Amlodipine and Valsartan Tablets USP 10 mg/160 mg — Class II drug recall D-0362-2019
Ongoing recall by Aurobindo Pharma USA Inc., reported 2019-01-23, distributed nationwide. CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API us
| Recall number | D-0362-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aurobindo Pharma USA Inc., East Windsor, NJ, United States |
| Recall initiated | 2018-12-31 |
| Classified | 2019-01-14 |
| Reported by FDA | 2019-01-23 |
| Distributed | Nationwide (US) |
| Quantity | 60,417 bottles |
| Reason classes | chemical contamination, cgmp, specification failure |
| NDC | 65862-0737, 65862-0737-03, 65862-0737-10, 65862-0737-30, 65862-0737-90, 65862-0738, 65862-0738-03, 65862-0738-10, 65862-0738-30, 65862-0738-90, 65862-0739, 65862-0739-03, 65862-0739-10, 65862-0739-30, 65862-0739-90, 65862-0740, 65862-0740-03, 65862-0740-10, 65862-0740-30, 65862-0740-90 |
| Lot numbers | VFSA17008-A, VFSA17009-A, VFSA17010-A, VFSA18002-A, VFSA18003-A, VFSA18007-A, VFSA18008-A, VKSA17008-A, VKSA17014-A, VKSA17015-A, VKSA17016-A, VKSA17017-A, VKSA18002-A, VKSA18004-A |
| Expiration dates | 2019-05, 2019-10, 2020-01, 2020-03 |
Product
Amlodipine and Valsartan Tablets USP 10 mg/160 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-739-30.
Reason for recall
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0362-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.