The Recall Desk

Manufacturer

Glenmark Pharmaceuticals Inc., USA

122 recalls in our database name Glenmark Pharmaceuticals Inc., USA as the manufacturing or recalling firm.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 122

  • HighFDA (Drugs)·D-0246-2026·2026-01-07

    Ondansetron Tablets Recalled Due to Unsealed Blister Packs

    Glenmark Pharmaceuticals is recalling Ondansetron 4mg tablets because blister packs are not fully sealed, allowing tablets to fall out. The recall affects 96,948 packs distributed nationwide, lot number 19251311.

    Product
    ONDANSETRON — ONDANSETRON (ONDANSETRON)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0222-2026·2025-12-17

    Nebivolol tablets recalled due to cross-contamination with other products

    Glenmark Pharmaceuticals is recalling 672 bottles of Nebivolol 20 mg tablets nationwide due to cross contamination with other products. The affected lot (17240988) expires 05/31/2026.

    Product
    NEBIVOLOL — NEBIVOLOL (NEBIVOLOL HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0199-2026·2025-12-10

    Bisoprolol and hydrochlorothiazide tablets recalled for cross-contamination with ezetimibe

    Glenmark Pharmaceuticals is recalling certain lots of bisoprolol fumarate and hydrochlorothiazide tablets nationwide due to trace cross-contamination with ezetimibe detected in testing.

    Product
    BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE — BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0021-2026·2025-10-22

    Viorele contraceptive recalled for failed impurity and degradation specifications

    Glenmark Pharmaceuticals is recalling 26,928 packs of Viorele contraceptive nationwide due to failed impurities and degradation specifications in batch 20230733.

    Product
    VIORELE — VIORELE (DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0662-2025·2025-10-01

    Azelaic Acid Gel Recall Due to Manufacturing Quality Defect

    Glenmark Pharmaceuticals recalls 13,824 tubes of Azelaic Acid Gel due to complaints of gritty texture resulting from manufacturing process deviations.

    Product
    AZELAIC ACID — AZELAIC ACID (AZELAIC ACID)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0577-2025·2025-08-20

    Carvedilol tablets recalled nationwide due to nitrosamine impurity

    Glenmark Pharmaceuticals is recalling Carvedilol 3.125 mg tablets due to nitrosamine impurity above acceptable levels. Approximately 44,328 bottles were distributed nationwide.

    Product
    CARVEDILOL — CARVEDILOL (CARVEDILOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0579-2025·2025-08-20

    Carvedilol Tablets Recalled Due to Nitrosamine Impurity Contamination

    Glenmark Pharmaceuticals is recalling 4,800 bottles of Carvedilol 25 mg tablets nationwide due to the presence of N-Nitroso Carvedilol I impurity above FDA-acceptable intake levels. The manufacturing deviation was identified during quality testing.

    Product
    CARVEDILOL — CARVEDILOL (CARVEDILOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0578-2025·2025-08-20

    Carvedilol Tablets Recalled Due to Nitrosamine Impurity Above Acceptable Levels

    Glenmark Pharmaceuticals is recalling Carvedilol 12.5 mg tablets (Lot #19243202, expires 7/31/2026) due to N-Nitroso Carvedilol I nitrosamine impurity exceeding FDA acceptable intake levels. The recall affects 6,432 bottles distributed nationwide.

    Product
    CARVEDILOL — CARVEDILOL (CARVEDILOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0588-2025·2025-08-20

    Carvedilol Tablets Recalled for N-Nitroso Impurity Above FDA Limits

    Glenmark Pharmaceuticals is recalling Carvedilol 25 mg tablets nationwide because testing found an impurity (NNCI) at levels above FDA's recommended safety limit. The recall affects 14,976 bottles.

    Product
    CARVEDILOL — CARVEDILOL (CARVEDILOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0587-2025·2025-08-20

    Carvedilol tablets recalled nationwide for excess N-nitroso impurity

    Glenmark Pharmaceuticals is recalling 17,496 bottles of Carvedilol 12.5 mg tablets nationwide due to manufacturing defects. Tests found N-nitroso impurity levels above FDA limits.

    Product
    CARVEDILOL — CARVEDILOL (CARVEDILOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0462-2025·2025-06-18

    Ezetimibe and Simvastatin tablets recalled for impurity specification failure

    Glenmark Pharmaceuticals is recalling Ezetimibe and Simvastatin 10mg/40mg tablets (Lot 17240195) distributed nationwide due to out-of-specification impurity levels detected during stability testing.

    Product
    EZETIMIBE AND SIMVASTATIN — EZETIMIBE AND SIMVASTATIN (EZETIMIBE AND SIMVASTATIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0451-2025·2025-06-04

    Carvedilol Tablets Recalled for N-Nitroso Impurity Above Acceptable Limits

    Glenmark Pharmaceuticals is recalling 18,696 bottles of Carvedilol 25mg tablets nationwide due to manufacturing violations and N-nitroso impurity above acceptable intake limits. Affected lots are 19231107, 19231114, 19231152, and 19234866.

