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
Philips Medical Systems, Inc.
Philips HeartStart MRx Monitor/Defibrillator used Model numbers: M3535A, M3536A, M3536J, M3536M, M3536MC
Cardiac Devices·58,466 affected·Feb 4, 2014
High RiskFDA
Focus Diagnostics Inc
Simplexa Flu AlB & RSV Direct Assay Kits, intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV v...
Diagnostic Devices·2,175 affected·Feb 4, 2014
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Optiflux F18Nre Flux Dialyzers; Product Number: 0500308E. Single Use acute or chronic hemanalysis treatment.
Medical Devices·34,752 affected·Feb 4, 2014
CriticalFDA
Humei Trading Inc.
Humei Foods DRIED LILY, Net Wt. 340 g 12 oz +- 5 g -- PRODUCT OF CHINA --- Firms on label: Shanghai Dingmei International Trade Co., LTD,...
Food·30 affected·Feb 3, 2014
CriticalFDA
K-fat Inc.
KFI SWEETENED GINGER CANDY (Mut Gung), NET WEIGHT: 8.8 oz (250 g) - PRODUCT OF VIETNAM - UPC 8 935001 201304 -- Distributed by: K-FAT INC...
Snacks & Candy·75 affected·Feb 3, 2014
High RiskFDA
Innovative Sterlization Technologies Llc
OneTray Sealed Sterilization Containers Product Usage: A rigid sterilization container used to steam sterilize medical devices
Medical Devices·2,104 affected·Feb 3, 2014
High RiskFDA
Carl Zeiss Meditec Ag
Treatment packs used on the VisuMax Laser Keratome. Size M Manufactured by Carl Zeiss Meditec AG, Jena, Germany. The VisuMax Lase...
Medical Devices·1 affected·Feb 3, 2014
High RiskFDA
Altasource Llc Dba Meta Labs Llc
Hot Ice, 1 fl. oz., Meta Labs LLC, UPC 80705-2 Product Usage: A topical gel that increases men and womens secual excitement and plea...
Medical Devices·155 affected·Feb 3, 2014
High RiskFDA
Stryker Howmedica Osteonics Corp.
Citation TMZF HA 132 degrees Neck Angle, V40 Hip Stem - Right Size #3: catalog # 6265-5113 , Left Size #4: catalog #6265-5104 , and Rig...
Medical Implants·48 affected·Feb 3, 2014
High RiskFDA
Dayton Nut Specialties Inc
Creation Special Snack Mix; 25 lb. cardboard carton
Snacks & Candy·42 affected·Jan 31, 2014
High RiskFDA
Dayton Nut Specialties Inc
Bar Star Snack Mix; 25 lb. cardboard carton
Snacks & Candy·59 affected·Jan 31, 2014
High RiskFDA
Charlemagnes Tree Farm Ltd
HUDSON VALLEY HOMESTEAD BUSHWHACKER'S SAVORY SAUCE, Mild, Net Wt. 14 oz., UPC: 7 51122 00091 0, Hudson Valley Homstead 102 Sheldon Lane C...
Food·2,100 affected·Jan 31, 2014
RecallFDA
New Horizon Cuisine
New Horizon Cuisine Chicken Demi-Glace Xpress, packaged in 16-oz. plastic cups (6/case) and New Horizon Cuisine Chicken Demi-Glace packag...
Meat & Poultry·59 affected·Jan 31, 2014
High RiskFDA
Creation Gardens
Bar Star Snack Mix, 1 lb plastic bag and 25 lb plastic bags in a cardboard box. Box labeled DAYTON'S ESTABLISHED 1923 DAYTON NUT SPECIALT...
Snacks & Candy·271 affected·Jan 31, 2014
RecallFDA
Hill Dermaceuticals, Inc.
SETON PHARMACEUTICALS Fluocinolone acetonide 0.01% Topical Oil (Scalp Oil), 4 fl.oz., Rx only Manufactured by: Hill Dermaceuticals, Inc....
Topical Drugs·4,142 affected·Jan 31, 2014
RecallFDA
Hill Dermaceuticals, Inc.
Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Body Oil) 4 fl. oz., Rx only Manufactured and Distributed by: Hill Dermaceuti...
Topical Drugs·8,734 affected·Jan 31, 2014
RecallFDA
Hill Dermaceuticals, Inc.
SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Oil EAR DROPS, 20 ml, Rx only Manufactured by: Hill Dermaceuticals, Inc. For: Seton ...
Drugs·13,591 affected·Jan 31, 2014
High RiskFDA
American Health Packaging
HydrOXYzine HCl Tablets, USP 25 mg, 100 Tablet Blister, Rx only Mfd by: KVK-TECH, INC. Newtown, PA 18940, NDC 68084-254-01
Oral Drugs·14,665 affected·Jan 31, 2014
RecallFDA
Hill Dermaceuticals, Inc.
ROYAL PHARMACEUTICALS DermOtic Oil fluocinolone acetonide 0.01% (Ear Drops), 20 ml, Rx only Manufactured by: Hill Dermaceuticalsfor: Ro...
Drugs·13,379 affected·Jan 31, 2014
High RiskFDA
American Health Packaging
HydrOXYzine HCl Tablets, USP 50 mg, 100 Tablet Blister, Rx only Mfd by: KVK-TECH, INC. Newtown, PA 18940, NDC 68084-255-01
Oral Drugs·8,570 affected·Jan 31, 2014
RecallFDA
Hill Dermaceuticals, Inc.
Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Scalp Oil), 4 fl. oz., Rx only. Manufactured and Distributed by: Hill Dermace...
Topical Drugs·14,226 affected·Jan 31, 2014
RecallFDA
Hill Dermaceuticals, Inc.
DermOtic Oil (fluocinolone acetonide) 0.01% Ear Drops, 20 mL bottle, Rx only Manufactured and Distributed by: Hill Dermaceuticals, Inc. ...
Drugs·4,080 affected·Jan 31, 2014
RecallFDA
Hill Dermaceuticals, Inc.
ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Body Oil) 4 fl. oz., Rx only Manufactured by: Hill Derm...
Topical Drugs·8,734 affected·Jan 31, 2014
RecallFDA
Hill Dermaceuticals, Inc.
SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Topical Oil (Body Oil), 4 fl.oz., Rx only Manufactured by: Hill Dermaceuticals, Inc. ...
Topical Drugs·7,676 affected·Jan 31, 2014
RecallFDA
Hill Dermaceuticals, Inc.
ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% (Scalp Oil), 4 fl.oz., Rx only Manufactured by: Hill Dermaceuticals ...
Drugs·7,292 affected·Jan 31, 2014
High RiskFDA
Hospira Inc.
GemStar infusion pump, List numbers 13000 and 13100, GemStar Infusion Pump (pain management) List number 13150. Used for intrave...
Medical Devices·36,881 affected·Jan 31, 2014
High RiskFDA
Bock,otto,orthopedic Ind,inc
Otto Bock Aerial and Aerial Active Wheelchair Cushions. Material numbers: SK757 476C00=SK701, 476C00=SK702, 476C00=SK703, 476C00=SK704,...
Medical Devices·464 affected·Jan 31, 2014
CriticalFDA
Greatbatch Medical
Greatbatch Medical, Offset Cup Impactor. Part Numbers: P9485, T10243, T10281, T10287, T10484, T10491, T10507, T10600, T10604, T10753, T...
Medical Implants·4,870 affected·Jan 31, 2014
CriticalFDA
Unified Grocers Inc.
Ginger Snap Cookies, 12 oz., Item Code: 48918, UPC 0-41380-23359
Bakery & Grains·482 affected·Jan 30, 2014
High RiskFDA
Youngyou International Inc
Mega Slim Herbal Appetite Management, 30 Capsules Bottle. Product labeling reads in part:"MEGASLIM Herbal Appetite Management***30 Cap...
Beverages·27 affected·Jan 30, 2014
High RiskFDA
Mid Pac Foods, Inc.
Mid Pac Foods brand sauce for Char Sui; Net 7 FL. oz (207 ml); Made in Hawaii, Keep in cool place UPC: 7336620250 Manufactured by M...
Food·400 affected·Jan 30, 2014
High RiskFDA
Kci Usa, Inc.
