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
Mckesson Israel Ltd.
McKesson Cardiology Hemo, Release SW version 13.0. Used for physiological monitoring, image and data processing. McKesson Cardiology...
Medical Devices·31 affected·Mar 12, 2018
High RiskFDA
Schwartz Brothers Restaurants Dba Schwartz Brothers Bakery
Gourmet Cream Cheese Cinnamon Rolls, packaged in a 16 oz. plastic clam shell container and sold under the Schwartz Brothers Bakery brand....
Dairy·106 affected·Mar 11, 2018
High RiskFDA
Richard Wolf Gmbh
RICHARD WOLF TUBE SET FOR TEM, REF 4170.801. Used for the transanal endoscopic microsurgery.
Medical Devices·1,710 affected·Mar 11, 2018
High RiskFDA
Maplehurst Bakeries, Llc.
ITALIAN BREAD, SKU: 10424, Frozen Dough
Bakery & Grains·960 affected·Mar 10, 2018
CriticalFDA
Wegmans Food Markets, Inc.
Wegmans Assorted Gyoza (Dumplings), Family Pack, 17 oz. UPC: 2-48798-00000 or 2-48963-00000 packaged with Wegmans Thai Sweet Chili Sauc...
Food·31 affected·Mar 10, 2018
CriticalFDA
Wegmans Food Markets, Inc.
Wegmans Avocado Summer Roll, 2 Pack, 5 oz. UPC: 2-48762-00000 or 2-48920-00000 packaged with Wegmans Thai Sweet Chili Sauce Cup 1.5 oz. (...
Food·577 affected·Mar 10, 2018
CriticalFDA
Lancaster Fine Foods Inc.
1.5 oz. cup with seal on label reading: Thai Sweet Chili Sauce; Ingredients: Thai Sweet Chili Sauce (Sugar, Water, Pickled Red Chili, Vi...
Beverages·267 affected·Mar 10, 2018
CriticalFDA
Wegmans Food Markets, Inc.
Wegmans Thai Sweet Chili Sauce Cup 1.5 oz. (UPC 7-66630-98023)
Food·262 affected·Mar 10, 2018
High RiskFDA
Maplehurst Bakeries, Llc.
RAISIN BREAD, SKU: 10460, Frozen Dough
Bakery & Grains·60 affected·Mar 10, 2018
High RiskFDA
Maplehurst Bakeries, Llc.
100% WHOLE WHEAT BREAD DOUGH, SKU: 11895, Frozen
Bakery & Grains·120 affected·Mar 10, 2018
CriticalFDA
Pdx Aromatics
RED Kratom CAPSULES, sold under brand names Kraken Kratom, Phytoextractum, and Soul Speciosa. The capsules are packaged in plastic he...
Food·10,210 affected·Mar 9, 2018
CriticalFDA
Avalon Packaging
NXTGEN Botanicals, Maeng Da Kratom, Dietary Supplement, 70 Capsules, Made in the U.S.A
Supplements·1,108 affected·Mar 9, 2018
High RiskFDA
Oregon Food Bank
Chia Seeds packaged in poly film bags as both a twist type closure and a re-sealable pouch, net wt. 1 lb.
Food·22,201 affected·Mar 9, 2018
CriticalFDA
Pdx Aromatics
GREEN Kratom CAPSULES, sold under brand names Kraken Kratom, Phytoextractum, and Soul Speciosa. The capsules are packaged in plastic ...
Food·3,197 affected·Mar 9, 2018
High RiskFDA
Nestle Dreyers Ice Cream Company
Dreyer's Slow Churned Vanilla Bean Ice Cream; 1.5 qt, (48-fl oz.); Lid is for Dreyer's Slow Churned Butter Pecan Ice Cream UPC 41548...
Dairy·30 affected·Mar 9, 2018
CriticalFDA
Pdx Aromatics
WHITE VEIN Kratom POWDER, sold under brand names Kraken Kratom, Phytoextractum, and Soul Speciosa. The powder is packaged in plastic heat...
