Bisoprolol Fumarate And Hydrochlorothiazide Tablet, Film Coated
FDA Recall NDC 68462-879
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Bisoprolol Fumarate And Hydrochlorothiazide (NDC 68462-879). A significant event, classified as Class III, was initiated on Nov 21, 2025 by Glenmark Pharmaceuticals Inc., Usa. The reported reason for this action was: "Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class III Ongoing
Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
Nov 21, 2025
Dec 10, 2025
11,136 bottles
Recall Profile & Regulatory Data
Event ID
98036
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
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.
Batch or Lot Expiration Information
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
Affected Packages Involved in this Recall
68462-878-30Product
68462-878-01Product
68462-878-05Product
68462-879-30Product
68462-879-01Product
68462-879-05Product
68462-880-30Product
68462-880-01Product
68462-880-05Product
October 2023 Class III Recall: Failed Impurities/Degradation Specifications
Recall Number
Class III Terminated
Failed Impurities/Degradation Specifications
Oct 20, 2023
Nov 08, 2023
480 100-count bottles
Recall Profile & Regulatory Data
Event ID
93252
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Aug 16, 2024
Product Description
Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 5mg/6.25mg, 100-count Bottle, RX only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC 68462-879-01
Batch or Lot Expiration Information
Lot# 17212352, Exp 11/31/2023
Affected Packages Involved in this Recall
68462-878-30Product
68462-878-01Product
68462-878-05Product
68462-879-30Product
68462-879-01Product
68462-879-05Product
68462-880-30Product
68462-880-01Product
68462-880-05Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
