Source

FDA Recalls

The U.S. Food and Drug Administration regulates drugs, medical devices, food, cosmetics, and tobacco products. Recall data here includes pharmaceutical adverse events and drug recalls.

68,659Total Recalls
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68,659 recalls
High RiskFDA
Sunquest Information Systems, Inc.
Sunquest Laboratory Sunquest Laboratory is intended for use by professionals working in a clinical laboratory. Sunquest Laboratory is ...
Medical Devices·126 affected·Mar 15, 2012
High RiskFDA
Zydus Pharmaceuticals Usa Inc
Metformin Hydrochloride Tablets, USP, 1000 mg, Rx only, 1000 count tablets per Bottle, Manufactured by: Cadila Healthcare LTD. Ahmedabad...
Oral Drugs·1,176 affected·Mar 14, 2012
High RiskFDA
Surgical Tissue Network, Inc.
UltraFill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: UltraFill DBM Size: 5cc Product Code: RT53005 Donated Huma...
Medical Devices·208 affected·Mar 14, 2012
High RiskFDA
Surgical Tissue Network, Inc.
UltraFill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: UltraFill DBM Size: 10cc Product Code: RT53010 Donated Hu...
Medical Devices·160 affected·Mar 14, 2012
High RiskFDA
Surgical Tissue Network, Inc.
Ultrafill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: UltraFill DBM Size: 1cc Product Code: RT53001 Donated Human Tis...
Medical Devices·25 affected·Mar 14, 2012
High RiskFDA
Advanced Sterilization Products
STERRAD 200 System Carriage, P/N 10208. Used as a tool to expedite loading and unloading processed items from a STERRAD 200 sterilizer.
Medical Devices·2,457 affected·Mar 13, 2012
High RiskFDA
Medtest Holdings, Inc.
Pointe Scientific Hitachi Total Bilirubin Rl Reagent Product Usage: Two part Chemistry Reagent Hitachi Total Bilirubin Rl Reagent is ...
Diagnostic Devices·270 affected·Mar 13, 2012
High RiskFDA
Depuy Mitek, Inc., A Johnson & Johnson Co.
DePuy Mitek VAPR Hook Electrode 3.5mm Hook Electrode with Integrated Handpiece Catalog Number: 227305 The DePuy Mitek VAPR Electro...
Medical Devices·376 affected·Mar 12, 2012
CriticalFDA
The Menz Club, Llc
Blue Male Enhancement Pill, bulk product, by The Menz Club, Ridgeland, MS
Oral Drugs·50,000 affected·Mar 10, 2012
High RiskFDA
Aurobindo Pharma Ltd
Northstar Zolpidem Tartrate Tablets USP 10 mg. Manufactured for Northstar RX, LLC Memphis, TN 38141. Manufactured by Aurobindo Pharma L...
Oral Drugs·23,616 affected·Mar 9, 2012
RecallFDA
Pack Pharmaceuticals
Ciprofloxacin Tablets, USP, 500 mg, Rx Only, 100 Tablets per Bottle, Manufactured in India by: Unique Pharmaceutical Laboratories (A Divi...
Oral Drugs·4,848 affected·Mar 9, 2012
High RiskFDA
Princeton Biomeditech Corp
Poly stat Flu A & B Test Manufactured for Polymedco 510 Furnace Dock Road Cortlandt Manor, NY 10567 Tel 800-431-2123 914-7...
Respiratory Devices·103 affected·Mar 9, 2012
High RiskFDA
Princeton Biomeditech Corp
Status Flu A + B Test Manufactured by Princeton Bio Meditech Corporation Monmouth Junction, NJ 08852 USA. The BioSign Flu A + B te...
Respiratory Devices·90 affected·Mar 9, 2012
High RiskFDA
Shionogi Inc.
Nisoldipine Extended Release Tablets, 17mg, 100 count bottle, Rx only, Manufactured for: Prasco Laboratories Mason OH 45040, Manufacture...
Oral Drugs·7,230 affected·Mar 8, 2012
RecallFDA
Helix Medical Llc
BLOM-SINGER indwelling TEP Occluder, catalog IN2004-TO The Blom-Singer Indwelling (TEP(tracheoesophageal Puncture) Occluder is a non-v...
Medical Implants·2 affected·Mar 8, 2012
High RiskFDA
Depuy Orthopaedics, Inc.
