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-68462-8
Glenmark Pharmaceuticals is recalling Bisoprolol Fumarate and Hydrochlorothiazide Tablets (2.5 mg/6.25 mg) in 30-count, 100-count, and 500-count bottles nationwide because testing found traces of ezetimibe, a different medication, in the product due to cross-contamination during manufacturing. This is a Class I recall, the most serious type. The affected medication was distributed across all U.S. states and the District of Columbia.
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- 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
- Classification
- Class I
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2025-11-21
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Nationwide in the USA
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/c74dd983-d0ae-43bf-a289-7d5608e91f3d