Bisoprolol Fumarate and Hydrochlorothiazide Tablets — Class III drug recall D-0199-2026
Ongoing recall by Glenmark Pharmaceuticals Inc., USA, reported 2025-12-10, distributed nationwide. Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
| Recall number | D-0199-2026 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Glenmark Pharmaceuticals Inc., USA, Elmwood Park, NJ, United States |
| Recall initiated | 2025-11-21 |
| Classified | 2025-12-01 |
| Reported by FDA | 2025-12-10 |
| Distributed | Nationwide (US) |
| Quantity | 11,136 bottles |
| 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 | 17232401, 17240974 |
| Expiration dates | 2025-11, 2026-05 |
Product
Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a) 30-count bottles, NDC-68462-878-30; (b) 100-count bottle, NDC-68462-878-01; (c) 500-count bottles, NDC-68462-878-05; Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, Inda. Manufactured for: Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430.
Reason for recall
Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
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-0199-2026. 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.