Recall Atlas
Drugs & medicalClass II

Ajanta Pharma USA Inc recalls Fenofibrate Capsules, USP 200 mg, Rx only, 100 Capsules, Manufactured by: Ajanta Pharma Limited, India, Marketed by: Ajanta Pharma USA…

CGMP Deviations

Read the official notice →
Date
2026-07-01
Country
United States
Brand
Ajanta Pharma
Product
Fenofibrate Capsules, USP 200 mg, Rx only, 100 Capsules, Manufactured by: Ajanta Pharma Limited, India, Marketed by: Ajanta Pharma USA…
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 Details may be shortened or out of date; the official notice is the authoritative source.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 Ajanta Pharma recalls

  1. 2026-10-07
  2. US
    Drugs & medicalClass II

    Ajanta Pharma USA Inc recalls Ranolazine Extended-Release Tablets, 1000 mg, 60-count bottle, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807. NDC:…

    Failed Dissolution Specifications: below specification

    FDA · DrugAjanta Pharma USA IncNationwide in the US.Official notice →
  3. 2026-09-16
  4. US
    Drugs & medicalClass III

    Ajanta Pharma USA Inc recalls Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made…

    Failed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) during testing at the 18 months long term stability. Result: 1.1 percent. Spec: 1.0 percent.

    FDA · DrugAjanta Pharma USA IncNationwide within the U.SOfficial notice →
  5. 2026-06-24
  6. US
    Drugs & medicalClass II

    Ajanta Pharma USA Inc recalls Aripiprazole Tablets USP, Rx only, 30 mg, 30 tablets, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC…

    Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.

    FDA · DrugAjanta Pharma USA IncU.S. NationwideOfficial notice →
  7. 2026-05-13
  8. US
    Drugs & medicalClass II

    Ajanta Pharma Ltd. recalls Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-098-09, b) 30 capsules, NDC 27241-098-03, c) 1000 Capsules,…

    CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.

    FDA · DrugAjanta Pharma Ltd.Nationwide within U.SOfficial notice →
All 5 Ajanta Pharma recalls →

Other drugs & medical recalls in the United States

  1. 2026-07-01
  2. US
    Drugs & medicalClass II

    Direct Rx recalls DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60), 60 Caps; CYMBALTA, Packaged and Distributed by Direct Rx.

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

    FDA · DrugDirect RxU.S. NationwideOfficial notice →
  3. US
    Drugs & medicalClass II

    Amgen, Inc. recalls Corlanor (ivabradine) tablets, 7.5mg, 60-count bottles, Rx Only, Amgen Inc., Thousand Oaks, CA 92130 Made In Italy. NDC 55513-810-60

    Presence of Foreign Substance.

    FDA · DrugAmgen, Inc.Nationwide within the United StatesOfficial notice →
  4. US
    Drugs & medicalClass II

    Amgen, Inc. recalls Sensipar (cinacalcet) Tablets, 60mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks ,CA…

    CGMP Deviations

    FDA · DrugAmgen, Inc.Nationwide within the United StatesOfficial notice →
  5. US
    Drugs & medicalClass II

    The Harvard Drug Group LLC recalls Carton Label: MAJOR, Methylergonovine Maleate Tablets, USP, 0.2 mg, 20 TABLETS (2 x 10), Rx only, Packaged and Distributed by: MAJOR…

    Subpotent Drug

    FDA · DrugThe Harvard Drug Group LLCU.S. Nationwide.Official notice →
  6. 2026-06-24
  7. US
    Drugs & medicalClass II

    Thoratec LLC recalls Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US Software Version: N/A Product…

    Due to 11 volt Backup Battery failures.

    FDA · DeviceThoratec LLCWorldwide - US Nationwide distribution including in the states of AL, AR, AZ,…Official notice →
  8. US
    Drugs & medicalClass II

    Merit Medical Systems, Inc. recalls Splashwire Hydrophilic Guide Wire: REF: MSWSTDA35150 UDI-DI codes: 00884450529645 00884450529669 00884450529690 REF: MSWSTDA35180…

    Due to unsealed portions of pouches.

    FDA · DeviceMerit Medical Systems, Inc.Worldwide - U.S. Nationwide distribution in the states and territory AL, AZ,…Official notice →
See all drugs & medical recalls →