FDA Drug recall D-0199-2026
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
- ongoing
- Published 2025-12-10
On 2025-12-10 the FDA classified a Class III recall of Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a) 30-count bottles, NDC-68462-878-30 by Glenmark Pharmaceuticals Usa, citing cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0199-2026 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2025-11-21 |
| Published | 2025-12-10 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Glenmark Pharmaceuticals Usa |
| Distribution | US |
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
Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
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 #: (a): Lot 17232401, exp 11/2025; Lot 17240974, exp 05/2026 (b): Lot 17232401, exp 11/2025; Lot 17240974, exp 05/2…Lot #: (a): Lot 17232401, exp 11/2025; Lot 17240974, exp 05/2026 (b): Lot 17232401, exp 11/2025; Lot 17240974, exp 05/2026 (c): Lot 17232401, exp 11/2025; Lot 17240974, exp 05/2026 |
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-0199-2026%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.