Drugs & medicalClass II

Ascend Laboratories, LLC recalls Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd.,…

Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis

Read the official notice →
Date
2026-06-17
Country
United States
Brand
Ascend Laboratories
Product
Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd.,…
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 Details may be shortened or out of date; the official notice is the authoritative source.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

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    Ascend Laboratories, LLC recalls Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further packaged in a carton, Rx only, Manufactured by: Alkem…

    Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability

    FDA · DrugAscend Laboratories, LLCUSA NationwideOfficial notice →
  3. 2026-07-29
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    Ascend Laboratories, LLC recalls Dabigatran etexilate Capsules, 150 mg, 20-count carton (2x10), Rx only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed…

    Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.

    FDA · DrugAscend Laboratories, LLCUSA NationwideOfficial notice →
  5. US
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    Ascend Laboratories, LLC recalls Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd.,…

    Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications

    FDA · DrugAscend Laboratories, LLCNationwide in the USAOfficial notice →
  6. 2026-06-10
  7. 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 →
  8. 2026-05-20
  9. US
  10. 2025-10-22
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All 24 Ascend Laboratories recalls →

Other drugs & medical recalls in the United States

  1. 2026-06-17
  2. US
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    Fresh Roast Systems Inc recalls Fresh Roast Systems ColorTrack. Model Name: ColorTrack. Model Number: BENCH R-100

    A defect has been identified in the manufacture of the Fresh Roast Systems ColorTrack instrument model number BENCH R-100 which could under very rare specific misuse circumstances potentially allow human access to…

    FDA · DeviceFresh Roast Systems IncU.S.Official notice →
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    BEEKEEPER'S NATURALS USA INC. recalls BEEKEEPER'S NATURALS Saline Nasal Spray, Sinus Congestion Rinse, Made with Propolis + Xylitol, 1 FL OZ (30 mL) per bottle,…

    Microbial Contamination of Non-Sterile Products

    FDA · DrugBEEKEEPER'S NATURALS USA INC.Nationwide within the United States.Official notice →
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    SUN PHARMACEUTICAL INDUSTRIES INC recalls Budesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampules (5 Single-Dose Ampules per pouch, 6 pouches…

    Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles within the ampoule solution

    FDA · DrugSUN PHARMACEUTICAL INDUSTRIES INCNationwide within the United StatesOfficial notice →
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    Haleon US Holdings LLC recalls Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS, packaged in a) 120 SoftGels (UPC 3 00674 35041 9, b) 72 SoftGels (UPC 3 00439 00572 1),…

    Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.

    FDA · DrugHaleon US Holdings LLCNationwide within the United StatesOfficial notice →
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    Golden State Medical Supply Inc. recalls GSMS Incorporated, NIACIN EXTENDED-RELEASE TABLETS, USP, 1,000 MG, 90 tablets, Rx only, Manufactured by Kremers Urban…

    Failed Dissolution Specifications: During 12-month long-term stability testing, subject lot was out of specification (low) for stage 3 dissolution at the 24-hour timepoint.

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