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Glenmark Pharmaceuticals Inc., USA

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

Class I (Serious)

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 81–100 of 108 recalls

Ciclopirox Gel (Glenmark) – Broken Tube Seal (2024)

Defective Container: Firm received complaints of broken tube at the seal.

Class IIILow

FDASep 30, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Ryaltris Nasal Spray (Glenmark) – Clogged Delivery System (2024)

Defective Delivery System: The dip tube is clogged causing the spray not to work.

Class IIModerate

FDASep 24, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Indomethacin Capsules (Glenmark) – Dissolution Specification Failure (2024)

Failed Dissolution Specifications: below specification results

Class II

1...3 456

Page 5 of 6Next

Moderate

FDAJul 31, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Azelaic Acid Gel (Glenmark) – CGMP Deviation (2024)

CGMP Deviations

Class IIModerate

FDAJul 22, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Pravastatin Sodium Tablets (Glenmark) – Dissolution Failure (2024)

Failed Dissolution Specifications: results below specifications

Class IIModerate

FDAJun 28, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Potassium Chloride Capsules (Glenmark) – CGMP Deviations (2024)

CGMP Deviations

Class IIModerate

FDAMay 30, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Potassium Chloride Capsules (Glenmark) – CGMP Deviations (2024)

CGMP Deviations

Class IIModerate

FDAMay 30, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Potassium Chloride Capsules (Glenmark) – Dissolution Failed (2024)

Failed Dissolution Specifications

Class IHigh

FDAMay 30, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Potassium Chloride Capsules (Glenmark) – Dissolution Failed (2024)

Failed Dissolution Specifications

Class IHigh

FDAMay 30, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Rizatriptan Tablets (Glenmark) – Impurity Concern (2024)

CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.

Class IIModerate

FDAMay 13, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Rizatriptan Benzoate Tablets (Glenmark) – Nitrosamine Impurity (2024)

CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.

Class IIModerate

FDAMay 13, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Rizatriptan Benzoate Tablets (Glenmark) – Nitrosamine Impurity (2024)

CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.

Class IIModerate

FDAMay 10, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Rizatriptan Benzoate Tablets (Glenmark) – Nitrosamine Impurity (2024)

CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.

Class IIModerate

FDAMay 10, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Diltiazem Hydrochloride (Glenmark) – Dissolution Failure (2024)

Failed Dissolution Specifications

Class IIModerate

FDAApr 17, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Diltiazem Extended-Release Capsules (Glenmark) – Dissolution Failure (2024)

Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study.

Class IIModerate

FDAMar 26, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA