	Reason	Where
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 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 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
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 PharmaceuticalsValsartan	Mylan Pharmaceuticals	Nitrosamine Impurity	Nationwide
19 Dec 2018Drug	CLASS II	Valsartan Tablets, USP 40 mg recalled by Mylan Laboratories LimitedValsartan	Mylan Laboratories Limited, (Nashik FDF)	Nitrosamine Impurity	Nationwide
19 Dec 2018Drug	CLASS II	Valsartan Tablets, USP, 160 mg recalled by Mylan PharmaceuticalsValsartan	Mylan Pharmaceuticals	Nitrosamine Impurity	Nationwide
19 Dec 2018Drug	CLASS II	Valsartan Tablets, USP, 40 mg recalled by Mylan PharmaceuticalsValsartan	Mylan Pharmaceuticals	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.