Drugs & medicalClass II

Ascend Laboratories, LLC recalls Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA;…

Failed Dissolution Specifications: low dissolution results

Read the official notice →
Date
2025-08-20
Country
United States
Brand
Ascend Laboratories
Product
Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA;…
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 Details may be shortened or out of date; the official notice is the authoritative source.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 Ascend Laboratories recalls

  1. 2026-05-20
  2. US
  3. 2025-10-22
  4. US
  5. 2025-09-24
  6. US
  7. 2025-07-23
  8. US
    Drugs & medicalClass II

    Ascend Laboratories, LLC recalls Rizatriptan Benzoate Tablets, USP, 10 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA,…

    CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.

    FDA · DrugAscend Laboratories, LLCUS Nationwide.Official notice →
  9. 2025-06-18
  10. 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 →
  11. 2024-12-18
  12. US
    Drugs & medicalClass II

    Ascend Laboratories, LLC recalls Dabigatran Etexilate, 150mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend…

    CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit

    FDA · DrugAscend Laboratories, LLCNationwide within the United StatesOfficial notice →
All 24 Ascend Laboratories recalls →

Other drugs & medical recalls in the United States

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

    Westminster Pharmaceuticals LLC recalls Metoprolol Tartrate Tablets, USP, 100 mg, 1000 Tablets, Rx Only, Manufactured by: Renata PLC (General Plant -2), Noyapara, Bhawal…

    CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.

    FDA · DrugWestminster Pharmaceuticals LLCNationwide in the USA.Official notice →
  3. US
    Drugs & medicalClass II

    Breckenridge Pharmaceutical, Inc. recalls Duloxetine Delayed-Release Capsules, USP, 60 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical…

    CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.

    FDA · DrugBreckenridge Pharmaceutical, Inc.NJ, AZ, INOfficial 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. US
  6. 2025-08-13
  7. US
    Drugs & medicalClass II

    Stryker Corporation recalls Stryker SmartPump Tourniquet, disposable sterile (single use) DISP 18X3,1BLA,1PRT QUICK / 5921-018-135; DISP 18X3,1BLA,2PRT QUICK /…

    Tourniquet cuff flange may become detached from the bladder. If leak occurs during the procedure, there may be risk of hemorrhage, resulting in blood loss greater than expected. Other serious risks include cerebral…

    FDA · DeviceStryker CorporationDomestic US distribution nationwide. International distribution to Australia…Official notice →
  8. US
    Drugs & medicalClass II

    Intersurgical Inc recalls One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080.

    Potential contamination with small burrs, which if detach could be inhaled and result in potential complications such as airway obstruction, tissue irritation, inflammation and infection.

    FDA · DeviceIntersurgical IncUS distribution to AZ, CA, CT, FL, FL, HI, MA, MI, OH, UT, VA.Official notice →
See all drugs & medical recalls →