FDA Drug recall D-1095-2023
Trandolapril and Verapamil Hydrochloride Extended-Release Tablets 2 mg / 180 mg, 100-count Bottle, Rx only, Manufactured by: Glenmark Pharm…
- FDA Drug
- Class III
- ongoing
- Published 2023-08-30
On 2023-08-30 the FDA classified a Class III recall of Trandolapril and Verapamil Hydrochloride Extended-Release Tablets 2 mg / 180 mg, 100-count Bottle, Rx only, Manufactured by: Glenmark Pharm… by Glenmark Pharmaceuticals Usa, citing subpotent: Out of Specification for Assay Test at the 3-month time point.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1095-2023 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2023-08-14 |
| Published | 2023-08-30 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Glenmark Pharmaceuticals Usa |
| Distribution | US |
Product
Trandolapril and Verapamil Hydrochloride Extended-Release Tablets 2 mg / 180 mg, 100-count Bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale -Bardez, Goa 403513, India, Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-295-01
Reason
Subpotent: Out of Specification for Assay Test at the 3-month time point.
Identifiers
| ndc | 68462-329-01 |
|---|---|
| ndc | 68462-329-10 |
| ndc | 68462-295-01 |
| ndc | 68462-295-10 |
| ndc | 68462-295-90 |
| ndc | 68462-296-01 |
| ndc | 68462-296-10 |
| ndc | 68462-296-90 |
| ndc | 68462-294-01 |
| ndc | 68462-294-10 |
| ndc | 68462-294-90 |
| code_info | Batch # 19224744 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1095-2023%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.