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

Read the official notice →
Date
2025-06-04
Country
United States
Brand
Glenmark Pharmaceuticals
Product
Carvedilol Tablets USP 25 mg, 500 -Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for Glenmark…
Classification
Class II
Units
U.S. Nationwide
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 Details may be shortened or out of date; the official notice is the authoritative source.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, 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 →
  3. 2025-06-18
  4. US
    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.

    FDA · DrugGlenmark Pharmaceuticals Inc., USANationwide USA and PROfficial 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. 2025-04-16
  8. US
  9. 2025-04-09
  10. US
    Drugs & medicalClass II

    Glenmark Pharmaceuticals Inc., USA recalls chlorproMAZINE Hydrochloride Tablets, USP 100 mg, Rx Only, 100 Tablets per bottle, Manufactured for: Glenmark Pharmaceuticals…

    CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit.

    FDA · DrugGlenmark Pharmaceuticals Inc., USANationwide in the USA and PROfficial notice →
  11. 2025-02-26
  12. US
    Drugs & medicalClass II

    Glenmark Pharmaceuticals Inc., USA recalls Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA,…

    CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

    FDA · DrugGlenmark Pharmaceuticals Inc., USANationwide within the U.SOfficial notice →
All 43 Glenmark Pharmaceuticals recalls →

Other drugs & medical recalls in the United States

  1. 2025-06-04
  2. US
    Drugs & medicalClass III

    Beckman Coulter Ireland, Inc. recalls Apo B Reagent, REF: OSR6143

    The product Value Assignment Sheet (VAS) is used in calibration of the device. An erroneous value was included in the VAS which has the potential to generate an incorrect APO B patient result which could exceed the…

    FDA · DeviceBeckman Coulter Ireland, Inc.Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA,…Official notice →
  3. US
    Drugs & medicalClass I

    EnShiShiXiangNiShangMaoYouXianGongSi recalls ENDURANCE BOOST WITH HORNY GOAT WEED, 500mg, 20 capsules per carton, VEPEMVA Nutrition Supplement....rgy and Endurance, UPC…

    Marketed without approved NDA/ANDA: The product has been found to be tainted with Sildenafil and Propoxyphenylsildenafil (a sildenafil analogue).

    FDA · DrugEnShiShiXiangNiShangMaoYouXianGongSiNationwide Via Amazon PlatformOfficial notice →
  4. 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 →
  5. US
    Drugs & medicalClass II

    Alembic Pharmaceuticals Limited recalls Bromfenac Ophthalmic Solution 0.09%, 1.7 mL bottle, Rx only, Sterile, Manufactured for: Alembic Pharmaceuticals, Inc.,…

    Failed Impurities/Degradation Specifications

    FDA · DrugAlembic Pharmaceuticals LimitedUS NationwideOfficial notice →
  6. 2025-05-28
  7. US
    Drugs & medicalClass II

    Advanced Bionics, LLC recalls HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607

    Due to incorrect the battery charger being packaged and distributed. Product labeling does not match the intended product as specified.

    FDA · DeviceAdvanced Bionics, LLCU.S.: AZ, FL, MI, SC, TN and TX. O.U.S.: N/AOfficial notice →
  8. US
    Drugs & medicalClass II

    Copan WASP recalls PhenoMATRIX

    AI-powered bacterial culture plate interpretation and workup software does not have Premarket Approval or pre-market notification (510(k)/de novo), so there is potential risk that the colony count and/or morphology…

    FDA · DeviceCopan WASPUS: Nationwide distribution in the states of UT, AR, CA, PA, MD, NC, IL, MA,…Official notice →
See all drugs & medical recalls →