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.

101–122 of 122

  • ModerateFDA (Drugs)·D-0112-2024·2023-11-29

    Prescription esomeprazole magnesium capsules recalled for failed impurity specifications

    Glenmark Pharmaceuticals recalled esomeprazole magnesium 20mg capsules nationwide due to out-of-specification organic impurities detected during stability testing. No illnesses have been reported.

    Product
    ESOMEPRAZOLE MAGNESIUM — ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0095-2024·2023-11-15

    FDA Recalls Deferasirox Tablets for Failed Dissolution Specifications

    Glenmark Pharmaceuticals is recalling Deferasirox 500mg tablets nationwide due to failed dissolution specifications affecting approximately 5,856 bottles across multiple lots.

    Product
    DEFERASIROX — DEFERASIROX (DEFERASIROX)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0092-2024·2023-11-15

    Ranolazine Extended-Release Tablets Recalled for Failed Dissolution Specifications

    Glenmark Pharmaceuticals is recalling 16,944 bottles of Ranolazine 500mg tablets nationwide due to failed dissolution specifications. Tablets may not dissolve properly, potentially affecting drug efficacy.

    Product
    RANOLAZINE — RANOLAZINE (RANOLAZINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0085-2024·2023-11-08

    Bisoprolol Fumarate and Hydrochlorothiazide Tablets Recalled for Failed Quality Specifications

    Glenmark Pharmaceuticals is recalling Bisoprolol Fumarate and Hydrochlorothiazide Tablets due to failed impurities and degradation specifications. The recall affects 480 bottles distributed nationwide.

    Product
    BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE — BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1095-2023·2023-08-30

    Prescription Drug Trandolapril and Verapamil Tablets Recalled for Subpotency

    Glenmark Pharmaceuticals is recalling Trandolapril and Verapamil Extended-Release Tablets because they are subpotent—they do not contain their full specified amount of active ingredient. The issue was found during three-month stability testing.

    Product
    TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE — TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE (TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1306-2022·2022-08-17

    Glenmark Pharmaceuticals Recalls Telmisartan/Hydrochlorothiazide Due to Defective Blister Packs

    Glenmark Pharmaceuticals Inc., USA is recalling specific lots of Telmisartan and Hydrochlorothiazide tablets due to complaints of defective blister packs that are difficult to open and cause tablets to break during removal.

    Product
    TELMISARTAN AND HYDROCHLOROTHIAZIDE — TELMISARTAN AND HYDROCHLOROTHIAZIDE (TELMISARTAN AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1305-2022·2022-08-17

    Prescription Drug Recall: Telmisartan-Hydrochlorothiazide Tablets Due to Defective Packaging

    Glenmark Pharmaceuticals recalls 72,288 units of Telmisartan-Hydrochlorothiazide 80/25 mg tablets nationwide due to defective blister packaging that is difficult to open and causes tablets to break.

    Product
    TELMISARTAN AND HYDROCHLOROTHIAZIDE — TELMISARTAN AND HYDROCHLOROTHIAZIDE (TELMISARTAN AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1304-2022·2022-08-10

    Tacrolimus Ointment Recalled for Defective Containers That Split

    Glenmark Pharmaceuticals is recalling Tacrolimus Ointment 0.1% because tubes may split at the side seam. The recall affects over 654,000 units distributed nationwide.

    Product
    TACROLIMUS — TACROLIMUS (TACROLIMUS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1282-2022·2022-07-27

    Aspirin-Dipyridamole Capsules Recalled for Capsule Breakage Defect

    Glenmark Pharmaceuticals is recalling Aspirin and Extended-Release Dipyridamole Capsules due to capsule breakage defects. Approximately 168,936 bottles were distributed nationwide.

    Product
    ASPRIN AND EXTENDED-RELEASE DIPYRIDAMOLE — ASPRIN AND EXTENDED-RELEASE DIPYRIDAMOLE (ASPRIN AND EXTENDED-RELEASE DIPYRIDAMOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1173-2022·2022-07-13

    Mometasone Furoate Topical Solution Recalled Due to Defective Containers

    Glenmark Pharmaceuticals is recalling Mometasone Furoate Topical Solution USP 0.1% due to defective containers. Approximately 98,307 packs were distributed nationwide.

