Drugs & medicalClass II

Zydus Pharmaceuticals (USA) Inc recalls Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 68382-256-01) and b) 500 tablets (NDC 68382-256-05)…

Failed Dissolution Specifications

Read the official notice →
Date
2023-10-11
Country
United States
Brand
Zydus Pharmaceuticals
Product
Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 68382-256-01) and b) 500 tablets (NDC 68382-256-05) bottles,…
Classification
Class II
Units
Nationwide in the USA.
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 Details may be shortened or out of date; the official notice is the authoritative source.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 Zydus Pharmaceuticals recalls

  1. 2024-07-17
  2. US
    Drugs & medicalClass III

    Zydus Pharmaceuticals (USA) Inc recalls Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Vadodara, India,…

    Cross contamination with other products

    FDA · DrugZydus Pharmaceuticals (USA) IncNationwide in the USA and Puerto RicoOfficial notice →
  3. US
    Drugs & medicalClass III

    Zydus Pharmaceuticals (USA) Inc recalls Verapamil Hydrochloride Injection, USP 5 mg / 2mL(2.5 mg/mL), packaged as (a) 25x2 mL Single-Dose Vial per carton, Vial NDC:…

    Cross contamination with other products.

    FDA · DrugZydus Pharmaceuticals (USA) IncNationwide in the USAOfficial notice →
  4. 2024-06-12
  5. US
    Drugs & medicalClass III

    Zydus Pharmaceuticals (USA) Inc recalls Estradiol Transdermal System, USP (Twice-Weekly) 0.025mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad,…

    Failed Impurities/Degradation Specifications.

    FDA · DrugZydus Pharmaceuticals (USA) IncNationwide within the United StatesOfficial notice →
  6. 2023-11-15
  7. US
    Drugs & medicalClass II

    Zydus Pharmaceuticals (USA) Inc recalls Oxybutynin Chloride Extended-Release Tablet USP, 5 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd,…

    Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.

    FDA · DrugZydus Pharmaceuticals (USA) IncNationwide.Official notice →
  8. 2023-03-22
  9. US
    Drugs & medicalClass III

    Zydus Pharmaceuticals (USA) Inc recalls Colchicine Tablets, USP 0.6 mg, Rx Only, a) 30 tablets per bottle, NDC 16714-0039-01, b) 100 tablets per bottle, NDC…

    Failed Impurities/Degradation Specifications: An out-of-specification (OOS) result was observed during release testing of one lot for a related substance, i.e. Beta-lumicolchicine.

    FDA · DrugZydus Pharmaceuticals (USA) IncAZ, OH, MS.Official notice →
  10. 2022-08-24
  11. US
All 26 Zydus Pharmaceuticals recalls →

Other drugs & medical recalls in the United States

  1. 2023-10-11
  2. US
    Drugs & medicalClass II

    Eugia US LLC recalls Triamcinolone Acetonide Injectable Suspension, USP, 400 mg per 10 mL (40mg/mL), 10 mL Multiple Dose Vial, Rx Only, For Intramuscular or…

    Presence of Particulate Matter: A product complaint of a piece of glass was identified in a vial. The piece of glass appears to be roughly 1 cm x 0.5 cm inside the vial.

    FDA · DrugEugia US LLCNationwide in the USAOfficial notice →
  3. US
  4. US
    Drugs & medicalClass III

    Amerisource Health Services LLC recalls HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Health…

    Failed Impurities/Degradation Specifications: Out of Specification results in the repackaged product for impurities at the 12-month time point.

    FDA · DrugAmerisource Health Services LLCNationwide in the USAOfficial notice →
  5. US
    Drugs & medicalClass I

    Dr. Berne's Whole Health Products recalls Dr. Berne's MSM DROPS 5% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr. Berne's Whole Health Products, Tesuque, NM,…

    Non-Sterility

    FDA · DrugDr. Berne's Whole Health ProductsNationwide and UK, Canada, Italy, India, Australia, Germany, Switzerland,…Official notice →
  6. US
    Drugs & medicalClass II

    Dr. Berne's Whole Health Products recalls Dr. Berne's Organic Castor Oil Eye Drops, Net WT 30 mL/1 fl oz bottle, Distributed by: Dr. Berne's Whole Health Products,…

    CGMP Deviations

    FDA · DrugDr. Berne's Whole Health ProductsNationwide and UK, Canada, Italy, India, Australia, Germany, Switzerland,…Official notice →
  7. US
    Drugs & medicalClass II

    Central Admixture Pharmacy Services Inc recalls fentaNYL, 100 mcg/2 mL, (50 mcg/mL), 3 mL Syringe, Rx only, Repackaged by CAPS Inc., 7935 Dunbrook Road, Suite C, San…

    Lack of assurance of sterility:

    FDA · DrugCentral Admixture Pharmacy Services IncNationwide in the USAOfficial notice →
See all drugs & medical recalls →