Pinnacle Hip Solutions ALTRX Polyethylene Acetabular Liner, Ref 1221-36-452 Product Usage: An acetabular liner is used in combination...
Medical Implants·20 affected·Mar 7, 2012
High RiskFDA
Aesculap Implant Systems Llc
S4 Cervical (S4C) Revision Instruments (FW099R and FW101R). The S4C Revision Instruments assist in the removal of an occipital cervical ...
Medical Devices·15 affected·Mar 7, 2012
RecallFDA
Becton Dickinson & Company
BD Vacutainer PST Gel and Lithium Heparin (LH); 83 Units; Plus Blood Collection Tubes; Sterile; IVD; REF 367962; 4.5 mL, 13 X 100 mm; BD,...
Medical Devices·225 affected·Mar 5, 2012
High RiskFDA
Abbott Point Of Care Inc.
I-STAT PT/INR cartridge Abbott Point of Care Inc. Abbott Park, IL 60064 USA This cartridge is useful for monitoring patients receivi...
Medical Devices·2,950,296 affected·Mar 1, 2012
High RiskFDA
Lloyd Inc
Thyro-Tab.075 mg., packaged in bulk drums for repackaging. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, Iowa 51601.
Drugs·1,913,236 affected·Feb 24, 2012
High RiskFDA
Lloyd Inc
Levothroid (levothyroxine sodium tablets, USP), 75 mcg., 100-count bottles, Rx only, NDC 0456-1322-01, Manufactured for Forest Pharmace...
Oral Drugs·19,039 affected·Feb 24, 2012
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens syngo.plaza. Radiological image processing system
Medical Devices·2 affected·Feb 24, 2012
RecallFDA
Roche Molecular Systems, Inc.
Cobas KRAS Mutation Test for In Vitro Diagnostic Use Product Usage: Usage: The Cobas KRAS Mutation Test, for use with the Cobas 4800...
Diagnostic Devices·264 affected·Feb 24, 2012
CriticalFDA
Www.vitaminbestbuy.com
Japan Weight Loss Blue Capsules, 9 g (300 mg), 30 count box, Green algae lipotropic (fat dissolving) agent, OTC, Distributed by Vitaminbe...
Oral Drugs·52 affected·Feb 23, 2012
CriticalFDA
Www.vitaminbestbuy.com
Man King Capsules, 2800 mg, boxes of 5 packets, OTC, Developed by: American Wanbao Pharmaceutical International Group and Hainan Wanbao ...
Oral Drugs·69 affected·Feb 23, 2012
CriticalFDA
Www.vitaminbestbuy.com
Hard Ten Days Capsule, 4500 mg, boxes of 6 packets, OTC, Developed by: American Federal International Living Creature Group and Tibet Go...
Oral Drugs·550 affected·Feb 23, 2012
High RiskFDA
American Optisurgical Inc
TX1 Tissue Removal System Console. Model: TX1 TX1 Tissue Removal System is an ultrasonic aspirator that emulsifies and removes soft tiss...
Surgical Devices·5 affected·Feb 22, 2012
High RiskFDA
Biomet Spine, Llc
Timberline Cranial Caudal and Posterior Blades, 40 - 180mm Model # 8734-2XXX, 8734-5XXX is a reusable device provided within an aluminum ...
Medical Devices·213 affected·Feb 22, 2012
High RiskFDA
Aesculap Implant Systems
Columbus Tibia Plateau (component of the Columbus REVISION Knee System) Product Usage - The Columbus Revision Knee System is indicated...
Medical Devices·8 affected·Feb 21, 2012
High RiskFDA
Toshiba American Medical Systems Inc
Toshiba Ultra-Short Magnetic Resonance Imaging System, EXCELART Vantage. MRT-1503/P5-Vantage MRI System. MR imaging.
Medical Devices·3 affected·Feb 21, 2012
High RiskFDA
Physicians Total Care, Inc.
PHYSICIANS TOTAL CARE, TETRACYCLINE, 250 mg, 30 CAPSULES, bottle MFG. BY: TEVA PHARMACEUTICALS USA, SELLERSVILLE PA 18960 NDC 54868-0024-08
Oral Drugs·1,200 affected·Feb 20, 2012
High RiskFDA
Physicians Total Care, Inc.
