FDA Drug Recalls

18043 recall notices on file. Class I recalls involve a reasonable probability of serious adverse health consequences or death.

ProductFirmClassificationStatusReport date
All sterile drug preparations remaining within expiry prepared from Morphine Sulfate PF Base Solution dispensed between October 16, 2017 and November 17, 2017, Compounded by Intrathecal Compounding Specialists, Scott, LA 70583. Intrathecal Compounding Specialist, LLC Class II Terminated 20180214
All sterile drug preparations remaining within expiry prepared from Hydromorphone Base Solution dispensed between October 16, 2017 and November 17, 2017, Compounded by Intrathecal Compounding Specialists, Scott, LA 70583. Intrathecal Compounding Specialist, LLC Class II Terminated 20180214
All sterile drug preparations remaining within expiry prepared from Fentanyl Citrate Base Solution dispensed between October 16, 2017 and November 17, 2017 Compounded by Intrathecal Compounding Specialists, Scott, LA 70583. Intrathecal Compounding Specialist, LLC Class II Terminated 20180214
Ciclopirox Olamine Cream USP, 0.77%, packaged in a) 15 g tubes (NDC 0713-0638-15); b) 30 g tubes (NDC 0713-0638-31); and c) 90 g tubes (NDC 0713-0638-18), Rx Only, Manufactured by: G&W Laboratories, Inc., South Plainfield, NJ 07080. G & W Laboratories, Inc. Class III Terminated 20180214
Nexterone (amiodarone HCl) Premixed Injection, 150mg/100mL, 100-mL bag, Rx Only, Sterile, Baxter Healthcare Corporation, Deerfield, IL. NDC 43066-150-10 Baxter Healthcare Corporation Class I Terminated 20180207
Tiger King tablets, labeling is in foreign language A&H Focal Inc. Class II Terminated 20180207
MACA gold tablets, 6800 mg, 10-count bottle, labeling is in foreign language A&H Focal Inc. Class I Terminated 20180207
LIEN CHAN FOR SEVEN DAYS capsules, labeling is in foreign language A&H Focal Inc. Class I Terminated 20180207
DADIYONGSHI XIANGGANGTIANLONGSHENGWU tablets, 6-count bottle, labeling is in foreign language A&H Focal Inc. Class I Terminated 20180207
Power V8 Viagra tablets, 200mg, 10-Grain bottle, labeling is in foreign language A&H Focal Inc. Class I Terminated 20180207
YANSHIJIAONANG capsules, 2000mg, 8-count bottle, labeling is in foreign language A&H Focal Inc. Class I Terminated 20180207
HU HU SHENG WEI capsules, 3000 mg, 2-count bottle, labeling is in foreign language A&H Focal Inc. Class I Terminated 20180207
MAX MAN capsules, 3000 mg, 6-count bottle, labeling is in foreign language A&H Focal Inc. Class II Terminated 20180207
STREE OVERLORD capsules, 3800 mg, 4-count bottle, labeling is in foreign language A&H Focal Inc. Class II Terminated 20180207
Zhonghua Niubian tablets, 2000mg, 6-count bottle, labeling is in foreign language A&H Focal Inc. Class I Terminated 20180207
ZHANSHENG WEIGE CHAOYUE XILISHI tablets, 2000 mg, 6-count bottle, labeling is in foreign language A&H Focal Inc. Class I Terminated 20180207
Ye Lang Shen capsules, 5000 mg, 8-count bottle, labeling is in foreign language A&H Focal Inc. Class II Terminated 20180207
Clalis capsules, 50mg, 6-count bottle, labeling is in foreign language A&H Focal Inc. Class I Terminated 20180207
GOLD VIGRA capsules, 50mg, 6-count bottle, labeling is in foreign language A&H Focal Inc. Class I Terminated 20180207
LANG YI HAO CHAONONGSUOPIAN tablets, 500 mg, 8-count bottle, labeling is in foreign language A&H Focal Inc. Class I Terminated 20180207
HARD TEN DAYS capsules, 4500mg, 6-count bottle, labeling is in foreign language A&H Focal Inc. Class II Terminated 20180207
GERMANY NIUBIAN tablets, 3000mg, 10-count bottle, labeling is in foreign language A&H Focal Inc. Class I Terminated 20180207
GERMANY BLACK GOLD tablets, 2800 mg, 8-count bottle, labeling is in foreign language A&H Focal Inc. Class I Terminated 20180207
