Recall Atlas
Drugs & medicalClass II

AvKARE recalls Silodosin Capsules, 8mg, 90-count bottle, Rx only, Manufactured for: AvKare, Pulaski, TN 38478, Manufactured by: Amneal Pharmaceuticals of…

Subpotent Drug: Out of Specification (OOS) result for De hydro Impurity (0.654%) for 18 M Stability sample and low assay 94.9% (specification of NLT 95.0% NMT 105%)

Read the official notice →
Date
2025-02-26
Country
United States
Brand
AvKARE
Product
Silodosin Capsules, 8mg, 90-count bottle, Rx only, Manufactured for: AvKare, Pulaski, TN 38478, Manufactured by: Amneal Pharmaceuticals of…
Classification
Class II
Units
USA 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 Details may be shortened or out of date; the official notice is the authoritative source.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 AvKARE recalls

  1. 2025-07-09
  2. US
    Drugs & medicalClass III

    AvKARE recalls Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-905-90

    Failed Impurity/Degradation Specifications

    FDA · DrugAvKARENationwide in the USAOfficial notice →
  3. 2025-06-18
  4. US
    Drugs & medicalClass II

    AvKARE recalls Chlorthalidone Tablets, USP, 25 mg, 50 Tablets (5x10) Unit Dose cards per carton, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478,…

    Failed Dissolution Specifications

    FDA · DrugAvKARENationwide USAOfficial notice →
  5. US
    Drugs & medicalClass II

    AvKARE recalls Celecoxib Capsules, 200 mg, 50 Capsules (5x10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-169-15

    Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsules

    FDA · DrugAvKARENationwide in the USAOfficial notice →
  6. 2025-02-19
  7. US
    Drugs & medicalClass II

    AvKARE recalls Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-442-15

    Out of Specification for Dissolution

    FDA · DrugAvKARENationwide in the USAOfficial notice →
  8. 2025-01-08
  9. US
    Drugs & medicalClass III

    AvKARE recalls Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by:…

    LABELING: LABEL MIX-UP

    FDA · DrugAvKARENationwide within the United StatesOfficial notice →
  10. US
    Drugs & medicalClass II

    AvKARE recalls Nitrofurantoin Capsules, USP, 100 mg, 50 Capsules (5 x 10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN…

    Failed Dissolution Specifications

    FDA · DrugAvKARENationwide USAOfficial notice →
All 19 AvKARE recalls →

Other drugs & medical recalls in the United States

  1. 2025-02-26
  2. US
    Drugs & medicalClass I

    Alvogen, Inc recalls Fentanyl Transdermal System CII, 25mcg/h, packaged in a pouch, further packaged in 5-count carton, Rx only, Distributed by: Alvogen, Inc.,…

    Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.

    FDA · DrugAlvogen, IncUSA NationwideOfficial notice →
  3. US
    Drugs & medicalClass II

    Glenmark Pharmaceuticals Inc., USA recalls Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA,…

    CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

    FDA · DrugGlenmark Pharmaceuticals Inc., USANationwide within the U.SOfficial notice →
  4. US
    Drugs & medicalClass I

    Provepharm Inc. recalls Phenylephrine HCl Injection, USP 100 mg/10 mL (10 mg/mL) vials, Rx only, Pharmacy Bulk Package (supplied as a single unit), Dist. by:…

    Presence of Particulate Matter.

    FDA · DrugProvepharm Inc.Nationwide in the U.S.Official notice →
  5. US
    Drugs & medicalClass II

    The Harvard Drug Group LLC dba Major Pharmaceuticals and… recalls Lorazepam Tablets, USP, 0.5mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The…

    Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.

    FDA · DrugThe Harvard Drug Group LLC dba Major Pharmaceuticals and…Nationwide U.S. and Puerto ricoOfficial notice →
  6. US
    Drugs & medicalClass II

    Fagron Compounding Services recalls fentaNYL Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII, Single use 100mL IV Bag, Fagron Sterile Services, 8710 E 34th…

    Lack of Assurance of Sterility

    FDA · DrugFagron Compounding ServicesDistributed in PAOfficial notice →
  7. 2025-02-19
  8. US
    Drugs & medicalClass II

    Hologic, Inc recalls Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Sertera-14 Software Version: N/A Product…

    Devices presented a condition in which the inner needle separated from the hub and produced a longer throw of the inner needle or dislodgement.

    FDA · DeviceHologic, IncDomestic: Nationwide DistributionOfficial notice →
See all drugs & medical recalls →