PHYSICIANS TOTAL CARE, TETRACYCLINE, 500 mg, 30 CAPSULES, bottle MFG. BY: TEVA PHARMACEUTICALS USA, SELLERSVILLE PA 18960 NDC 54868-0025-09
Oral Drugs·3,660 affected·Feb 20, 2012
CriticalFDA
Maquet Cardiovascular Us Sales, Llc
FLOW-I Anesthesia System The system is intended for use in administrating anesthesia while controlling the entire ventilation for pati...
Respiratory Devices·284 affected·Feb 20, 2012
High RiskFDA
Vital Signs Devices, A Ge Healthcare Company
enFlow IV Fluid Warmer (510k name: EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, M...
Medical Devices·11,803 affected·Feb 20, 2012
High RiskFDA
Sunshine Peanut Company
Sunny Boy Peanut Butter. Product is labeled in part: 6/5 lb tubs- "SunnyBoy Creamy PEANUT BUTTER***Net Wt. 5lb. (2.27KG)***INGREDIENT...
Dairy·72 affected·Feb 17, 2012
High RiskFDA
Sunshine Peanut Company
Product is 1 oz Peanut Butter. 1 oz pouch labeled in part: "PEANUT BUTTER***Ingredients: Roaster Peanuts, Sugar, Stabilizer (Rapeseed Co...
Dairy·0 affected·Feb 17, 2012
High RiskFDA
Sunshine Peanut Company
Sunny Boy Low Sodium/ Low Salt Peanut Butter. Product is labeled in part: 35 lb pail labeled in part: ""SunnyBoy LowSodium/LowSalt***...
Dairy·846 affected·Feb 17, 2012
High RiskFDA
Sunshine Peanut Company
Product is 2 oz Peanut Butter. 2 oz pouch labeled in part: "PEANUT BUTTER 2 oz. Pouch***Ingredients: Roaster Peanuts, Sugar, Hydrogenate...
Dairy·406 affected·Feb 17, 2012
High RiskFDA
Sunshine Peanut Company
Sunny Boy NoSalt Peanut Butter. No label was provided by the firm for this product. Product would have been labeled in part: "***Sunn...
Dairy·12 affected·Feb 17, 2012
High RiskFDA
Sunshine Peanut Company
Product is 50 lb Bag Peanut Butter. Product Case is labeled in part: "***50 Lbs Bag***PEANUT BUTTER***PRODUCT OF USA*** 50 Lb B...
Dairy·48 affected·Feb 17, 2012
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Carescape Patient Data Module with v2.0 software used with Solar 8000M/l, Transport Pro or Carescape B650/B850 host monitor...
Medical Devices·10,250 affected·Feb 17, 2012
RecallFDA
Medtest Holdings, Inc.
Pointe Scientific Hitachi AST Reagent R1 : PE plastic bottle w/PP plastic cap. R2: PE plastic bottle w /PP plastic cap. Product Us...
Diagnostic Devices·119 affected·Feb 15, 2012
High RiskFDA
Daaks International
Fenugreek, 3 dozen per case.
Food·388 affected·Feb 13, 2012
High RiskFDA
Ossur Americas, Inc.
The Symbionic Leg is an integrated prosthetic leg for transfemoral and knee disarticulation amputees. The prosthesis is composed of t...
Medical Implants·17 affected·Feb 12, 2012
High RiskFDA
Covidien Llc Dba Uni-patch
Empi STIMC RE Self Adhesive electrodes. For use on TENS, NMES, FES. a DJO brand A cutaneous electrode is an electrode that is appli...
Medical Devices·28,138 affected·Feb 9, 2012
High RiskFDA
Integra Lifesciences Corp.
Integra¿ Advansys Medial Lisfranc Plate (MLP), Integra, 311 Enterprise Drive, Plainsboro, NJ 08536 The Advansys plates are intended f...
Medical Devices·2,437 affected·Feb 9, 2012
High RiskFDA
Covidien Llc Dba Uni-patch
Performa reusable and self-adhering TENS/NMES/FES stimulating electrodes, A cutaneous electrode is an electrode that is applied direct...
Medical Devices·3,290 affected·Feb 9, 2012
High RiskFDA
Covidien Llc Dba Uni-patch
Reusable, non-sterile, self-adhering electrodes for use with TENS/NMES, . Made in the U.S.A. Cutaneous electrode is an electrode that i...
Medical Devices·2,014 affected·Feb 9, 2012