Drug and pharmaceutical recalls
17625 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2018-02-07FDA-DrugA&H Focal Inc.Class IDADIYONGSHI XIANGGANGTIANLONGSHENGWU tablets, 6-count bottle, labeling is in foreign language
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
- 2018-02-07FDA-DrugA&H Focal Inc.Class IPower V8 Viagra tablets, 200mg, 10-Grain bottle, labeling is in foreign language
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
- 2018-02-07FDA-DrugA&H Focal Inc.Class IYANSHIJIAONANG capsules, 2000mg, 8-count bottle, labeling is in foreign language
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
- 2018-02-07FDA-DrugA&H Focal Inc.Class IHU HU SHENG WEI capsules, 3000 mg, 2-count bottle, labeling is in foreign language
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
- 2018-02-07FDA-DrugA&H Focal Inc.Class IIMAX MAN capsules, 3000 mg, 6-count bottle, labeling is in foreign language
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
- 2018-02-07FDA-DrugA&H Focal Inc.Class IISTREE OVERLORD capsules, 3800 mg, 4-count bottle, labeling is in foreign language
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
- 2018-02-07FDA-DrugA&H Focal Inc.Class IZhonghua Niubian tablets, 2000mg, 6-count bottle, labeling is in foreign language
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
- 2018-02-07FDA-DrugA&H Focal Inc.Class IZHANSHENG WEIGE CHAOYUE XILISHI tablets, 2000 mg, 6-count bottle, labeling is in foreign language
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
- 2018-02-07FDA-DrugA&H Focal Inc.Class IIYe Lang Shen capsules, 5000 mg, 8-count bottle, labeling is in foreign language
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
- 2018-02-07FDA-DrugA&H Focal Inc.Class IClalis capsules, 50mg, 6-count bottle, labeling is in foreign language
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
- 2018-02-07FDA-DrugA&H Focal Inc.Class IGOLD VIGRA capsules, 50mg, 6-count bottle, labeling is in foreign language
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
- 2018-02-07FDA-DrugA&H Focal Inc.Class ILANG YI HAO CHAONONGSUOPIAN tablets, 500 mg, 8-count bottle, labeling is in foreign language
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
- 2018-02-07FDA-DrugA&H Focal Inc.Class IIHARD TEN DAYS capsules, 4500mg, 6-count bottle, labeling is in foreign language
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
- 2018-02-07FDA-DrugA&H Focal Inc.Class IGERMANY NIUBIAN tablets, 3000mg, 10-count bottle, labeling is in foreign language
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
- 2018-02-07FDA-DrugA&H Focal Inc.Class IGERMANY BLACK GOLD tablets, 2800 mg, 8-count bottle, labeling is in foreign language
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
- 2018-02-07FDA-DrugA&H Focal Inc.Class IMiraculous Evil Root capsules, 1200 mg, 6-count bottle, labeling is in foreign language
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
- 2018-02-07FDA-DrugA&H Focal Inc.Class IIIIndian God Lotion Spray Bottle, labeling is in foreign language
Marked Without An Approved NDA/ANDA: FDA analysis found this product to contain diethyl phthalate, an inactive ingredient in several modified release solid oral dosage forms, making this product unapproved drug for which safety and efficacy have not been establish and therefore, subject to recall.
- 2018-02-07FDA-DrugA&H Focal Inc.Class IIBlack Ant capsules, 4600mg, 4-count blister pack, labeling is in foreign language
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
- 2018-02-07FDA-DrugInternational Laboratories, LLCClass IClopidogrel Tablets, USP 75 mg, 30-count bottles, Rx only, Packaged for: International Laboratories, LLC St. Petersburg, FL 33710, NDC 54458-888-16
LABELING: LABEL MIX-UP. Simvastatin tablets, USP 10 mg were found in bottles labeled as Clopidogrel tablets, USP 75 mg.
- 2018-02-07FDA-DrugFresenius Kabi USA, LLCClass IIIVecuronium bromide for Injection, 10 mg vials, Rx only, Mfd. for: Fresenius Kabi, Lake Zurich, IL 60047, Made in India, NDC 63323-781-10
Failed impurities/ degradation specifications: Out-of-specification (OOS) result for USP related compound F at the 12 month stability test station.
- 2018-02-07FDA-DrugDr. Reddy's Laboratories, Inc.Class IIIAtorvastatin Calcium Tablets 40 mg, 90 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-123-05
Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
- 2018-02-07FDA-DrugDr. Reddy's Laboratories, Inc.Class IIIAtorvastatin Calcium Tablets 20 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-122-05
Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
- 2018-02-07FDA-DrugDr. Reddy's Laboratories, Inc.Class IIIAtorvastatin Calcium Tablets 10 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-121-05
Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
- 2018-02-07FDA-DrugAbbVie Inc.Class IIIUltane (sevoflurane), 250 mL, Inhalation Anesthetic, Rx only, Manufactured by: AbbVie Inc., North Chicago, IL 60064, USA. NDC 0074-4456-51
Defective container: presence of a hole in the liners of the caps covering the product bottle, introducing possibility of leakage.
- 2018-02-07FDA-DrugPD-Rx Pharmaceuticals, Inc.Class IIPD-Rx Pharmaceuticals Incorporated Ibuprofen 200 mg tablets a) 24 tablets NDC 55289-673-24; b) 30 tablets NDC 55289-673-30; c) 50 tablets NDC 55289-673-50; d) 60 tablets NDC 55289-673-60
CGMP deviations.
- 2018-02-07FDA-DrugGlenmark Pharmaceuticals Inc., USAClass IIGlenmark Mometasone Furoate Cream, USP, 0.1%, 45 g Rx Only Manufactured by: Glenmark Pharmaceuticals Ltd. Village Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 NDC 68462019255 UPC 3684620192559
CGMP Deviations: Market complaints related to "gritty texture".
- 2018-02-07FDA-DrugMedline Industries IncClass IIMedline Incision & Drainage Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
- 2018-02-07FDA-DrugMedline Industries IncClass IIMedline Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
- 2018-02-07FDA-DrugMedline Industries IncClass IIMedline Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
- 2018-02-07FDA-DrugMedline Industries IncClass IIMedline Abdominal Surgery II Pack-LF, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
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