BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
Recalling Firm / Manufacturer: Glenmark Pharmaceuticals Inc., USA
(Elmwood Park, NJ, United States)
FDA Recall Number: D-0199-2026
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
Generic Name
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
Active Substance(s)
Bisoprolol Fumarate, Hydrochlorothiazide
Administration Route
Oral
National Drug Code (NDC)
68462-878
Total Quantity Recalled
11,136 bottles
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
Full Product Description
Packaging specifications and labeling details
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.
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class III
Current Action Status
Ongoing
FDA Enforcement Report Date
December 10, 2025
Firm Initiation Date
November 21, 2025
FDA Classification Date
Dec 01, 2025
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
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
Distribution Information
Geographic scope of affected shipments
Nationwide in the USA
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Advisory Notice
This Class III recall involves technical or packaging non-conformities that are not expected to cause adverse health consequences. Consult your pharmacist if you have questions.
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0199-2026
Questo Retrieval Date: July 31, 2026 14:36 1785508608UTCC