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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 61–80 of 108 recalls

Atomoxetine 80mg Capsules (Glenmark) – Impurity Excess (2025)

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Class IIModerate

FDAJan 29, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Atomoxetine 18mg Capsules (Glenmark) – Impurity Excess (2025)

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Class IIModerate

FDAJan 29, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Atomoxetine 25mg Capsules (Glenmark) – Impurity Excess (2025)

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

1 2 345 6

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Class II

Moderate

FDAJan 29, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Atomoxetine 18mg Capsules (Glenmark) – Impurity Excess (2025)

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Class IIModerate

FDAJan 29, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Atomoxetine Capsules 40mg (Glenmark) – Impurity Risk (2025)

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Class IIModerate

FDAJan 29, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Atomoxetine Capsules 100mg (Glenmark) – Impurity Risk (2025)

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Class IIModerate

FDAJan 29, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Atomoxetine 25mg Capsules (Glenmark) – Impurity Excess (2025)

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Class IIModerate

FDAJan 29, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Atomoxetine Capsules 60mg (Glenmark) – Impurity Risk (2025)

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Class IIModerate

FDAJan 29, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Atomoxetine 60mg Capsules (Glenmark) – Impurity Excess (2025)

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Class IIModerate

FDAJan 29, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Atomoxetine 10mg Capsules (Glenmark) – Impurity Excess (2025)

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Class IIModerate

FDAJan 29, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Carvedilol Tablets 12.5mg (Glenmark) – Impurity Risk (2025)

CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.

Class IIModerate

FDAJan 22, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Carvedilol Tablets 25mg (Glenmark) – Impurity Risk (2025)

CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.

Class IIModerate

FDAJan 22, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Chlorpromazine Tablets 25mg (Glenmark) – Impurity Limit Exceeded (2024)

CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.

Class IIModerate

FDADec 11, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Chlorpromazine Tablets 10mg (Glenmark) – Impurity Limit Exceeded (2024)

CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.

Class IIModerate

FDADec 11, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Diltiazem Hydrochloride Capsules 60mg (Glenmark) – Impurity Risk (2024)

cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.

Class IIModerate

FDANov 1, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Diltiazem Hydrochloride Capsules 60mg (Glenmark) – Impurity Risk (2024)

cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.

Class IIModerate

FDANov 1, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Diltiazem Hydrochloride Capsules 90mg (Glenmark) – Impurity Risk (2024)

cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.

Class IIModerate

FDANov 1, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Diltiazem Hydrochloride Capsules 90mg (Glenmark) – Impurity Risk (2024)

cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.

Class IIModerate

FDANov 1, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Diltiazem Hydrochloride Capsules 120mg (Glenmark) – Impurity Risk (2024)

cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.

Class IIModerate

FDANov 1, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Diltiazem Hydrochloride Capsules 120mg (Glenmark) – Impurity Risk (2024)

cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.

Class IIModerate

FDANov 1, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA