Glenmark Pharmaceuticals Inc., USA: Drug Recall

Recall Details

Recall Number

D-0199-2026

Classification

Class III

Product Type

Drug

Recalling Firm

Glenmark Pharmaceuticals Inc., USA

Status

Ongoing

Date Initiated

11/21/2025

Location

Elmwood Park, NJ, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

11,136 bottles

Reason for Recall

Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe

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.

Distribution Pattern

Nationwide in the USA

Other Recalls by Glenmark Pharmaceuticals Inc., USA

• Class II: Risk 12/30/2025
  Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.
• Class III: Low Risk 11/18/2025
  Cross Contamination with Other Products
• Class II: Risk 09/17/2025
  CGMP Deviations: Market complaints received for gritty texture (grainy)
• Class II: Risk 09/03/2025
  Failed Impurities/Degradation Specifications
• Class II: Risk 08/08/2025
  Failed Dissolution Specifications: Failure results (above) were reported for the Dissolution (by UV) test for commercial annual stability at the long-term shelf life stability interval, wherein the dissolution results do not comply with L3 stage dissolution criteria.

View all recalls by Glenmark Pharmaceuticals Inc., USA →