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
Koogee-queen Anne, Llc
Blue Cheese Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Dairy·3 affected·Apr 10, 2014
High RiskFDA
The Pastene Companies Ltd.
Pastene ITALIAN DITALI #45 , 16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:708...
Food·6,000 affected·Apr 10, 2014
High RiskFDA
Koogee-queen Anne, Llc
Cherry Amaretto Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Dairy·1 affected·Apr 10, 2014
High RiskFDA
Koogee-queen Anne, Llc
Chocolate Coconut Almond Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Dairy·3 affected·Apr 10, 2014
High RiskFDA
The Pastene Companies Ltd.
Pastene ITALIAN ORECCHIETTE ,16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:7097...
Food·6,000 affected·Apr 10, 2014
High RiskFDA
Koogee-queen Anne, Llc
Rocky Road Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Dairy·1 affected·Apr 10, 2014
RecallFDA
Harvest Sensations Llc
Verdex Fresh Snow Peas packed in 10 pounds cartons, keep refrigerated, Lot # 2161100811 product from Guatemala
Food·915 affected·Apr 10, 2014
High RiskFDA
The Pastene Companies Ltd.
Pastene ITALIAN LINGUINE #6, 16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:...
Food·6,000 affected·Apr 10, 2014
High RiskFDA
The Pastene Companies Ltd.
Pastene ITALIAN STELLINE #59 , 16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number...
Food·6,000 affected·Apr 10, 2014
High RiskFDA
The Pastene Companies Ltd.
Pastene FARFALLINE 78, 16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number: 7067 UP...
Food·6,000 affected·Apr 10, 2014
High RiskFDA
Koogee-queen Anne, Llc
Vanilla Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Dairy·20 affected·Apr 10, 2014
High RiskFDA
The Pastene Companies Ltd.
Pastene MAFALDINE 5, 16 oz cellophane bag Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number: 7062 UPC: 066...
Food·6,000 affected·Apr 10, 2014
High RiskFDA
Koogee-queen Anne, Llc
Bourbon Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Dairy·5 affected·Apr 10, 2014
High RiskFDA
The Pastene Companies Ltd.
Pastene ITAL NIDI #81 ,16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:7090 UPC...
Food·6,000 affected·Apr 10, 2014
High RiskFDA
Koogee-queen Anne, Llc
Chocolate Bourbon Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Dairy·2 affected·Apr 10, 2014
High RiskFDA
Koogee-queen Anne, Llc
Watermelon Sorbet, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Beverages·1 affected·Apr 10, 2014
High RiskFDA
Koogee-queen Anne, Llc
Coconut Almond White Chocolate Dream Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisvil...
Dairy·3 affected·Apr 10, 2014
High RiskFDA
Koogee-queen Anne, Llc
Simply Southern Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Dairy·14 affected·Apr 10, 2014
High RiskFDA
Koogee-queen Anne, Llc
Vermont Maple Walnut Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Dairy·13 affected·Apr 10, 2014
High RiskFDA
Koogee-queen Anne, Llc
Georgia Butter Pecan Ice Cream and Simply Southern Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort...
Dairy·3 affected·Apr 10, 2014
High RiskFDA
Koogee-queen Anne, Llc
Hey Jude Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Dairy·4 affected·Apr 10, 2014
High RiskFDA
Koogee-queen Anne, Llc
Gin and Juice Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Dairy·1 affected·Apr 10, 2014
High RiskFDA
Koogee-queen Anne, Llc
Tiramisu Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Dairy·1 affected·Apr 10, 2014
High RiskFDA
Koogee-queen Anne, Llc
Pistachio Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
Dairy·1 affected·Apr 10, 2014
High RiskFDA
Bausch & Lomb, Inc.
Sodium Chloride Hypertonicity Ophthalmic Ointment, 5%, 1/8 oz. (3.5 g) tube per carton, Distributed by Major Pharmaceuticals, 31778 Enter...
Topical Drugs·35,253 affected·Apr 10, 2014
High RiskFDA
Bausch & Lomb, Inc.
Muro 128 (sodium chloride) hypertonicity ophthalmic ointment, 5%, packaged in a) 1 g tube per carton, professional sample, NDC 24208-385-...
Topical Drugs·4,165 affected·Apr 10, 2014
High RiskFDA
Wockhardt Usa Inc.
Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100-count bottle, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India;...
Oral Drugs·8,712 affected·Apr 10, 2014
High RiskFDA
Ortho-clinical Diagnostics
VITROS 5,1 FS Chemistry System and VITROS 5,1 FS Refurbished, Product Codes/Catalog Numbers 6801375, 6801890 for in vitro diagnostic use.
