FDA Drug recall D-1121-2019
Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablet bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD, Man…
- FDA Drug
- Class III
- terminated
- Published 2019-04-17
On 2019-04-17 the FDA classified a Class III recall of Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablet bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD, Man… by Lupin Pharmaceuticals, citing failed Impurities/Degradation Specifications; 18 month long term stability study.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1121-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-04-01 |
| Published | 2019-04-17 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Lupin Pharmaceuticals |
| Distribution | US |
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
Failed Impurities/Degradation Specifications; 18 month long term stability study.
Identifiers
| ndc | 68180-196-06 |
|---|---|
| ndc | 68180-196-09 |
| ndc | 68180-196-12 |
| ndc | 68180-197-06 |
| ndc | 68180-197-09 |
| ndc | 68180-197-12 |
| ndc | 68180-197-07 |
| ndc | 68180-198-06 |
| ndc | 68180-198-09 |
| ndc | 68180-198-12 |
| ndc | 68180-199-06 |
| ndc | 68180-199-09 |
| ndc | 68180-199-12 |
| code_info | G705843 Exp. date April, 2019 G707763 Exp. date August, 2019 G800434 Exp. date November, 2019 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1121-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.