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.

76–100 of 122

  • HighFDA (Drugs)·D-0095-2025·2024-12-11

    Diltiazem Hydrochloride Extended-Release Capsules Recalled for Manufacturing Impurity

    Glenmark Pharmaceuticals is recalling 25,584 bottles of Diltiazem Hydrochloride Extended-Release Capsules 120 mg nationwide due to a manufacturing impurity above FDA-recommended limits. The affected medication was distributed throughout the United States.

    Product
    DILTIAZEM HYDROCHLORIDE — DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0097-2025·2024-12-11

    Diltiazem extended-release capsules recalled for manufacturing impurity

    Glenmark Pharmaceuticals is recalling 4,704 bottles of Diltiazem Hydrochloride extended-release capsules 90mg due to manufacturing contamination with an impurity above FDA limits. Two lot numbers distributed nationwide are affected.

    Product
    DILTIAZEM HYDROCHLORIDE — DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0096-2025·2024-12-11

    Prescription Drug Diltiazem Hydrochloride Recalled for Manufacturing Impurity

    Glenmark Pharmaceuticals is recalling 5,232 bottles of Diltiazem Hydrochloride Extended-Release Capsules nationwide due to an impurity that exceeds FDA safety limits. Patients currently taking this medication should contact their pharmacist or doctor.

    Product
    DILTIAZEM HYDROCHLORIDE — DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0094-2025·2024-12-11

    Diltiazem Hydrochloride Capsules Recalled Due to N-Nitroso Impurity Above Limits

    Glenmark Pharmaceuticals recalls Diltiazem Hydrochloride extended-release capsules due to presence of N-nitroso-desmethyl-diltiazem impurity above FDA recommended limits. The recall affects 12,864 bottles distributed nationwide.

    Product
    DILTIAZEM HYDROCHLORIDE — DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0093-2025·2024-12-11

    Diltiazem Hydrochloride Capsules Recalled Due to Manufacturing Impurity

    Glenmark Pharmaceuticals is recalling Diltiazem Hydrochloride Extended-Release Capsules (60 mg) due to presence of N-nitroso-Desmethyl-Diltiazem impurity exceeding FDA limits. Approximately 34,848 bottles nationwide are affected.

    Product
    DILTIAZEM HYDROCHLORIDE — DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0098-2025·2024-12-11

    Diltiazem Hydrochloride Capsules Recalled Due to Nitrosamine Impurity

    Glenmark Pharmaceuticals is recalling Diltiazem Hydrochloride capsules because they contain a chemical impurity above safe limits. About 7,296 bottles were distributed nationwide.

    Product
    DILTIAZEM HYDROCHLORIDE — DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0002-2025·2024-10-09

    Ciclopirox Gel 0.77% Tubes Recalled Due to Broken Seals

    Glenmark Pharmaceuticals is recalling Ciclopirox Gel 0.77% tubes nationwide due to broken seals. The recall affects 11,568 tubes; no illnesses or injuries have been reported.

    Product
    Ciclopirox Gel 0.77%, For Dermatologic Use Only, Not for Use in Eyes, Rx Only, a) 30 gm Tube, NDC 68462-0455-35; b) 45 gm Tube, NDC 68462-0455-47; c) 100 gm Tube, NDC 68462-0455-94, Manufactured by: Glenmark Pharmaceuticals, Ltd., Colvale-Bardez, Goa 403513, India, Manufactured f
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0006-2025·2024-10-09

    Ryaltris Nasal Spray Recalled for Clogged Dip Tube

    Ryaltris nasal spray is being recalled because the dip tube is clogged, preventing the spray from functioning. The recall affects 45,504 bottles distributed nationwide.

    Product
    RYALTRIS — RYALTRIS (OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0660-2024·2024-10-02

    Mupirocin Antibiotic Ointment Recalled Nationwide Due to Subpotency

    Glenmark Pharmaceuticals recalls Mupirocin Ointment nationwide due to subpotency, meaning some lots contain less active ingredient than specified. Affected customers should contact their pharmacy or prescriber.

    Product
    MUPIROCIN — MUPIROCIN (MUPIROCIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0621-2024·2024-08-07

    Prescription azelaic acid gel recalled for manufacturing process deviations

    Glenmark Pharmaceuticals recalls azelaic acid gel 15% nationwide due to manufacturing process deviations. Patients should consult their healthcare provider about their prescription.

    Product
    AZELAIC ACID — AZELAIC ACID (AZELAIC ACID)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0604-2024·2024-07-24

    Potassium Chloride Extended-Release Capsules Recalled for Failed Dissolution Specifications

    Glenmark Pharmaceuticals is recalling potassium chloride extended-release capsules (750 mg) nationwide due to failed dissolution specifications. Affected patients should contact their healthcare provider before making any changes to their medication.

