Amlodipine — Class II drug recall D-1141-2018
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-1141-2018 |
|---|---|
| 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 | 169,200 bottles |
| Reason classes | cgmp, specification failure |
| NDC | 13668-0325-30 |
| Lot numbers | BBX2C007, BBX2D001, BBX2D002, BBX2D003, BBX2D004, BBX2D005, BBX2D006, BBX2D007, BBX2D008, BBX2D009, BBX2D010, BBX2D011, BBX2D012, BBX2D013, BBX2D014, BBX2D015, BBX2D016, BBX2D017, BBX2D018, BBX2D019, BBX2D020, BBX2D021, BBX2D022, BBX2D023, BBX2D024, BBX2D025, BBX2D026, BBX2E001, BBX2E002, BBX2E003, BBX2E004, BBX2E005 |
Product
Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/320 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-325-30
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-1141-2018. 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.