The Recall Desk

FDA (Drugs) recall action 96474

Glenmark Pharmaceuticals Inc., USA recalled 39 products on 2025-04-16

The FDA (Drugs) publishes a recall like this one as 39 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 39 pages.

Products
39
Announced
2025-04-16
Critical
0
Units
—

Why these products were recalled

CGMP Deviations

The agency’s own wording, quoted from the enforcement report.

26–39 of 39

  • ModerateFDA (Drugs)··2025-04-16

    Prochlorperazine Maleate Tablets Recalled for Manufacturing Process Deviations

    Glenmark Pharmaceuticals is voluntarily recalling Prochlorperazine Maleate 10mg tablets (NDC# 68462-890-01) distributed nationwide due to manufacturing process deviations. No illnesses or injuries have been reported.

    Product
    Prochlorperazine Maleate Tablets, 10mg, 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-890-01
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2025-04-16

    Propafenone Hydrochloride Extended-Release Capsules Recalled for CGMP Deviations

    Glenmark Pharmaceuticals Inc. is recalling Propafenone Hydrochloride Extended-Release Capsules 325mg (Lot #17230767, expiring Mar-25) distributed nationwide due to current Good Manufacturing Practice (CGMP) deviations. Patients taking this medication should consult their physician before discontinuing use.

    Product
    PROPAFENONE HYDROCHLORIDE (PROPAFENONE HYDROCHLORIDE)
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2025-04-16

    Voriconazole Tablets 50mg Recalled Due to CGMP Deviations

    Glenmark Pharmaceuticals Inc. USA is recalling Voriconazole Tablets 50mg (Lot # 17231045, exp. date Apr-25) distributed nationwide due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing.

    Product
    VORICONAZOLE (VORICONAZOLE)
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2025-04-16

    Colesevelam Hydrochloride Tablets Recalled for CGMP Deviations

    Glenmark Pharmaceuticals Inc. is recalling Colesevelam Hydrochloride 625mg tablets nationwide due to CGMP deviations. The firm initiated this Class II voluntary recall; no illnesses or injuries have been reported.

    Product
    COLESEVELAM HYDROCHLORIDE (COLESEVELAM HYDROCHLORIDE)
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2025-04-16

    Pravastatin Sodium 20mg Tablets Recalled for CGMP Deviations

    Glenmark Pharmaceuticals Inc., USA is voluntarily recalling Pravastatin Sodium Tablets, USP, 20mg, 90-count bottles (Lot # 17230810, expiration Mar-26) nationwide due to manufacturing process deviations.

    Product
    PRAVASTATIN SODIUM (PRAVASTATIN SODIUM)
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2025-04-16

    Glenmark Pharmaceuticals Recalls Pravastatin Sodium Tablets 80mg

    Glenmark Pharmaceuticals Inc., USA is recalling specific lots of Pravastatin Sodium Tablets 80mg due to Current Good Manufacturing Practice (CGMP) deviations. The recall applies to affected lots distributed nationwide and was initiated voluntarily by the firm.

    Product
    PRAVASTATIN SODIUM (PRAVASTATIN SODIUM)
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··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)
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··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)
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2025-04-16

    Propafenone Hydrochloride Extended-Release Capsules Recalled for CGMP Deviations

    Glenmark Pharmaceuticals Inc., USA is recalling Propafenone Hydrochloride Extended-Release Capsules 225mg due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects lot #17230819 with expiration date March 2025, distributed nationwide.

    Product
    PROPAFENONE HYDROCHLORIDE (PROPAFENONE HYDROCHLORIDE)
    Category
    Distribution
    0 states
Glenmark Pharmaceuticals Inc., USA recalled 39 products on 2025-04-16 · The Recall Desk