Glenmark Pharmaceuticals Inc., USA Recalls

All product recalls associated with Glenmark Pharmaceuticals Inc., USA.

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Recall Summary

Total Recalls

108

Past Year

72

Class I (Serious)

2

Most Recent

Nov 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–20 of 108 recalls

Bisoprolol/Hydrochlorothiazide Tablets (Glenmark) – Cross Contamination (2025)

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

Class III

FDANov 21, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Nebivolol Tablets (Glenmark) – Cross Contamination (2025)

Cross Contamination with Other Products

Class III

FDANov 18, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Azelaic Acid Gel (Glenmark) – Texture Complaint (2025)

CGMP Deviations: Market complaints received for gritty texture (grainy)

Class II

FDASep 17, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Viorele (Glenmark) – Impurity specification failure (2025)

Failed Impurities/Degradation Specifications

Class II

FDASep 3, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Theophylline Tablets (Glenmark) - Failed Dissolution (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.

Class II

FDAAug 8, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Carvedilol Tablets 3.125mg (Glenmark) - Nitrosamine Impurity (2025)

CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.

Class II

FDAAug 7, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Carvedilol Tablets 25mg (Glenmark) - Nitrosamine Impurity (2025)

CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.

Class II

FDAAug 7, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Carvedilol Tablets 12.5mg (Glenmark) - Nitrosamine Impurity (2025)

CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.

Class II

FDAAug 7, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Carvedilol Tablets 25mg (Glenmark) - Nitrosamine Excess (2025)

CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm

Class II

FDAAug 6, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Carvedilol Tablets 12.5mg (Glenmark) - Nitrosamine Excess (2025)

CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm

Class II

FDAAug 6, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Ezetimibe and Simvastatin Tablets (Glenmark) – Impurity Specification Failure (2025)

Failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time point during long-term stability study.

Class III

FDAMay 19, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA