Drugs & medicalClass III

Glenmark Pharmaceuticals Inc., USA recalls Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot…

Failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time point during long-term stability study.

Read the official notice →
Date
2025-06-18
Country
United States
Brand
Glenmark Pharmaceuticals
Product
Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2,…
Classification
Class III
Units
Nationwide USA and PR
Category
Drugs & medical
Source
FDA · Drug

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

More Glenmark Pharmaceuticals recalls

  1. 2025-08-20
  2. US
    Drugs & medicalClass II

    Glenmark Pharmaceuticals Inc., USA recalls Carvedilol Tablets, USP, 25 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2,…

    CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm

    FDA · DrugGlenmark Pharmaceuticals Inc., USANationwide within the USAOfficial notice →
  3. US
    Drugs & medicalClass II

    Glenmark Pharmaceuticals Inc., USA recalls Theophylline extended-release tablets 400mg, 100-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited,…

    Failed Dissolution Specifications: Failure results (above) were reported for the Dissolution (by UV) test for commercial annual stability at the long-term shelf life stability interval, wherein the dissolution results…

    FDA · DrugGlenmark Pharmaceuticals Inc., USAUSA nationwide.Official notice →
  4. US
    Drugs & medicalClass II

    Glenmark Pharmaceuticals Inc., USA recalls Carvedilol Tablets, USP, 12.5 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez,…

    CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.

    FDA · DrugGlenmark Pharmaceuticals Inc., USANationwide in the USAOfficial notice →
  5. 2025-06-04
  6. US
    Drugs & medicalClass II

    Glenmark Pharmaceuticals Inc., USA recalls Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Glenmark…

    OOS results reported for the Dissolution (by UV) test.

    FDA · DrugGlenmark Pharmaceuticals Inc., USANationwide in the USAOfficial notice →
  7. US
    Drugs & medicalClass II

    Glenmark Pharmaceuticals Inc., USA recalls Carvedilol Tablets USP 25 mg, 500 -Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for…

    CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit

    FDA · DrugGlenmark Pharmaceuticals Inc., USAU.S. NationwideOfficial notice →
  8. 2025-04-16
  9. US
All 43 Glenmark Pharmaceuticals recalls →

Other drugs & medical recalls in the United States

  1. 2025-06-18
  2. US
    Drugs & medicalClass III

    Macleods Pharmaceuticals Ltd recalls Levothyroxine Sodium Tablets, USP 112 mcg (0.112mg), 1000 tablets, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton,…

    Presence of a foreign substance: black hair found embedded in tablet.

    FDA · DrugMacleods Pharmaceuticals LtdNationwide in the USAOfficial notice →
  3. US
    Drugs & medicalClass II

    Ascend Laboratories, LLC recalls Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India,…

    Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin…

    FDA · DrugAscend Laboratories, LLCNationwide in the USA.Official notice →
  4. US
    Drugs & medicalClass I

    SAINI TRADE INC recalls ELECTRO BUZZ, Dietary Supplement, 10 capsules per box, Distributed By: Health Fixer, Tempe, AZ 85288, UPC B0DK68LF6J.

    Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared chloropretadalafil, propoxyphenylsildenafil, and sildenafil.

    FDA · DrugSAINI TRADE INCNationwideOfficial notice →
  5. US
  6. US
    Drugs & medicalClass II

    AvKARE recalls Celecoxib Capsules, 200 mg, 50 Capsules (5x10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-169-15

    Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsules

    FDA · DrugAvKARENationwide in the USAOfficial notice →
  7. US
    Drugs & medicalClass II

    Alembic Pharmaceuticals Limited recalls Celecoxib Capsules, 200 mg, 500-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division),…

    Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule

    FDA · DrugAlembic Pharmaceuticals LimitedDistributed Nationwide and in PROfficial notice →
See all drugs & medical recalls →