Food·4,676 affected·Mar 9, 2018
CriticalFDA
Pdx Aromatics
GREEN Kratom POWDER, sold under brand names Kraken Kratom, Phytoextractum, and Soul Speciosa. The powder are packaged in plastic heat...
Food·20,546 affected·Mar 9, 2018
CriticalFDA
Pdx Aromatics
RED Vein Kratom POWDER, sold under brand names Kraken Kratom, Phytoextractum, and Soul Speciosa. The powder is packaged in plastic heat s...
Food·18,572 affected·Mar 9, 2018
CriticalFDA
Pdx Aromatics
WHITE VEIN Kratom CAPSULES, sold under brand names Kraken Kratom, Phytoextractum, and Soul Speciosa. The capsules are packaged in pla...
Food·1,097 affected·Mar 9, 2018
Medium RiskFDA
Alva-amco Pharmacal Companies., Inc.
Psoriasin Daytime Relief Cream with Vitamin D & Oatmeal, (Coal Tar 1.25%), packagedin 57 g plastic tubes, Distributed by: ALVA-AMCO Pharm...
Topical Drugs·206,513 affected·Mar 9, 2018
RecallFDA
Akorn, Inc.
Triamcinolone Acetonide Lotion, USP 0.1%, 60 mL bottle, Rx Only, Marketed by: VersaPharm Incorporated, Marietta, GA 30062; Manufactured b...
Drugs·4,128 affected·Mar 9, 2018
High RiskFDA
The Binding Site Group, Ltd.
Binding Site Optilite Beta-2-Microglobulin Urine Kit, Ref LK043.L.OPT.A, IVD. The firm name on the label is The Binding Site Group Ltd.,...
Medical Devices·20 affected·Mar 9, 2018
High RiskFDA
Stryker Medical Division Of Stryker Corporation
6381 M-1 Cot Fastener, catalog no. 6381000000
Medical Devices·3 affected·Mar 9, 2018
High RiskFDA
Hamilton Medical Ag
Hamilton-C3 Ventilator Unit Product Usage: The HAMILTON-C3 ventilator is intended to provide positive pressure ventilator support to ...
Respiratory Devices·2 affected·Mar 9, 2018
High RiskFDA
Hamilton Medical Ag
Hamilton-C1 Ventilator Unit Product Usage: The HAMILTON-C1 ventilator is intended to provide positive pressure ventilation support to...
Respiratory Devices·16 affected·Mar 9, 2018
High RiskFDA
Adm Agri Industries
Provim ESP Vita Wheat Gluten, Product code 6303, 50 lb bag
Food·6,080 affected·Mar 8, 2018
RecallFDA
Dr. Reddy's Laboratories, Inc.
Clocortolone Pivalate Cream, 0.1%, 90-gram tube, Rx only, Distributed by: Dr. Reddy's Laboratories, Inc. Princeton, NJ 08540, Manufacture...
Topical Drugs·4,152 affected·Mar 8, 2018
High RiskFDA
Bracco Diagnostics Inc.
E-Z-Paste Barium Sulfate Esophageal Cream (60% w/w), 454 g tube, Rx only, Manufactured by E-Z-EM Canada Inc. for E-Z-EM Inc. a subsidiar...
Topical Drugs·2,136 affected·Mar 8, 2018
CriticalFDA
Jimmy Weber
Red Zone Xtreme 3000 Capsules, Dietary Supplement Product, 1 count blister pack, UPC 8 91656 00200 9, Exp Date 12/31/2021
Oral Drugs·315 affected·Mar 8, 2018
High RiskFDA
Southern Implants, (pty.) Ltd.
SOUTHERN IMPLANTS REF IBR12d-13, Implant, Ext. Hex, tapered 12o Co-Axis(TM) intended for surgical placement in the upper or lower jaw to ...
Medical Implants·49 affected·Mar 8, 2018
High RiskFDA
Oregon Wild Berries, Inc.
Mushroom Condensed Soup, brand Chef Edwin's, packaged in glass pint Kerr jars, Net wt. 14 oz. UPC 7 00424 66845 8. The product label ...
Produce·123 affected·Mar 7, 2018
High RiskFDA
Apollo Care
Vancomycin 1.25g added to 250 mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare, 3801 Mojave Ct., Suite 101, Columbia, MO 65202, NDC...
