FlaggedRx · Recall check

Glenmark: FDA recalls & import-alert status

Checked live against FDA · Jul 06, 2026

🚨 On FDA Import Alert 66-40 (the Red List) — matched 1 entr(y/ies), placement 2022-10-25. Shipments detained at the US border. About 66-40 →

We match records conservatively on the name “Glenmark”. Manufacturers appear under many legal-name variants and subsidiaries; we deliberately favor showing fewer, confident matches over wrongly merging firms, so this may not capture every record. A flag is shown with its FDA source; the absence of a flag is never an all-clear and never a clearance. For name-variant resolution across FDA, MHRA, and CDSCO, run a Supplier Risk Check.

FDA recall records matching this name

Class IIALYACEN 1/352026-06-24

Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.

Recalling firm: Glenmark Pharmaceuticals Inc., USA

Class IIONDANSETRON2026-01-07

Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Phar

Recalling firm: Glenmark Pharmaceuticals Inc., USA

Class IIINEBIVOLOL2025-12-17

Cross Contamination with Other Products

Recalling firm: Glenmark Pharmaceuticals Inc., USA

Class IIIBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE2025-12-10

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

Recalling firm: Glenmark Pharmaceuticals Inc., USA

Class IIVIORELE2025-10-22

Failed Impurities/Degradation Specifications

Recalling firm: Glenmark Pharmaceuticals Inc., USA

Class IIAZELAIC ACID2025-10-01

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

Recalling firm: Glenmark Pharmaceuticals Inc., USA

Class IICARVEDILOL2025-08-20

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

Recalling firm: Glenmark Pharmaceuticals Inc., USA

Class IICARVEDILOL2025-08-20

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

Recalling firm: Glenmark Pharmaceuticals Inc., USA

Class IICARVEDILOL2025-08-20

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

Recalling firm: Glenmark Pharmaceuticals Inc., USA

Class IITHEOPHYLLINE2025-08-20

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 inte

Recalling firm: Glenmark Pharmaceuticals Inc., USA

Class IICARVEDILOL2025-08-20

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

Recalling firm: Glenmark Pharmaceuticals Inc., USA

Class IICARVEDILOL2025-08-20

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

Recalling firm: Glenmark Pharmaceuticals Inc., USA

Class IIIEZETIMIBE AND SIMVASTATIN2025-06-18

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 s

Recalling firm: Glenmark Pharmaceuticals Inc., USA

Class IICARVEDILOL2025-06-04

CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit

Recalling firm: Glenmark Pharmaceuticals Inc., USA

Class IICARVEDILOL2025-06-04

CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit

Recalling firm: Glenmark Pharmaceuticals Inc., USA

Class IITHEOPHYLLINE2025-06-04

OOS results reported for the Dissolution (by UV) test.

