FDA Drug recall D-0085-2024
Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 5mg/6.25mg, 100-count Bottle, RX only, Manufactured by: Glenmark Pharmaceuticals…
- FDA Drug
- Class III
- terminated
- Published 2023-11-08
On 2023-11-08 the FDA classified a Class III recall of Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 5mg/6.25mg, 100-count Bottle, RX only, Manufactured by: Glenmark Pharmaceuticals… by Glenmark Pharmaceuticals Usa, citing failed Impurities/Degradation Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0085-2024 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2023-10-20 |
| Published | 2023-11-08 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Glenmark Pharmaceuticals Usa |
| Distribution | US |
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
Failed Impurities/Degradation Specifications
Identifiers
| ndc | 68462-878-30 |
|---|---|
| ndc | 68462-878-01 |
| ndc | 68462-878-05 |
| ndc | 68462-879-30 |
| ndc | 68462-879-01 |
| ndc | 68462-879-05 |
| ndc | 68462-880-30 |
| ndc | 68462-880-01 |
| ndc | 68462-880-05 |
| code_info | Lot# 17212352, Exp 11/31/2023 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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FDA Drug · Class III · 2025-12-17 · Glenmark Pharmaceuticals Usa - Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a) 30-count bottles, NDC-68462-878-30
FDA Drug · Class III · 2025-12-10 · Glenmark Pharmaceuticals Usa
All Glenmark Pharmaceuticals Usa recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0085-2024%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.