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
Marksans Pharma Inc.
Ibuprofen Tablets, USP 200 mg, 6 x 6500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured ...
Oral Drugs·205,088,000 affected·Jan 9, 2018
High RiskFDA
Marksans Pharma Inc.
Ibuprofen Tablets, USP 200 mg, 6 x 6500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured ...
Oral Drugs·4,127,500 affected·Jan 9, 2018
High RiskFDA
Marksans Pharma Inc.
Ibuprofen Tablets, USP 400 mg, 6 x 3500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured ...
Oral Drugs·21,584,100 affected·Jan 9, 2018
CriticalFDA
Magellan Diagnostics, Inc.
LeadCare II Blood Lead Analyzer Part Numbers: 70-6760, 70-6529-R, 70-6760-P, 70-6760-R. Intended for in vitro (external) use only.
Medical Devices·6,143 affected·Jan 9, 2018
CriticalFDA
Magellan Diagnostics, Inc.
LeadCare Plus Blood Lead Analyzer Part Number: 82-0001 Intended for the quantitative measurement of lead in a whole blood sample.
Medical Devices·79 affected·Jan 9, 2018
RecallFDA
Riverpoint Medical, Llc
RP RIVERPOINT MEDICAL 18G Brachy Grid B&K(TM) style, REF RPG-18 Product Usage: The Riverpoint Brachytherapy Grid is used during Brach...
Medical Devices·443 affected·Jan 9, 2018
High RiskFDA
Hom'ade Foods
Mary B's Thins , 22 Biscuits, NET WT. 28.3 oz (1LB 12.3 OZ) 810g
Food·562,302 affected·Jan 8, 2018
High RiskFDA
Hom'ade Foods
Mary B's Butter Taste, 20 Biscuits, Value Pack, NET WT. 44 oz (2LB 12 OZ)1247g; and Mary B's Butter Taste, 30 Biscuits, Family Pack, NET ...
Dairy·562,302 affected·Jan 8, 2018
CriticalFDA
Gilster-mary Lee Corp.
Coat & Bake, Original Chicken, Seasoned Coating Mix For Chicken, Net Wt 5.5 OZ (156 g), Distributed by SuperValu Inc., Eden Prairie, MN.
Meat & Poultry·240 affected·Jan 8, 2018
High RiskFDA
Hom'ade Foods
Mary B's Jumbo, 10 Biscuits, Extra Large, NET WT. 35 oz (2LB 3OZ) 992g
Food·562,302 affected·Jan 8, 2018
High RiskFDA
Hom'ade Foods
Mary B's Buttermilk, 12 Biscuits, NET WT. 26.4 oz (1LB 10.4OZ) 748g; Mary B's Buttermilk, 20 Biscuits, Value Pack, NET WT. 44 oz (2LB 12...
Dairy·562,302 affected·Jan 8, 2018
High RiskFDA
Hom'ade Foods
Mary B's Buttermilk 0 Trans Fat 220 CT, Bulk Biscuits
Dairy·562,302 affected·Jan 8, 2018
High RiskFDA
Hom'ade Foods
Mary B's Southern Made, 12 Biscuits, NET WT. 26.4 oz (1LB 10.4OZ) 748g; Mary B's Southern Made, 20 Biscuits, Value Pack, NET WT. 44 oz (2...
Food·562,302 affected·Jan 8, 2018
High RiskFDA
Hom'ade Foods
Mary B's Made with Whole Grain, 220CT, Bulk Biscuits
Food·562,302 affected·Jan 8, 2018
High RiskFDA
Innovasis, Inc
Excella II Polyaxial Pedicle Screw used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization an...
Medical Devices·1,010 affected·Jan 8, 2018
High RiskFDA
Mom's Delicious Kitchen Llc
Kvas, a fermented non-alcoholic drink, packaged in a gallon plastic jugs The label is read in parts: "***Mom's Kvas***1 Gallon***Ingre...
Beverages·0 affected·Jan 5, 2018
CriticalFDA
H.i.g. Corporation
Frozen Tuna Fillet Saku (Restaurant Supply Only); 22 lbs./2 x 5 kgs. Wild caught: Handline with Hook. Keep Frozen - 18 degrees C or ...
Seafood·522 affected·Jan 5, 2018
CriticalFDA
Advanced Pharma Inc.
MAGnesium 2 gm in NS 100 mL Magnesium SULfate (USP) 0.9% Sodium Chloride (USP) in 100 mL Sterile single dose bag, Rx only, Avella of Hou...
Drugs·25 affected·Jan 5, 2018
RecallFDA
Diamedix Corporation
Diamedix Is-Mumps IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-540
Diagnostic Devices·505 affected·Jan 5, 2018
RecallFDA
Diamedix Corporation
Diamedix Is-EBV-EA-D IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-640
Diagnostic Devices·147 affected·Jan 5, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
AXIOM Artis angiographic x-ray system, Model Numbers: 7412807, 7413078, 7728392 AXIOM Artis is a family of dedicated angiography syst...
Diagnostic Devices·22 affected·Jan 5, 2018
CriticalFDA
Dollar General Corporation, Inc.
Clover Valley¿ Iced Oatmeal Cookies NET WT 12 OZ (340 g) CONTAINS: WHEAT, SOY. DISTRIBUTED BY DOLGENCORP, LLC 100 MISSION RIDGE GOODLETTS...
Bakery & Grains·77,632 affected·Jan 4, 2018
CriticalFDA
International Laboratories, Llc
Clopidogrel Tablets, USP 75 mg, 30-count bottles, Rx only, Packaged for: International Laboratories, LLC St. Petersburg, FL 33710, NDC ...
