Amlodipine and Valsartan Tablets — Class II drug recall D-1137-2018
Ongoing recall by Torrent Pharma Inc., reported 2018-09-05, distributed nationwide. CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
| Recall number | D-1137-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Torrent Pharma Inc., Basking Ridge, NJ, United States |
| Recall initiated | 2018-08-17 |
| Classified | 2018-08-28 |
| Reported by FDA | 2018-09-05 |
| Distributed | Nationwide (US) |
| Quantity | 89,616 bottles |
| Reason classes | cgmp, specification failure |
| NDC | 13668-0204-30 |
| Lot numbers | BV77C009, BV77C010, BV77C011, BV77D001, BV77D002, BV77D003, BV77D004, BV77D005, BV77D006, BV77D007, BV77D008, BV77D009, BV77D010, BV77D011, BV77D012, BV77D013 |
Product
Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-204-30
Reason for recall
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug 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-1137-2018. 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.