Amlodipine And Valsartan recalls

Amlodipine And Valsartan products have been recalled 12 times, most recently on 27 Mar 2019. The recalling company is usually Aurobindo Pharma USA. The most common reason is nitrosamine impurity.

Total recalls12since 2018
Last 12 months0reported
Class I00% of total
Ongoing12latest 27 Mar 2019

Recalls per month, last 24 months

click a bar for that month

Severity split

Class I 0 0%Class II 12 100%Class III 0 0%

Why amlodipine and valsartan is recalled

Product types

By year

Ongoing amlodipine and valsartan recalls

12 active

All amlodipine and valsartan recalls, newest first

12 total
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIAmlodipine and Valsartan Tablets USP 10mg/160mg recalledAmlodipine And ValsartanAurobindo Pharma USANitrosamine ImpurityNationwide
DrugCLASS IIAmlodipine and Valsartan Tablets USP 10 mg/160 mg recalledAmlodipine And ValsartanAurobindo Pharma USANitrosamine ImpurityNationwide
DrugCLASS IIAmlodipine and Valsartan Tablets USP 5 mg/160 mg recalledAmlodipine And ValsartanAurobindo Pharma USANitrosamine ImpurityNationwide
DrugCLASS IIAmlodipine and Valsartan Tablets USP 5 mg/320 mg recalledAmlodipine And ValsartanAurobindo Pharma USANitrosamine ImpurityNationwide
DrugCLASS IIAmlodipine and Valsartan Tablets USP 10 mg/320 mg recalledAmlodipine And ValsartanAurobindo Pharma USANitrosamine ImpurityNationwide
DrugCLASS IIAmlodipine and Valsartan Tablets, USP 10/320 mg recalledAmlodipine And ValsartanMylan Laboratories Limited, (Nashik FDF)Nitrosamine ImpurityNationwide
DrugCLASS IIAmlodipine and Valsartan Tablets, USP 5/320 mg recalledAmlodipine And ValsartanMylan Laboratories Limited, (Nashik FDF)Nitrosamine ImpurityNationwide
DrugCLASS IIAmlodipine and Valsartan Tablets, USP 5/160 mg recalledAmlodipine And ValsartanMylan Laboratories Limited, (Nashik FDF)Nitrosamine ImpurityNationwide
DrugCLASS IIAmlodipine and Valsartan Tablets, USP 10/160 mg recalledAmlodipine And ValsartanMylan Laboratories Limited, (Nashik FDF)Nitrosamine ImpurityNationwide
DrugCLASS IIAmlodipine and Valsartan Tablets, USP, 5 mg/160 mg recalledAmlodipine And ValsartanMylan PharmaceuticalsNitrosamine ImpurityNationwide
DrugCLASS IIAmlodipine and Valsartan Tablets, USP, 10 mg/320 mg recalledAmlodipine And ValsartanMylan PharmaceuticalsNitrosamine ImpurityNationwide
DrugCLASS IIAmlodipine and Valsartan Tablets, USP,10 mg/160 mg recalledAmlodipine And ValsartanMylan PharmaceuticalsNitrosamine ImpurityNationwide

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.