Injectable Drugs·96 affected·Mar 7, 2018
High RiskFDA
American Pharmaceutical Ingredients Llc
Oxytocin USP, powder, 1g-bottle, API American Pharmaceutical Ingredients, NDC 58597-7042-3
Drugs·21 affected·Mar 7, 2018
High RiskFDA
Apollo Care
Vancomycin 1g added to 250mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare, 3801 Mojave Ct., Suite 101, Columbia, MO 65202, NDC 711...
Injectable Drugs·144 affected·Mar 7, 2018
High RiskFDA
American Pharmaceutical Ingredients Llc
Sermorelin Acetate, powder, a) 1 GM-bottle (NDC58597-8092-1) b) 5 GM-bottle (NDC 58597-8092-2) c) 10 GM-bottle (NDC 58597-8092-4) API Ame...
Drugs·1,460 affected·Mar 7, 2018
High RiskFDA
Ethicon, Inc.
Evicel Accessory Device - 45 cm Flexible Tip (SET OF 3), Product Code EVT45. Accessory Tips for use only with EVICEL Fibrin Sealant (Hum...
Medical Devices·738 affected·Mar 7, 2018
High RiskFDA
Intuitive Surgical, Inc.
da Vinci X Surgical System, Model IS4200. Product Usage: The Intuitive Surgical Endoscopic Instrument Control System (da Vinci X Surg...
Cardiac Devices·108 affected·Mar 7, 2018
High RiskFDA
Sps Sterilization, Inc
Edwards Lifesciences Avid Dual Stage Venous Drainage Cannula, 29/37F (9.6/12.3MM) X 37CM (14.5"), resterilized.
Medical Devices·5 affected·Mar 7, 2018
High RiskFDA
Sps Sterilization, Inc
Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 34F (11.3MM) X 40CM (16"), resterilized.
Medical Devices·5 affected·Mar 7, 2018
High RiskFDA
Smith & Nephew, Inc.
D-RAD Self-Tapping Locking Screw intended for the fixation of fractures involving the distal radius. smith&nephew D-RAD 2.4MM X 10MM S-T ...
Medical Devices·59 affected·Mar 7, 2018
High RiskFDA
Sps Sterilization, Inc
Boston Scientific Wallstent Endoprosthesis Tracheobronchial Transhepatic Biliary Self-Expanding Stent, 12MM X 90MM | 75CM L, resterilized.
Medical Implants·2 affected·Mar 7, 2018
High RiskFDA
Sps Sterilization, Inc
Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 38FRX40CM, resterilized.
Medical Devices·10 affected·Mar 7, 2018
High RiskFDA
Sps Sterilization, Inc
Boston Scientific Wallstent Enteral Endoprosthesis Colonic/Duodenal Stent, 22MM X 90MM, resterilized.
Medical Implants·2 affected·Mar 7, 2018
High RiskFDA
Autochair
Product: Milford Smartbase Model # 9934105 Pride SmartBase Pride product codes: LSMPLCG A & LSMPLCG B
Medical Devices·0 affected·Mar 7, 2018
High RiskFDA
Sps Sterilization, Inc
Boston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding Stent, 24MM X 70MM | 75CM L, resterilized.
Medical Implants·2 affected·Mar 7, 2018
High RiskFDA
Sps Sterilization, Inc
Boston Scientific Wallstent RP Endoprosthesis Tracheobronchial Transhepatic Biliary Self-Expanding Stent, 8MM X 80MM | 75CM, resterilized.
Medical Implants·2 affected·Mar 7, 2018
High RiskFDA
Sps Sterilization, Inc
Vascular Solutions Venture Rx Catheter, 6F, resterilized.
Surgical Devices·3 affected·Mar 7, 2018
CriticalFDA
Starwest Botanicals, Inc
Cardamom Pods Green Whole Organic Sold in 25 lb. bulk boxes and 1 lb. retail plastic bags UPC 1 pound bags: 7-6796302528-9; UPC b...
Food·810 affected·Mar 6, 2018