Oral Drugs·218,772 affected·Jan 4, 2018
CriticalFDA
Philips Electronics North America Corporation
Allura Xper systems with Certeray X-ray Generator located in regions with high mains (480V) voltage. Product Usage: The Allura Xper s...
Medical Implants·705 affected·Jan 4, 2018
High RiskFDA
Biomerieux, Inc.
BioMerieux VIDAS System in combination with Quality Control VIDAS* (QCV*) Product Usage: the Quality Control VIDAS (QCV) is an automa...
Diagnostic Devices·1,866 affected·Jan 4, 2018
High RiskFDA
Toshiba American Medical Systems Inc
Diagnostic Ultrasound System, Aplio I-series. Labeled as i700, i800, i900 The power supply unit may be damaged and may fail to start ...
Diagnostic Devices·162 affected·Jan 4, 2018
CriticalFDA
Fieldbrook Foods Corporation
RASPBERRY Cream Ice Cream Bars: Sundae SHOPPE, 12 Bars, UPC 041498204631
Dairy·639,900 affected·Jan 3, 2018
CriticalFDA
Fieldbrook Foods Corporation
Chocolate Covered Vanilla Ice Cream Bars packaged under the following brands: 12 packs - Ahold UPC: 6 88267 03323 5 and different ICB: 6...
Dairy·639,900 affected·Jan 3, 2018
CriticalFDA
Fieldbrook Foods Corporation
Orange Cream Ice Cream Bars sold under the following labels: Sold in a 12-pack: Ahold UPC: 6 88267 03292 9, Econo UPC: 7 08938 00610 ...
Dairy·639,900 affected·Jan 3, 2018
CriticalFDA
Fieldbrook Foods Corporation
Ice Cream Variety Packs containing Sandwiches, Bars, and Cones, Sold under the following: 30 pack - pics BY PRICE CHOPPER - UPC: 04173508...
Dairy·639,900 affected·Jan 3, 2018
High RiskFDA
Avkare Inc.
Lovastatin Tablets USP, 40 mg, 50 Tablets (5x10) Unit Dose carton, Rx only, Manufactured for AvKARE, Inc. Pulaski, TN 38478, NDC 50268-51...
Oral Drugs·237 affected·Jan 3, 2018
High RiskFDA
Medtronic Perfusion Systems
Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures.
Surgical Devices·2,914 affected·Jan 3, 2018
High RiskFDA
Getinge Us Sales Llc
HEMASHIELD Knitted Double Velour Cardiovascular Fabric
Medical Devices·1 affected·Jan 3, 2018
High RiskFDA
Philips Electronics North America Corporation
Intellivue iX Information Center Software - All PIIC iX Surveillance stations including: 866023 IntelliVue Info Center iX A.0 866117 PI...
Medical Devices·20,357 affected·Jan 3, 2018
High RiskFDA
Esaote S.p.a.
MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; Probes: BL433, C 18, CA541, EC1123, EC123, IH 618, IOT332, IOT342, L 415, LA332E,...
Medical Devices·5 affected·Jan 3, 2018
CriticalFDA
Condies Foods, Inc.
Condies Foods Fresh Fruit, Item Number 40781, UPC 50777222655
Produce·166 affected·Jan 2, 2018
CriticalFDA
Productos Pacheco, Inc.
Pound Cake NET WT 4OZ and 12OZ.
Bakery & Grains·0 affected·Jan 2, 2018
CriticalFDA
Productos Pacheco, Inc.
Mallorca Queso NET WT 4OZ
Food·0 affected·Jan 2, 2018
CriticalFDA
Productos Pacheco, Inc.
Bizcocho de Vainilla con Queso [Vanilla Cake with Cheese] NET WT 4OZ and 12OZ
Dairy·0 affected·Jan 2, 2018
CriticalFDA
Productos Pacheco, Inc.
Pan [bread] NET WT 1LB (16OZ)
Bakery & Grains·0 affected·Jan 2, 2018
CriticalFDA
Productos Pacheco, Inc.
Bizcocho Zanahoria [Carrot Cake] NET WT 4OZ
Bakery & Grains·0 affected·Jan 2, 2018
CriticalFDA
Productos Pacheco, Inc.
Bizcocho de Vainilla con Guava [Vanilla Cake with Guava] NET WT 4OZ and 12OZ
Bakery & Grains·0 affected·Jan 2, 2018
CriticalFDA
Productos Pacheco, Inc.
Bizcocho Maiz [Corn Cake] NET WT 4OZ
Bakery & Grains·0 affected·Jan 2, 2018
RecallFDA
Vinh Sanh Trading Corp
Wahon Slice Shitake Mushroom 2.5 oz. (71g) UPC : #737483336851
Food·141 affected·Jan 2, 2018
CriticalFDA
Productos Pacheco, Inc.
Pan con pasas [Bread with raisins] NET WT 1LB (16OZ)
Bakery & Grains·0 affected·Jan 2, 2018
CriticalFDA
Evershing International Trading Inc.
Coconut Tree Brand Shredded Coconut; frozen Dua Bao; Net WT. 16 oz. (454 g); Product of Vietnam; UPC 05216-44081 Ingredient: Coconu...
Frozen Food·4,377 affected·Jan 2, 2018
CriticalFDA
Productos Pacheco, Inc.
Polvorones NET WT 4OZ
Food·0 affected·Jan 2, 2018
CriticalFDA
Productos Pacheco, Inc.
Mallorcas Pacheco NET WT 1LB (16OZ)
Food·0 affected·Jan 2, 2018