    Product
    CARVEDILOL — CARVEDILOL (CARVEDILOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0449-2025·2025-06-04

    Prescription Drug Recall: Carvedilol Tablets Due to Manufacturing Impurity

    Glenmark Pharmaceuticals recalls Carvedilol 6.25 mg tablets nationwide due to N-Nitroso Carvedilol I impurity above acceptable limits from manufacturing process deviations. No illnesses have been reported.

    Product
    CARVEDILOL — CARVEDILOL (CARVEDILOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0448-2025·2025-06-04

    Glenmark recalls Carvedilol tablets for genotoxic impurity above limits

    Glenmark Pharmaceuticals is recalling certain lots of Carvedilol 3.125mg tablets nationwide due to N-Nitroso Carvedilol I, a genotoxic impurity, exceeding FDA's acceptable intake limit.

    Product
    CARVEDILOL — CARVEDILOL (CARVEDILOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0450-2025·2025-06-04

    Carvedilol tablets recalled due to manufacturing deviation and nitrosamine impurity

    Glenmark Pharmaceuticals recalls Carvedilol 12.5 mg tablets nationwide due to presence of N-Nitroso Carvedilol I impurity above acceptable limits and manufacturing deviations. Affected patients should consult their physician.

    Product
    CARVEDILOL — CARVEDILOL (CARVEDILOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0452-2025·2025-06-04

    Theophylline Extended-Release Tablets Recalled for Dissolution Testing Failure

    Glenmark Pharmaceuticals is recalling Theophylline extended-release tablets nationwide due to failed dissolution testing. The tablets may not release the medication at the proper rate.

    Product
    THEOPHYLLINE — THEOPHYLLINE (THEOPHYLLINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0334-2025·2025-04-16

    Glenmark recalls Teriflunomide tablets over manufacturing quality deviations

    Glenmark Pharmaceuticals is recalling Teriflunomide tablets (14mg) due to manufacturing quality control violations. The recall affects products distributed nationwide.

    Product
    TERIFLUNOMIDE — TERIFLUNOMIDE (TERIFLUNOMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0347-2025·2025-04-16

    OTC Acetaminophen and Ibuprofen Tablets Recalled for Manufacturing Quality Deviations

    Glenmark Pharmaceuticals is recalling acetaminophen-ibuprofen tablets due to manufacturing quality deviations. No illnesses reported. Distributed nationwide via Amazon and Walmart.

    Product
    ACETAMINOPHEN, IBUPROFEN — ACETAMINOPHEN, IBUPROFEN (ACETAMINOPHEN, IBUPROFEN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0343-2025·2025-04-16

    FDA Recalls Lacosamide Tablets for Manufacturing Quality Deviations

    Glenmark Pharmaceuticals is recalling Lacosamide 150mg tablets nationwide due to manufacturing quality deviations. Consumers should contact their pharmacy or healthcare provider regarding their supply.

    Product
    LACOSAMIDE — LACOSAMIDE (LACOSAMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0327-2025·2025-04-16

    Fluphenazine Hydrochloride Drug Recall Due to Manufacturing Process Deviations

    Glenmark Pharmaceuticals is recalling Fluphenazine Hydrochloride Tablets 2.5mg nationwide due to manufacturing deviations. The company initiated this voluntary Class II recall after determining that production did not meet FDA standards.

    Product
    FLUPHENAZINE HYDROCHLORIDE — FLUPHENAZINE HYDROCHLORIDE (FLUPHENAZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0342-2025·2025-04-16

    Glenmark Diltiazem Extended-Release Capsules recalled for manufacturing deviations

    Glenmark Pharmaceuticals is voluntarily recalling Diltiazem Hydrochloride 120mg Extended-Release Capsules nationwide due to manufacturing process deviations. Consumers should verify lot numbers and consult their pharmacist.

    Product
    DILTIAZEM HYDROCHLORIDE — DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0322-2025·2025-04-16

    Frovatriptan Succinate tablets recalled for manufacturing process deviations

    Glenmark Pharmaceuticals is voluntarily recalling Frovatriptan Succinate 2.5mg tablets due to manufacturing process deviations. Affected lots were distributed nationwide; patients should contact their pharmacy or healthcare provider.

    Product
    FROVATRIPTAN SUCCINATE — FROVATRIPTAN SUCCINATE (FROVATRIPTAN SUCCINATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0337-2025·2025-04-16

    Lacosamide 50mg Tablets Recalled for Manufacturing Process Deviations

    Glenmark Pharmaceuticals is recalling Lacosamide 50mg tablets nationwide due to manufacturing process deviations. The affected lots (17240221 and 17240222) expire January 2026. No illnesses reported.

    Product
    LACOSAMIDE — LACOSAMIDE (LACOSAMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0351-2025·2025-04-16

    Drug Recall: Propafenone Hydrochloride Capsules Due to Manufacturing Deviations

    Glenmark Pharmaceuticals has voluntarily recalled Propafenone Hydrochloride Extended-Release Capsules (225mg, lot 17230819) due to manufacturing quality control deviations. The recall affects product distributed nationwide in the United States.

    Product
    PROPAFENONE HYDROCHLORIDE — PROPAFENONE HYDROCHLORIDE (PROPAFENONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide