Amlodipine and Valsartan Tablets USP 10mg/160mg — Class II drug recall D-1036-2019
Ongoing recall by Aurobindo Pharma USA Inc., reported 2019-03-27, distributed nationwide. GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA)
| Recall number | D-1036-2019 |
|---|---|
| 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 | 2019-03-21 |
| Reported by FDA | 2019-03-27 |
| Distributed | Nationwide (US) |
| Reason classes | chemical contamination, 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 | OCT-2019, VFSA17007-A |
Product
Amlodipine and Valsartan Tablets USP 10mg/160mg, 30 count bottles, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ Manufactured by: Aurobindo Pharma Limited, India --- NDC 65862-739-30
Reason for recall
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
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-1036-2019. 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.