Glenmark Pharmaceuticals Inc., USA

122 FDA enforcement actions

122 Total Recalls

2 Class I

110 Class II

10 Class III

Firm Details

Product Types: drug
States: NJ

All Recalls

Class II: Risk 12/30/2025 drug

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 11/21/2025 drug

Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
Class III: Low Risk 11/18/2025 drug

Cross Contamination with Other Products
Class II: Risk 09/17/2025 drug

CGMP Deviations: Market complaints received for gritty texture (grainy)
Class II: Risk 09/03/2025 drug

Failed Impurities/Degradation Specifications
Class II: Risk 08/08/2025 drug

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: Risk 08/07/2025 drug

CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Class II: Risk 08/07/2025 drug

CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Class II: Risk 08/07/2025 drug

CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Class II: Risk 08/06/2025 drug

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: Risk 08/06/2025 drug

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 III: Low Risk 05/19/2025 drug

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 II: Risk 05/15/2025 drug

OOS results reported for the Dissolution (by UV) test.
Class II: Risk 03/13/2025 drug

CGMP Deviations
Class II: Risk 03/13/2025 drug

CGMP Deviations
Class II: Risk 03/13/2025 drug

CGMP Deviations
Class II: Risk 03/13/2025 drug

CGMP Deviations
Class II: Risk 03/13/2025 drug

CGMP Deviations
Class II: Risk 03/13/2025 drug

CGMP Deviations
Class II: Risk 03/13/2025 drug

CGMP Deviations
Class II: Risk 03/13/2025 drug

CGMP Deviations
Class II: Risk 03/13/2025 drug

CGMP Deviations
Class II: Risk 03/13/2025 drug

CGMP Deviations
Class II: Risk 03/13/2025 drug

CGMP Deviations
Class II: Risk 03/13/2025 drug

CGMP Deviations
Class II: Risk 03/13/2025 drug

CGMP Deviations
Class II: Risk 03/13/2025 drug

CGMP Deviations
Class II: Risk 03/13/2025 drug

CGMP Deviations
Class II: Risk 03/13/2025 drug

CGMP Deviations
Class II: Risk 03/13/2025 drug

CGMP Deviations
Class II: Risk 03/13/2025 drug

CGMP Deviations
Class II: Risk 03/13/2025 drug

CGMP Deviations
Class II: Risk 03/13/2025 drug

CGMP Deviations
Class II: Risk 03/13/2025 drug

CGMP Deviations
Class II: Risk 03/13/2025 drug

CGMP Deviations
Class II: Risk 03/13/2025 drug

CGMP Deviations
Class II: Risk 03/13/2025 drug

CGMP Deviations
Class II: Risk 03/13/2025 drug

CGMP Deviations
Class II: Risk 03/13/2025 drug

CGMP Deviations
Class II: Risk 03/13/2025 drug

CGMP Deviations
Class II: Risk 03/13/2025 drug

CGMP Deviations
Class II: Risk 03/13/2025 drug

CGMP Deviations
Class II: Risk 03/13/2025 drug

CGMP Deviations
Class II: Risk 03/13/2025 drug

CGMP Deviations
Class II: Risk 03/13/2025 drug

CGMP Deviations
Class II: Risk 03/13/2025 drug

CGMP Deviations
Class II: Risk 03/13/2025 drug

CGMP Deviations
Class II: Risk 03/13/2025 drug

CGMP Deviations
Class II: Risk 03/13/2025 drug

CGMP Deviations
Class II: Risk 03/13/2025 drug

CGMP Deviations
Class II: Risk 03/13/2025 drug

CGMP Deviations
Class II: Risk 03/13/2025 drug

CGMP Deviations
Class II: Risk 03/11/2025 drug

CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit.
Class II: Risk 02/28/2025 drug

CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Class II: Risk 02/28/2025 drug

CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Class II: Risk 02/28/2025 drug

CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Class II: Risk 02/28/2025 drug

CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Class II: Risk 01/29/2025 drug