Miraculous Evil Root capsules, 1200 mg, 6-count bottle, labeling is in foreign language A&H Focal Inc. Class I Terminated 20180207
Indian God Lotion Spray Bottle, labeling is in foreign language A&H Focal Inc. Class III Terminated 20180207
Black Ant capsules, 4600mg, 4-count blister pack, labeling is in foreign language A&H Focal Inc. Class II Terminated 20180207
Clopidogrel Tablets, USP 75 mg, 30-count bottles, Rx only, Packaged for: International Laboratories, LLC St. Petersburg, FL 33710, NDC 54458-888-16 International Laboratories, LLC Class I Terminated 20180207
Vecuronium bromide for Injection, 10 mg vials, Rx only, Mfd. for: Fresenius Kabi, Lake Zurich, IL 60047, Made in India, NDC 63323-781-10 Fresenius Kabi USA, LLC Class III Terminated 20180207
Atorvastatin Calcium Tablets 40 mg, 90 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-123-05 Dr. Reddy's Laboratories, Inc. Class III Terminated 20180207
Atorvastatin 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 Dr. Reddy's Laboratories, Inc. Class III Terminated 20180207
Atorvastatin 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 Dr. Reddy's Laboratories, Inc. Class III Terminated 20180207
Ultane (sevoflurane), 250 mL, Inhalation Anesthetic, Rx only, Manufactured by: AbbVie Inc., North Chicago, IL 60064, USA. NDC 0074-4456-51 AbbVie Inc. Class III Terminated 20180207
PD-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 PD-Rx Pharmaceuticals, Inc. Class II Terminated 20180207
Glenmark 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 Glenmark Pharmaceuticals Inc., USA Class II Terminated 20180207
Medline Incision & Drainage Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093 Medline Industries Inc Class II Terminated 20180207
Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060 Medline Industries Inc Class II Terminated 20180207
Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060 Medline Industries Inc Class II Terminated 20180207
Medline Abdominal Surgery II Pack-LF, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093 Medline Industries Inc Class II Terminated 20180207
Medline Incision Drainage Tray, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060 Medline Industries Inc Class II Terminated 20180207
Medline Skin Stapler RMVR, Tray Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060 Medline Industries Inc Class II Terminated 20180207
Professional Hospital Supply Suture Removal Kit, Sterile, Single Use Only. Packaged in Mexico for Professional Hospital Supply, Inc., 41980 Winchester Rd., Temecula, CA 92590 Medline Industries Inc Class II Terminated 20180207
Medline Suture Removal Pack Latex Safe, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093 Medline Industries Inc Class II Terminated 20180207
Professional Hospital Supply Suture Removal Kit, Sterile, Single Use Only. Packaged in Mexico for Professional Hospital Supply, Inc., 41980 Winchester Rd., Temecula, CA 92590 Medline Industries Inc Class II Terminated 20180207
Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060 Medline Industries Inc Class II Terminated 20180207
Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060 Medline Industries Inc Class II Terminated 20180207
Medline Incision and Drainage Tray, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060 Medline Industries Inc Class II Terminated 20180207
Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060 Medline Industries Inc Class II Terminated 20180207
Medline Anesthesia Kit, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Northfield, IL 60093 Medline Industries Inc Class II Terminated 20180207
Medline Incision Drainage Kit, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060 Medline Industries Inc Class II Terminated 20180207
Medline Hip Replacement, Kit, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Northfield, IL 60093 Medline Industries Inc Class II Terminated 20180207