Glenmark recalls bisoprolol fumarate and hydrochlorothiazide tablets over traces of another drug
Testing of reserve samples found traces of ezetimibe, a different medicine, in these 2.5 mg/6.25 mg tablets, meaning they were cross-contaminated with another product during manufacturing.
What to do
The notice does not give instructions. Read the official notice for details.
Note from Recalled Today: Don't stop taking a prescribed medicine before you talk to your pharmacist or doctor.
Recall details
- 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.
- Hazard
- Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
- Units
- 11,136 bottles
- Where sold
- Nationwide in the USA
- FDA classification
- Class III · Ongoing
- Classified by FDA
- December 1, 2025
- Recall started
- November 21, 2025
- FDA enforcement report
- December 10, 2025
- Identifiers
- 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
- FDA recall number: D-0199-2026
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- 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
- Classification
- Class III (Ongoing)
- Distribution
- Nationwide in the USA
- Quantity
- 11,136 bottles
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