Class III
Ongoing
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.
This recall is currently active, issued December 10, 2025. It was issued by Glenmark Pharmaceuticals Inc., Usa.
- Recall Initiated
- November 21, 2025
- Posted
- December 10, 2025
- Recall Number
- D-0199-2026
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 11,136 bottles
- Firm Location
- Elmwood Park, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
Distribution
Nationwide in the USA
Lot / Code Info
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
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