Drug recall D-0199-2026
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
Lots and codes
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
Recall details
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA, Elmwood Park, NJ
- Quantity
- 11,136 bottles
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- November 21, 2025
Related products
- Bisoprolol fumarate and hydrochlorothiazide – drug information
- NDC 68462-879 Bisoprolol Fumarate and Hydrochlorothiazide · Bisoprolol Fumarate 5 mg/1; Hydrochlorothiazide 6.25 mg/1 · GLENMARK PHARMACEUTICALS INC., USA
- NDC 68462-880 Bisoprolol Fumarate and Hydrochlorothiazide · Bisoprolol Fumarate 10 mg/1; Hydrochlorothiazide 6.25 mg/1 · GLENMARK PHARMACEUTICALS INC., USA
- NDC 68462-878 Bisoprolol Fumarate and Hydrochlorothiazide · Bisoprolol Fumarate 2.5 mg/1; Hydrochlorothiazide 6.25 mg/1 · GLENMARK PHARMACEUTICALS INC., USA