    Product
    MOMETASONE FUROATE — MOMETASONE FUROATE (MOMETASONE FUROATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1171-2022·2022-07-06

    Desmopressin Acetate Tablets recalled for manufacturing process deviations

    Glenmark Pharmaceuticals voluntarily recalls 36 bottles of Desmopressin Acetate Tablets (0.2 mg) due to manufacturing process deviations. The recall affected one distributor in Texas.

    Product
    Desmopressin Acetate Tablets, 0.2 mg, 100-count bottles, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403513, India, NDC 16714-884-01
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0792-2022·2022-05-04

    Drug Recall: Zonisamide Capsules Due to Manufacturing Deviations

    Glenmark Pharmaceuticals is recalling 12,003 bottles of Zonisamide 50 mg capsules nationwide due to manufacturing deviations.

    Product
    ZONISAMIDE — ZONISAMIDE (ZONISAMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0820-2021·2021-09-29

    Fulvestrant Injection Recall: Lack of Sterility Assurance

    Glenmark Pharmaceuticals is recalling Fulvestrant Injection 250 mg/5 mL due to lack of assurance of sterility. The affected product was distributed nationwide in 28,658 cartons across multiple lots.

    Product
    FULVESTRANT — FULVESTRANT (FULVESTRANT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0827-2021·2021-09-29

    Arformoterol Tartrate Inhalation Solution Recall Due to Sterility Assurance

    Glenmark Pharmaceuticals is recalling Arformoterol Tartrate Inhalation Solution 15 mcg/2 mL nationwide because the manufacturer lacks assurance of sterility for affected lots.

    Product
    Arformoterol Tartrate Inhalation Solution 15 mcg*/2 mL For Oral Inhalation Only Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 a) 60x2 mL Sterile Unit-Dose Vials NDC 68462-833-65;
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0826-2021·2021-09-29

    Zonisamide Capsules Recalled by Glenmark Due to CGMP Deviations

    Glenmark Pharmaceuticals Inc., USA is voluntarily recalling Zonisamide Capsules USP 100 mg nationwide due to CGMP (Current Good Manufacturing Practice) deviations. The recall affects multiple lot numbers distributed from August 2021.

    Product
    ZONISAMIDE — ZONISAMIDE (ZONISAMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0825-2021·2021-09-29

    Zonisamide Capsules Recalled for Manufacturing Deviations

    Glenmark Pharmaceuticals is recalling Zonisamide Capsules 50 mg nationwide due to manufacturing deviations. The recall affects approximately 15,936 bottles across multiple lots with expiration dates in May 2022.

    Product
    ZONISAMIDE — ZONISAMIDE (ZONISAMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0821-2021·2021-09-29

    Glenmark Naproxen Sodium Tablets recalled for CGMP deviations

    Glenmark Pharmaceuticals is recalling 9,552 bottles of Naproxen Sodium Tablets USP 275 mg nationwide due to CGMP (current Good Manufacturing Practice) deviations identified at the manufacturing facility.

    Product
    NAPROXEN SODIUM — NAPROXEN SODIUM (NAPROXEN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0824-2021·2021-09-29

    Chlorzoxazone 750 mg Tablets Recalled Due to CGMP Deviations

    Glenmark Pharmaceuticals is recalling Chlorzoxazone 750 mg tablets nationwide due to current good manufacturing practice (CGMP) deviations. The voluntary recall affects 4,752 bottles with five affected lot numbers.

    Product
    Chlorzoxazone Tablets USP 750 mg 100 Tablets Rx Only NDC 68462-725-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0822-2021·2021-09-29

    Glenmark Naproxen Sodium 550 mg Tablets Recalled for CGMP Deviations

    Glenmark Pharmaceuticals is recalling specific lots of Naproxen Sodium 550 mg tablets nationwide due to manufacturing deviations. The firm initiated the voluntary recall on August 27, 2021.

    Product
    NAPROXEN SODIUM — NAPROXEN SODIUM (NAPROXEN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0823-2021·2021-09-29

    Drug Recall: Chlorzoxazone Tablets Due to Manufacturing Deviations

    Glenmark Pharmaceuticals is recalling 1,800 bottles of Chlorzoxazone Tablets USP 375 mg nationwide due to current Good Manufacturing Practice (CGMP) deviations. The recall was initiated on August 27, 2021.

    Product
    Chlorzoxazone Tablets USP 375 mg 100 Tablets Rx Only NDC 68462-724-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430
    Category
    Drug
    Distribution
    Distributed nationwide