Bisoprolol Fumarate and Hydrochlorothiazide Tablets — Class III drug recall D-0085-2024
Terminated recall by Glenmark Pharmaceuticals Inc., USA, reported 2023-11-08, distributed nationwide. Failed Impurities/Degradation Specifications
| Recall number | D-0085-2024 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ, United States |
| Recall initiated | 2023-10-20 |
| Classified | 2023-11-02 |
| Reported by FDA | 2023-11-08 |
| Terminated | 2024-08-16 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 68462-0878, 68462-0878-01, 68462-0878-05, 68462-0878-30, 68462-0879, 68462-0879-01, 68462-0879-05, 68462-0879-30, 68462-0880, 68462-0880-01, 68462-0880-05, 68462-0880-30 |
| Lot numbers | 17212352 |
Product
Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 5mg/6.25mg, 100-count Bottle, RX only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC 68462-879-01
Reason for recall
Failed Impurities/Degradation Specifications
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-0085-2024. 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.