PRE1001US: Prevena Peel and Place System Kit (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage t...
Surgical Devices·20,850 affected·Jan 30, 2014
High RiskFDA
Kci Usa, Inc.
PRE1055: Prevena Dressing, 5 Pack Product Usage: The Prevena Incision Management System is intended to manage the environment of surg...
Surgical Devices·20,850 affected·Jan 30, 2014
High RiskFDA
Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic Select CAP Arterial Cannulae. Non-Vented, Carmeda Coated, model CB78722 (22 Fr.). Sterilized using Ethylene Oxide. Non-pyrog...
Medical Devices·19,483 affected·Jan 30, 2014
High RiskFDA
Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic Select 3D Arterial Cannulae. Vented, models 78618 (18 Fr.) and 78620 (20 Fr.). Non-Vented Cannulae, models 78718 (18 Fr.) an...
Medical Devices·19,483 affected·Jan 30, 2014
High RiskFDA
Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic Select 3D Arterial Cannulae. Vented, model 78624 (24 Fr.). Non-Vented Cannulae, model 78724 (24 Fr.). Sterilized using Ethy...
Medical Devices·19,483 affected·Jan 30, 2014
High RiskFDA
Synthes, Inc.
Synthes CMF Battery Powered Driver, Part no. 305.840. Used to place screws in the cranialfacial bones, and to drill and/or tap holes to ...
Medical Devices·20,081 affected·Jan 30, 2014
High RiskFDA
Kci Usa, Inc.
PRE2055US: Prevena Customizable Dressing 5-Pack (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage...
Surgical Devices·20,850 affected·Jan 30, 2014
High RiskFDA
Kci Usa, Inc.
PRE2001: Prevena Incision Management Customizable System Box Product Usage: The Prevena Incision Management System is intended to man...
Surgical Devices·20,850 affected·Jan 30, 2014
High RiskFDA
Kci Usa, Inc.
PRE2055: Prevena Customizable Dressing 5-Pack Product Usage: The Prevena Incision Management System is intended to manage the environ...
Surgical Devices·20,850 affected·Jan 30, 2014
High RiskFDA
Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic Intersept Custom Tubing Pack which contain Select 3D or Select CAP Arterial Cannulae. Model 3Y90R3, the following model is onl...
Medical Devices·19,483 affected·Jan 30, 2014
High RiskFDA
Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic Select 3D Arterial Cannulae. Vented, model 78622 (22 Fr.). Non-Vented Cannulae, model 78722 (22 Fr.). Sterilized using Ethy...
Medical Devices·19,483 affected·Jan 30, 2014
CriticalFDA
Gano Excel Usa Inc
Gano C'Real Spirulina, Net Wt. 450g (30gx15 sachets)
Food·27,139 affected·Jan 29, 2014
High RiskFDA
Caraco Pharmaceutical Laboratories Ltd.
Oxcarbazepine Tablets, 300 mg, 100 tablet bottles, Rx Only. Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijiah McCoy...
Oral Drugs·7,005 affected·Jan 29, 2014
Medium RiskFDA
Fougera Pharmaceuticals Inc.
Triamcinolone Acetonide Cream USP, 0.1%, Net Wt 80 grams per tube, Rx only, E. Fougera & Co., A division of Fougera Pharmaceuticals Inc.,...
Topical Drugs·493,192 affected·Jan 29, 2014
High RiskFDA
Pfizer Inc.
GREENSTONE BRAND fluconazole for Oral Suspension, ORANGE FLAVORED, 40 mg/mL, when reconstituted, Rx only, Distributed by Greenstone LLC P...
Oral Drugs·4,155 affected·Jan 29, 2014
High RiskFDA
Implantech Associates Inc
Gelzone Shoulder Sleeve, Catalog Number SLV634, Lot Number 852766. Product Usage: To be used where limb support and/or elevation is...
Medical Devices·300 affected·Jan 29, 2014
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products CDM PROM (Calibration Data Module) No. 0168, Catalog Number/REF 199 9077, used in conjunction with: VITROS Chem...
Diagnostic Devices·284 affected·Jan 29, 2014