Recalling firm: Glenmark Pharmaceuticals Inc., USA

Class IICARVEDILOL2025-06-04

CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit

Recalling firm: Glenmark Pharmaceuticals Inc., USA

Class IICARVEDILOL2025-06-04

CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit

Recalling firm: Glenmark Pharmaceuticals Inc., USA

Class IICETIRIZINE HCL2025-04-16

CGMP Deviations

Recalling firm: Glenmark Pharmaceuticals Inc., USA

Class IIRANOLAZINE2025-04-16

CGMP Deviations

Recalling firm: Glenmark Pharmaceuticals Inc., USA

Class IIPRAVASTATIN SODIUM2025-04-16

CGMP Deviations

Recalling firm: Glenmark Pharmaceuticals Inc., USA

Class IIFENOFIBRATE2025-04-16

CGMP Deviations

Recalling firm: Glenmark Pharmaceuticals Inc., USA

Class IIFROVATRIPTAN SUCCINATE2025-04-16

CGMP Deviations

Recalling firm: Glenmark Pharmaceuticals Inc., USA

Class IINAPROXEN SODIUM2025-04-16

CGMP Deviations

Recalling firm: Glenmark Pharmaceuticals Inc., USA

Class IIPRAVASTATIN SODIUM2025-04-16

CGMP Deviations

Recalling firm: Glenmark Pharmaceuticals Inc., USA

Class IIMETFORMIN HYDROCHLORIDE2025-04-16

CGMP Deviations

Recalling firm: Glenmark Pharmaceuticals Inc., USA

Class IISOLIFENACIN SUCCINATE2025-04-16

CGMP Deviations

Recalling firm: Glenmark Pharmaceuticals Inc., USA

Class IIGABAPENTIN2025-04-16

CGMP Deviations

Recalling firm: Glenmark Pharmaceuticals Inc., USA

Class IIProchlorperazine Maleate Tablets, 10mg, 100-count bottles, Rx Only, Ma2025-04-16

CGMP Deviations

Recalling firm: Glenmark Pharmaceuticals Inc., USA

Class IISAXAGLIPTIN2025-04-16

CGMP Deviations

Recalling firm: Glenmark Pharmaceuticals Inc., USA

Class IILACOSAMIDE2025-04-16

CGMP Deviations

Recalling firm: Glenmark Pharmaceuticals Inc., USA

Class IIPROPAFENONE HYDROCHLORIDE2025-04-16

CGMP Deviations

Recalling firm: Glenmark Pharmaceuticals Inc., USA

Class IIVORICONAZOLE2025-04-16

CGMP Deviations

Recalling firm: Glenmark Pharmaceuticals Inc., USA

Class IICOLESEVELAM HYDROCHLORIDE2025-04-16

CGMP Deviations

Recalling firm: Glenmark Pharmaceuticals Inc., USA

Class IISAXAGLIPTIN2025-04-16

CGMP Deviations

Recalling firm: Glenmark Pharmaceuticals Inc., USA

Class IINITROGLYCERIN2025-04-16

CGMP Deviations

Recalling firm: Glenmark Pharmaceuticals Inc., USA

Class IIACETAMINOPHEN, IBUPROFEN2025-04-16

CGMP Deviations

Recalling firm: Glenmark Pharmaceuticals Inc., USA

Class IILACOSAMIDE2025-04-16

CGMP Deviations

Recalling firm: Glenmark Pharmaceuticals Inc., USA

Class IIPRAVASTATIN SODIUM2025-04-16

CGMP Deviations

Recalling firm: Glenmark Pharmaceuticals Inc., USA

Class IICARVEDILOL2025-04-16

CGMP Deviations

Recalling firm: Glenmark Pharmaceuticals Inc., USA

Class IIPROPAFENONE HYDROCHLORIDE2025-04-16

CGMP Deviations

Recalling firm: Glenmark Pharmaceuticals Inc., USA

Class IIRUFINAMIDE2025-04-16

CGMP Deviations

Recalling firm: Glenmark Pharmaceuticals Inc., USA

Class IIPRAVASTATIN SODIUM2025-04-16

CGMP Deviations

Recalling firm: Glenmark Pharmaceuticals Inc., USA

Class IIDILTIAZEM HYDROCHLORIDE2025-04-16

CGMP Deviations

Recalling firm: Glenmark Pharmaceuticals Inc., USA

Class IILACOSAMIDE2025-04-16

CGMP Deviations

Recalling firm: Glenmark Pharmaceuticals Inc., USA

Class IIFLUPHENAZINE HYDROCHLORIDE2025-04-16

CGMP Deviations

Recalling firm: Glenmark Pharmaceuticals Inc., USA

Class IIPROPAFENONE HYDROCHLORIDE2025-04-16

CGMP Deviations

Recalling firm: Glenmark Pharmaceuticals Inc., USA

Class IIROSUVASTATIN CALCIUM2025-04-16

CGMP Deviations

Recalling firm: Glenmark Pharmaceuticals Inc., USA

Class IIINDOMETHACIN2025-04-16

CGMP Deviations

Recalling firm: Glenmark Pharmaceuticals Inc., USA

Class IICLINDAMYCIN HYDROCHLORIDE2025-04-16

CGMP Deviations

Recalling firm: Glenmark Pharmaceuticals Inc., USA

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