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II: Risk 01/29/2025 drug

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II: Risk 01/29/2025 drug

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II: Risk 01/29/2025 drug

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II: Risk 01/29/2025 drug

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II: Risk 01/29/2025 drug

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II: Risk 01/29/2025 drug

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II: Risk 01/29/2025 drug

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II: Risk 01/29/2025 drug

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II: Risk 01/29/2025 drug

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II: Risk 01/29/2025 drug

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II: Risk 01/29/2025 drug

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II: Risk 01/29/2025 drug

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II: Risk 01/29/2025 drug

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II: Risk 01/22/2025 drug

CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
Class II: Risk 01/22/2025 drug

CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
Class II: Risk 12/11/2024 drug

CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
Class II: Risk 12/11/2024 drug

CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
Class II: Risk 11/01/2024 drug

cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class II: Risk 11/01/2024 drug

cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class II: Risk 11/01/2024 drug

cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class II: Risk 11/01/2024 drug

cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class II: Risk 11/01/2024 drug

cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class II: Risk 11/01/2024 drug

cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class III: Low Risk 09/30/2024 drug

Defective Container: Firm received complaints of broken tube at the seal.
Class II: Risk 09/24/2024 drug

Defective Delivery System: The dip tube is clogged causing the spray not to work.
Class II: Risk 08/30/2024 drug

Subpotent Drug
Class II: Risk 07/31/2024 drug

Failed Dissolution Specifications: below specification results
Class II: Risk 07/22/2024 drug

CGMP Deviations
Class II: Risk 06/28/2024 drug

Failed Dissolution Specifications: results below specifications
Class II: Risk 05/30/2024 drug

CGMP Deviations
Class I: Dangerous 05/30/2024 drug

Failed Dissolution Specifications
Class I: Dangerous 05/30/2024 drug

Failed Dissolution Specifications
Class II: Risk 05/30/2024 drug

CGMP Deviations
Class II: Risk 05/13/2024 drug

CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Class II: Risk 05/13/2024 drug

CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Class II: Risk 05/10/2024 drug

CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Class II: Risk 05/10/2024 drug

CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Class II: Risk 04/17/2024 drug

Failed Dissolution Specifications
Class II: Risk 03/26/2024 drug

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 II: Risk 01/04/2024 drug

Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol
Class II: Risk 11/07/2023 drug

Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen
Class II: Risk 11/07/2023 drug

Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen
Class III: Low Risk 10/23/2023 drug

Failed Impurities/Degradation Specifications:Out of Specification result reported for the test of organic impurities for the drug product,at the 18 month time point in long term stability study (25¿C/60% RH).
Class II: Risk 10/23/2023 drug

Failed Dissolution Specifications: Out of specification for dissolution.
Class II: Risk 10/20/2023 drug

Failed Dissolution Specifications
Class III: Low Risk 10/20/2023 drug

Failed Impurities/Degradation Specifications
Class III: Low Risk 08/14/2023 drug

Subpotent: Out of Specification for Assay Test at the 3-month time point.
Class III: Low Risk 07/11/2022 drug

Defective Container: Tube split from side seam
Class III: Low Risk 06/29/2022 drug

Failed Tablet/Capsule Specification : Capsule breakage
Class II: Risk 06/29/2022 drug

Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister .
Class II: Risk 06/29/2022 drug

Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister .
Class II: Risk 06/29/2022 drug

CGMP Deviations
Class III: Low Risk 06/16/2022 drug

Defective Container
Class II: Risk 04/25/2022 drug

cGMP deviations
Class II: Risk 04/25/2022 drug

cGMP deviations
Class II: Risk 04/25/2022 drug

cGMP deviations
Class II: Risk 08/27/2021 drug

Lack of Assurance of Sterility
Class II: Risk 08/27/2021 drug

CGMP Deviations
Class II: Risk 08/27/2021 drug

CGMP Deviations
Class II: Risk 08/27/2021 drug

CGMP Deviations
Class II: Risk 08/27/2021 drug

CGMP Deviations
Class II: Risk 08/27/2021 drug

CGMP Deviations
Class II: Risk 08/27/2021 drug

CGMP Deviations
Class II: Risk 08/27/2021 drug

Lack of Assurance of Sterility

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.