Diagnostic Devices·597 affected·Apr 10, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Systems VitD Total 100 test, Ready Pack, For OUS; SMN 10699201. Intended for the invitro diagnostic use in quantitativ...
Diagnostic Devices·40,266 affected·Apr 10, 2014
High RiskFDA
Ortho-clinical Diagnostics
enGen Laboratory Automation Systems (enGen) with TCAutomation -- For in vitro quantitative measurement of a variety of analytes of clin...
Diagnostic Devices·31 affected·Apr 10, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Systems VitD 500 test, Ready Pack, Catalog Number: 10631021. Intended for the invitro diagnostic use in quantitative ...
Diagnostic Devices·12,787 affected·Apr 10, 2014
High RiskFDA
Ortho-clinical Diagnostics
VITROS 5600 Integrated System, Product Code/Catalog Number 6802413 for in vitro diagnostic use.
Diagnostic Devices·835 affected·Apr 10, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Systems TSH3 Ultra , Ready Pack, 500 test Catalog Number: 06491080; Siemens Material Number: 10282379. Intended for the...
Diagnostic Devices·155,345 affected·Apr 10, 2014
High RiskFDA
Ortho-clinical Diagnostics
VITROS 4600 Chemistry System, Product Code/Catalog Number 6802445 for in vitro diagnostic use.
Diagnostic Devices·82 affected·Apr 10, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Systems BRAHMS PCT 100 test Sold only OUS; Catalog Number: 10378883.
Medical Devices·16,302 affected·Apr 10, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Systems TSH3 Ultra Ready Pack, 100 test Catalog Number: 06491072; Siemens Material Number: 10282378. Intended for the ...
Diagnostic Devices·22,770 affected·Apr 10, 2014
High RiskFDA
Synthes, Inc.
Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixation appliance components.
Medical Devices·5,114,052 affected·Apr 10, 2014
CriticalFDA
Smiths Medical Asd, Inc.
Portex Low Dead Space Connector with Sideport, 3.5mm Product Usage: The connector is used to attach the endotracheal tube to the pati...
Medical Devices·100 affected·Apr 10, 2014
CriticalFDA
Fernandez Chile Company, Incorporated
Fernandez True Chile Flavor, Mild Chile Rojo, 6 oz.
Food·279 affected·Apr 9, 2014
CriticalFDA
Karl Bissinger Llc
Bissinger's Dark Chocolate Bunny Ears, 1 oz, individually wrapped in clear plastic with an ingredient card insert and packaged in a 24-ct...
Snacks & Candy·10,363 affected·Apr 9, 2014
CriticalFDA
Fernandez Chile Company, Incorporated
Fernandez True Chile Flavor, Medium Hot Chile Molido Puro, 4 oz.
Food·721 affected·Apr 9, 2014
Medium RiskFDA
Caraco Pharmaceutical Laboratories, Ltd.
Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count bottle, OTC Manufactured by Sun Pharma, Gujarat, India, NDC 47335-343-83
Oral Drugs·128,363 affected·Apr 9, 2014
RecallFDA
Caraco Pharmaceutical Laboratories, Ltd.
Children's Cetirizine Hydrochloride Chewable Tablets, 10 mg, 30 count bottle, OTC, Manufactured by Sun Pharma, Gujarat, India, Distribu...
Oral Drugs·47,813 affected·Apr 9, 2014
High RiskFDA
Legacy Pharmaceutical Packaging
Pantoprazole Sodium, Delayed-release tablets, USP, 40 mg tablets, 100 (10x10) unit dose packages, Manufactured by Dr. Reddy's Laboratorie...
Oral Drugs·0 affected·Apr 9, 2014
High RiskFDA
Caraco Pharmaceutical Laboratories, Ltd.
Gemcitabine For Injection USP, 1 g, (lyophilized), For Intravenous Use Only, Sterile Single Use Vial, Rx only, Manufactured by: Sun Pharm...
Injectable Drugs·200 affected·Apr 9, 2014
CriticalFDA
Nature's Universe
THINOGENICS, WEIGHT LOSS MADE EASY! DIETARY SUPPLEMENT, 30 CAPSULES, 30 Count Bottles, THINOGENICS LLC, Nashville, TN 37203 USA.
Oral Drugs·0 affected·Apr 9, 2014
High RiskFDA
Edwards Lifesciences, Llc
Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae, arterial cannula sizes 16, 18 and 20 French, models: FEMII016A, FEMII01...
Medical Devices·13,115 affected·Apr 9, 2014
High RiskFDA
Ev3, Inc.
ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 120mm x 135cm, REF: AB35W06120135. and ev3 EverCross 0.035" OTW PTA Dilatatio...
Surgical Devices·39 affected·Apr 9, 2014