Telmisartan and Amlodipine Tablets 80 mg/5 mg — Class III drug recall D-1121-2019
Terminated recall by Lupin Pharmaceuticals Inc., reported 2019-04-17, distributed nationwide. Failed Impurities/Degradation Specifications; 18 month long term stability study.
| Recall number | D-1121-2019 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lupin Pharmaceuticals Inc., Baltimore, MD, United States |
| Recall initiated | 2019-04-01 |
| Classified | 2019-04-11 |
| Reported by FDA | 2019-04-17 |
| Terminated | 2020-07-01 |
| Distributed | Nationwide (US) |
| Quantity | 12,504 bottles |
| Reason classes | specification failure |
| NDC | 68180-0196, 68180-0196-06, 68180-0196-09, 68180-0196-12, 68180-0197, 68180-0197-06, 68180-0197-07, 68180-0197-09, 68180-0197-12, 68180-0198, 68180-0198-06, 68180-0198-09, 68180-0198-12, 68180-0199, 68180-0199-06, 68180-0199-09, 68180-0199-12 |
Product
Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablet bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by : Lupin Limited, Goa, INDIA -- NDC 68180-198-06
Reason for recall
Failed Impurities/Degradation Specifications; 18 month long term stability study.
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-1121-2019. 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.