Trandolapril and Verapamil Hydrochloride Extended-Release Tablets 2… — Class III drug recall D-1095-2023
Ongoing recall by Glenmark Pharmaceuticals Inc., USA, reported 2023-08-30, distributed nationwide. Subpotent: Out of Specification for Assay Test at the 3-month time point.
| Recall number | D-1095-2023 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ, United States |
| Recall initiated | 2023-08-14 |
| Classified | 2023-08-22 |
| Reported by FDA | 2023-08-30 |
| Distributed | Nationwide (US) |
| Quantity | 1,200 bottles |
| Reason classes | potency, specification failure |
| NDC | 68462-0294, 68462-0294-01, 68462-0294-10, 68462-0294-90, 68462-0295, 68462-0295-01, 68462-0295-10, 68462-0295-90, 68462-0296, 68462-0296-01, 68462-0296-10, 68462-0296-90, 68462-0329, 68462-0329-01, 68462-0329-10 |
| Lot numbers | 19224744 |
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 for recall
Subpotent: Out of Specification for Assay Test at the 3-month time point.
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-1095-2023. 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.