    Product
    POTASSIUM CHLORIDE — POTASSIUM CHLORIDE (POTASSIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0612-2024·2024-07-24

    Pravastatin Sodium Tablets Recalled for Failed Dissolution Specifications

    Glenmark Pharmaceuticals is recalling Pravastatin Sodium 80mg tablets nationwide due to failed dissolution specifications. The affected tablets may not dissolve properly, potentially affecting drug absorption.

    Product
    PRAVASTATIN SODIUM — PRAVASTATIN SODIUM (PRAVASTATIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0607-2024·2024-07-24

    Prescription Potassium Chloride Extended-Release Capsules Recalled for Manufacturing Deviations

    Glenmark Pharmaceuticals is recalling Potassium Chloride Extended-Release Capsules nationwide due to manufacturing practice deviations. The voluntary recall affects multiple lot numbers, with no reported illnesses or injuries.

    Product
    POTASSIUM CHLORIDE — POTASSIUM CHLORIDE (POTASSIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0535-2024·2024-06-12

    FDA Recalls Rizatriptan Benzoate Tablets for Manufacturing Impurity

    Glenmark Pharmaceuticals is recalling Rizatriptan Benzoate 10mg tablets nationwide due to N-nitroso impurity levels exceeding FDA acceptable limits, affecting 13,296 cartons.

    Product
    RIZATRIPTAN BENZOATE — RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0533-2024·2024-06-12

    Rizatriptan Benzoate Tablets Recalled for Excessive N-Nitroso Impurity

    Glenmark Pharmaceuticals recalls certain Rizatriptan Benzoate tablets due to N-Nitroso Desmethyl Rizatriptan impurity levels exceeding FDA acceptable limits. The affected lots were distributed nationwide.

    Product
    RIZATRIPTAN BENZOATE — RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0532-2024·2024-06-12

    Prescription Rizatriptan Benzoate Tablets Recalled for Chemical Impurity

    Glenmark Pharmaceuticals recalls Rizatriptan Benzoate 5mg tablets due to excess N-Nitroso Desmethyl Rizatriptan impurity. The nationwide recall affects 3,480 cartons with lots 19233788 and 19224445.

    Product
    RIZATRIPTAN BENZOATE — RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0534-2024·2024-06-12

    Prescription migraine drug recalled for manufacturing impurity above FDA limit

    Glenmark Pharmaceuticals is recalling Rizatriptan Benzoate tablets for exceeding FDA acceptable limits of N-Nitroso Desmethyl Rizatriptan impurity. The recall affects 2,400 cartons distributed nationwide.

    Product
    RIZATRIPTAN BENZOATE — RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0472-2024·2024-05-01

    Prescription Drug Recall: Diltiazem Extended-Release Capsules Fail Dissolution Test

    Glenmark Pharmaceuticals is recalling 3,264 bottles of Diltiazem Hydrochloride Extended-Release Capsules nationwide due to failure to meet dissolution specifications. The affected lot may not release the medication properly in the body.

    Product
    DILTIAZEM HYDROCHLORIDE — DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0430-2024·2024-04-10

    Diltiazem Hydrochloride Capsules Recalled Due to Failed Dissolution Specifications

    Glenmark Pharmaceuticals is recalling 6,528 bottles of Diltiazem Hydrochloride Extended-Release Capsules nationwide because dissolution testing found the product does not meet specifications. The FDA has classified this as a Class II recall.

    Product
    DILTIAZEM HYDROCHLORIDE — DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0259-2024·2024-01-31

    Fluocinolone Acetonide Ear Drops Recalled Due to Failed Specification

    Glenmark Pharmaceuticals is recalling Fluocinolone Acetonide Oil 0.01% ear drops due to failed excipient specifications. The affected lots nationwide do not meet required quality standards for isopropyl alcohol content.

    Product
    FLUOCINOLONE ACETONIDE — FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0124-2024·2023-12-06

    Prescription Naproxen 250mg tablets recalled for labeling mix-up with indomethacin

    Glenmark Pharmaceuticals is recalling Naproxen Sodium 250mg tablets nationwide due to a labeling mix-up where Indomethacin bottles may be labeled as Naproxen. Patients could receive the wrong medication.

    Product
    NAPROXEN SODIUM — NAPROXEN SODIUM (NAPROXEN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0123-2024·2023-12-06

    Prescription Drug Indomethacin Recalled Due to Label Mix-Up

    Glenmark Pharmaceuticals is recalling 37,200 bottles of Indomethacin 25mg capsules distributed nationwide because the bottles may be labeled as Naproxen instead. This labeling error could cause medication confusion.

    Product
    INDOMETHACIN — INDOMETHACIN (INDOMETHACIN)
    Category
    Drug
    Distribution
    Distributed nationwide