The Recall Desk

Manufacturer

Glenmark Pharmaceuticals Inc., USA

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

What the numbers show

Total
141
Critical
1
Severe
14
Most recent
2026-08-05

Of the 141 recalls from Glenmark Pharmaceuticals Inc., USA we have scored against our rubric, 1 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 14 (10%) are Severe.

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 141

  • ModerateFDA (Drugs)·D-0731-2026·2026-08-05

    Azelaic Acid Gel 15% Recalled Over Grainy, Gritty, or Sandy Texture

    Glenmark Pharmaceuticals is recalling azelaic acid gel 15% after receiving complaints that the product felt grainy, gritty, or sandy. The nationwide recall covers specific lots with expiration dates from February through April 2028.

    Product
    AZELAIC ACID — AZELAIC ACID (AZELAIC ACID)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0588-2026·2026-06-24

    Alyacen 7/7/7 birth control tablets failed total impurities specification

    Alyacen 7/7/7 norethindrone and ethinyl estradiol tablets are being recalled because of out-of-specification results for total impurities.

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

    Ondansetron tablets recalled because blister packs are not fully sealed

    Glenmark Pharmaceuticals is recalling 96,948 packs of Ondansetron Orally Disintegrating Tablets, 4mg, because the blister packs are not fully sealed and tablets are falling out.

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

    Frozen chopped methi recalled after testing positive for Salmonella

    Chetak New York is recalling Deep-brand frozen chopped methi after the product tested positive for Salmonella. The FDA has classified the action as Class I.

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

    Bisoprolol and hydrochlorothiazide tablets recalled over traces of another drug

    Glenmark Pharmaceuticals is recalling 11,136 bottles of Bisoprolol Fumarate and Hydrochlorothiazide Tablets after reserve sample testing showed traces of ezetimibe.

    Product
    BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE — BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0662-2025·2025-10-01

    Azelaic acid gel recalled after complaints of gritty texture in tubes

    Glenmark Azelaic Acid Gel, 15%, 50 gram tubes from batch 19252524, is recalled nationwide after market complaints of a gritty or grainy texture. 13,824 tubes are affected.

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

    Carvedilol 3.125 mg tablets recalled for nitrosamine impurity above intake limit

    Glenmark Carvedilol Tablets USP, 3.125 mg, in 100- and 500-count bottles are recalled nationwide because N-Nitroso Carvedilol I impurity exceeded the current Acceptable Intake level. 44,328 bottles are affected.

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

    Glenmark carvedilol 12.5 mg tablets exceed the nitrosamine impurity limit

    Carvedilol Tablets USP 12.5 mg from Glenmark are being recalled because N-Nitroso Carvedilol Impurity-1 was observed above the FDA-recommended limit of not more than 4.0 ppm. 17,496 bottles affected.

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

    Glenmark carvedilol 25 mg tablets exceed the acceptable nitrosamine intake level

    Carvedilol Tablets USP 25 mg from Glenmark are being recalled because of the presence of a nitrosamine, N-Nitroso Carvedilol I, above the current Acceptable Intake Level. 4,800 bottles affected.

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

    Carvedilol 12.5 mg tablets recalled over nitrosamine above acceptable intake level

    Glenmark Carvedilol Tablets USP, 12.5 mg, lot 19243202, are recalled nationwide because N-Nitroso Carvedilol I impurity was found above the current Acceptable Intake level. 6,432 bottles are affected.

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

    Carvedilol 25 mg tablets recalled over nitrosamine impurity above FDA limit

    Glenmark Carvedilol Tablets USP, 25 mg, in 500-tablet cartons are recalled nationwide after N-Nitroso Carvedilol Impurity-1 was found above the FDA-recommended limit. 14,976 bottles are affected.

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

    Theophylline extended-release tablets failed dissolution at long-term stability testing

    Theophylline extended-release tablets 400 mg from Glenmark are being recalled because dissolution results at the long-term shelf life stability interval did not comply with L3 stage criteria. 22,656 bottles affected.

    Product
    THEOPHYLLINE — THEOPHYLLINE (THEOPHYLLINE)
    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-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-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
  • ModerateFDA (Drugs)·D-0348-2025·2025-04-16

    Cetirizine HCL tablets recalled for manufacturing process deviations

    Glenmark Pharmaceuticals is voluntarily recalling Cetirizine HCL 10mg tablets distributed nationwide. The recall was initiated due to Current Good Manufacturing Practice deviations.

    Product
    CETIRIZINE HCL — CETIRIZINE HCL (CETIRIZINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0321-2025·2025-04-16

    Lacosamide Tablets 200mg Recalled Due to CGMP Deviations

    Glenmark Pharmaceuticals is recalling Lacosamide Tablets 200mg nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall is voluntary and affects specific lot numbers with expiration dates ranging from April 2025 to April 2026.

    Product
    LACOSAMIDE — LACOSAMIDE (LACOSAMIDE)
    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-0331-2025·2025-04-16

    Nitroglycerin Sublingual Tablets Recalled for CGMP Deviations

    Glenmark Pharmaceuticals Inc. is recalling specific lots of Nitroglycerin 0.3MG sublingual tablets distributed nationwide due to Current Good Manufacturing Practice (CGMP) deviations. Patients should consult their healthcare provider.

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

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Glenmark Pharmaceuticals

Indian multinational pharmaceutical company

Country
India
Founded
1977

Official website

Source: Wikidata (Q5568612), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.