The Recall Desk

Manufacturer

Glenmark Pharmaceuticals Inc., USA

123 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 123

  • Severity pendingFDA (Drugs)·D-0588-2026·2026-06-24

    ALYACEN 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL)

    Pending LLM rewrite. Source: FDA_DRUG D-0588-2026.

    Product
    ALYACEN 1/35 — ALYACEN 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • Severity pendingFDA (Drugs)·D-0246-2026·2026-01-07

    ONDANSETRON (ONDANSETRON)

    Pending LLM rewrite. Source: FDA_DRUG D-0246-2026.

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

    NEBIVOLOL (NEBIVOLOL HYDROCHLORIDE)

    Pending LLM rewrite. Source: FDA_DRUG D-0222-2026.

    Product
    NEBIVOLOL — NEBIVOLOL (NEBIVOLOL HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • Severity pendingFDA (Drugs)·D-0662-2025·2025-10-01

    AZELAIC ACID (AZELAIC ACID)

    Pending LLM rewrite. Source: FDA_DRUG D-0662-2025.

    Product
    AZELAIC ACID — AZELAIC ACID (AZELAIC ACID)
    Category
    Drug
    Distribution
    Distributed nationwide
  • Severity pendingFDA (Drugs)·D-0587-2025·2025-08-20

    CARVEDILOL (CARVEDILOL)

    Pending LLM rewrite. Source: FDA_DRUG D-0587-2025.

    Product
    CARVEDILOL — CARVEDILOL (CARVEDILOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • Severity pendingFDA (Drugs)·D-0577-2025·2025-08-20

    CARVEDILOL (CARVEDILOL)

    Pending LLM rewrite. Source: FDA_DRUG D-0577-2025.

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

    CARVEDILOL (CARVEDILOL)

    Pending LLM rewrite. Source: FDA_DRUG D-0578-2025.

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

    CARVEDILOL (CARVEDILOL)

    Pending LLM rewrite. Source: FDA_DRUG D-0579-2025.

    Product
    CARVEDILOL — CARVEDILOL (CARVEDILOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • Severity pendingFDA (Drugs)·D-0583-2025·2025-08-20

    THEOPHYLLINE (THEOPHYLLINE)

    Pending LLM rewrite. Source: FDA_DRUG D-0583-2025.

    Product
    THEOPHYLLINE — THEOPHYLLINE (THEOPHYLLINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • Severity pendingFDA (Drugs)·D-0588-2025·2025-08-20

    CARVEDILOL (CARVEDILOL)

    Pending LLM rewrite. Source: FDA_DRUG D-0588-2025.

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

    Ezetimibe and Simvastatin Tablets Recalled for Failed Impurity Specifications

    Glenmark Pharmaceuticals Inc., USA is recalling Ezetimibe and Simvastatin Tablets (10mg/40mg) due to out-of-specification results for related substances in a stability study. The recall affects approximately 6,759 bottles distributed nationwide.

    Product
    EZETIMIBE AND SIMVASTATIN — EZETIMIBE AND SIMVASTATIN (EZETIMIBE AND SIMVASTATIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0448-2025·2025-06-04

    Carvedilol Tablets Recalled Due to N-Nitroso Impurity

    Glenmark Pharmaceuticals Inc., USA is recalling Carvedilol Tablets USP 3.125mg due to the presence of N-Nitroso Carvedilol I impurity above the recommended acceptable intake limit. The recall affects 100-count and 500-count bottles distributed nationwide.

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

    Carvedilol Tablets 6.25 mg Recalled for N-Nitroso Impurity

    Glenmark Pharmaceuticals Inc., USA is recalling Carvedilol Tablets USP 6.25 mg due to the presence of N-Nitroso Carvedilol I impurity above the recommended acceptable intake limit. The recall affects 100-count and 500-count bottles distributed nationwide.

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

    Carvedilol Tablets 12.5 mg Recalled for Impurity Above Limit

    Glenmark Pharmaceuticals Inc., USA is recalling Carvedilol Tablets USP 12.5 mg due to the presence of N-Nitroso Carvedilol I impurity above the recommended acceptable intake limit, resulting from current Good Manufacturing Practice (CGMP) deviations.

    Product
    CARVEDILOL — CARVEDILOL (CARVEDILOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0451-2025·2025-06-04

    Carvedilol Tablets 25 mg Recalled Due to Impurity Above Acceptable Limit

    Glenmark Pharmaceuticals is recalling Carvedilol Tablets USP 25 mg nationwide due to the presence of N-Nitroso Carvedilol I impurity above the recommended acceptable intake limit, resulting from CGMP deviations.

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

    Theophylline Extended-Release Tablets recalled for dissolution test failure

    Glenmark Pharmaceuticals is recalling Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, due to out-of-specification results on dissolution testing. The recall affects 8,520 bottles distributed nationwide.

    Product
    THEOPHYLLINE — THEOPHYLLINE (THEOPHYLLINE)
    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
  • ModerateFDA (Drugs)·D-0352-2025·2025-04-16

    Propafenone Hydrochloride Extended-Release Capsules Recalled for CGMP Deviations

    Glenmark Pharmaceuticals is voluntarily recalling Propafenone Hydrochloride Extended-Release Capsules 325mg (Lot #17230767, exp. Mar-25) distributed nationwide due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    PROPAFENONE HYDROCHLORIDE — PROPAFENONE HYDROCHLORIDE (PROPAFENONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0334-2025·2025-04-16

    Teriflunomide Tablets 14mg Recalled for CGMP Manufacturing Deviations

    Glenmark Pharmaceuticals Inc. is voluntarily recalling Teriflunomide 14mg tablets (Lot #17232462, expiring Nov-25) distributed nationwide due to current good manufacturing practice (CGMP) deviations discovered during production.

    Product
    TERIFLUNOMIDE — TERIFLUNOMIDE (TERIFLUNOMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0335-2025·2025-04-16

    Drug Recall: Ranolazine Extended-Release Tablets Due to Manufacturing Deviations

    Glenmark Pharmaceuticals is recalling Ranolazine Extended-Release 1000mg tablets (Lot 17240040) nationwide due to manufacturing deviations. This is a voluntary, firm-initiated recall.

    Product
    RANOLAZINE — RANOLAZINE (RANOLAZINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0332-2025·2025-04-16

    Saxagliptin 5mg Tablets Recalled for Manufacturing Practice Deviations

    Glenmark Pharmaceuticals is voluntarily recalling Saxagliptin 5mg tablets nationwide due to CGMP deviations. Affected lot numbers are 17232460 and 17241194.

    Product
    SAXAGLIPTIN — SAXAGLIPTIN (SAXAGLIPTIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0339-2025·2025-04-16

    Rosuvastatin Calcium Tablets Recalled Nationwide Due to Manufacturing Deviations

    Glenmark Pharmaceuticals is voluntarily recalling Rosuvastatin Calcium 40mg tablets nationwide due to manufacturing practice deviations. The recall affects specific lot numbers expiring February through June 2026.

    Product
    ROSUVASTATIN CALCIUM — ROSUVASTATIN CALCIUM (ROSUVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide