Drugs & medicalClass II

Ascend Laboratories, LLC recalls Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx only, Manufactured by: Alken Laboratories Ltd., INDIA; Distributed by: Ascend…

Superpotent drug

Read the official notice →
Date
2025-09-24
Country
United States
Brand
Ascend Laboratories
Product
Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx only, Manufactured by: Alken Laboratories Ltd., INDIA; Distributed by: Ascend…
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 Details may be shortened or out of date; the official notice is the authoritative source.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. 2026-06-10
  2. US
    Drugs & medicalClass II

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

    Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications

    FDA · DrugAscend Laboratories, LLCU.S.A. NationwideOfficial notice →
  3. 2026-05-20
  4. US
  5. 2025-10-22
  6. US
  7. 2025-08-20
  8. US
    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

    FDA · DrugAscend Laboratories, LLCNationwide in the USAOfficial notice →
  9. 2025-07-23
  10. 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 →
  11. 2025-06-18
  12. 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 →
All 24 Ascend Laboratories recalls →

Other drugs & medical recalls in the United States

  1. 2025-09-24
  2. US
    Drugs & medicalClass II

    Sandoz Inc recalls Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL), Hazardous Drug, Rx Only, Sterile, 5mL Multiple Dose Vial, Manufactured in Austria by…

    cGMP deviations: Temperature excursion during transportation.

    FDA · DrugSandoz IncNationwide in the USAOfficial notice →
  3. US
    Drugs & medicalClass II

    Amerisource Health Services LLC recalls chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 (10x10) blisterpack per carton, Rx Only, Distributed by: American Health…

    Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any…

    FDA · DrugAmerisource Health Services LLCNationwide in the USAOfficial notice →
  4. US
  5. 2025-09-17
  6. US
    Drugs & medicalClass II

    Omnia Medical recalls TiBrid Stand Alone Intervertebral Body Fusion Device, TiBrid SA Angled Screwdrivers, Sizes 30 degree, 45 degree, and 60 degree angles.

    Failure of fusion system instruments in the field.

    FDA · DeviceOmnia MedicalUS Nationwide distribution in the states of AZ, CA, NJ, NV, OK & WA.Official notice →
  7. US
    Drugs & medicalClass II

    Orthofix U.S. LLC recalls PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP

    A 37 mm implant width intervertebral body fusion device has a labeling discrepancy with incorrect width of 33 mm stated on the outer label side flap and inner label side flap information box. The 37 mm width on the…

    FDA · DeviceOrthofix U.S. LLCUS Nationwide distribution in the states of CO, CA.Official notice →
  8. US
    Drugs & medicalClass II

    SEASPINE ORTHOPEDICS CORPORATION recalls Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System

    Inserter, used as part of a system with an intervertebral body fusion device, may contribute to difficulty disengaging the implant or improper implant positioning, which may may lead to prolonged surgery,…

    FDA · DeviceSEASPINE ORTHOPEDICS CORPORATIONWorldwide - US Nationwide distribution in the states of NV, TX, ID, MI, OH,…Official notice →
See all drugs & medical recalls →