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 Healthcare Informatics, Inc.
Philips XRE, the dictation editor system included in the Philips XIRIS 8.1.50 XIRIS is a radiology information system (RIS) is a compu...
Medical Devices·5 affected·May 5, 2014
High RiskFDA
Philips Medical Systems, Inc.
All Philips Ingenia, Intera, Achieva and Multiva MR systems using R5.1i and R5.1 .2 version of software. Indicated for use as a diagnost...
Diagnostic Devices·317 affected·May 5, 2014
High RiskFDA
Mckesson Medical Immaging
Horizon Medical Imaging It is a medical image and information management application that is intended to receive, transmit, store, ret...
Medical Devices·659 affected·May 5, 2014
High RiskFDA
American Importing Co, Inc
Product label: Amport Foods, Granola, Cinnamon Crunch, 22 oz (1 lb, 6 0z), UPC 0 71725 72511 0, Best BY 03-26-15, Ingredients: wheat fl...
Bakery & Grains·229 affected·May 2, 2014
CriticalFDA
Anhing Corporation
Caravelle CHILI POWDER HOT Net Weight 8 oz. (227G), plastic tub, UPC 080736115551. 24 units/case
Food·83 affected·May 2, 2014
High RiskFDA
Bazzini Holdings L.l.c.
Barricini Milk Chocolate Peanut Butter Pretzels in Net Wt 6.5 oz. plastic tub, UPC 075655235181 Back Panel: Milk Chocolate Peanut But...
Dairy·1,000 affected·May 2, 2014
High RiskFDA
Fresenius Kabi Usa, Llc
Fosphenytoin Sodium Injection, USP, 100 mg PE/2 mL (50 mg PE/mL) (PE= phenytoin sodium equivalents) 2 mL Single Use Vial, Rx only, Manuf...
Injectable Drugs·2,070,500 affected·May 2, 2014
High RiskFDA
Fresenius Kabi Usa, Llc
Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL), (PE= phenytoin sodium equivalents) 10 mL Single Use Vial, Rx only, Man...
Injectable Drugs·728,880 affected·May 2, 2014
High RiskFDA
Ge Healthcare, Llc
Kenex Radiation Shield and surgical lamps installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging systems. Kenex S...
Surgical Devices·3,221 affected·May 2, 2014
High RiskFDA
Alere San Diego, Inc.
Alere Triage¿ D-Dimer Test PN 98100, Lot W53884B. The Alere Triage¿ D-Dimer Test is a fluorescence immunoassay to be used with the Aler...
Diagnostic Devices·373 affected·May 2, 2014
High RiskFDA
Medtronic Neuromodulation
Medtronic Model 8780 Ascenda Intrathecal Catheter. The implantable Medtronic Model 8780 Ascenda Intrathecal Catheter is part of an inf...
Medical Implants·1 affected·May 2, 2014
High RiskFDA
Prep Enterprises Llc
Arena Ethnobotanicals and Kratom Pro, sizes: 1oz, 4oz, and 8oz.
Food·4,505 affected·May 1, 2014
High RiskFDA
Pepsi Beverages Company
Lipton Pure Leaf Iced Tea Lemon 18.5OZ PL 12 Pack
Beverages·20,064 affected·May 1, 2014
CriticalFDA
E & M Corporation, Dba Noh Foods International Of Hawaii
Hawaiian Coconut Pudding, Haupia Luau Dessert; Packaged in Net Wt. 2 oz. (57 g); Net wt. 4 oz. (114 g) and Net wt. 48 oz. (3 lb) 1.36 k...
Food·25,458 affected·May 1, 2014
High RiskFDA
Prep Enterprises Llc
CAPTAIN KRATOM GOLD XL 30 Grams MAENG DA CAPSULES CAPTAIN KRATOM GOLD 15 GRAMS MAENG DA CAPSULES CAPTAIN KRATOM PREMIUM THAI POWDER 15 ...
Food·155,470 affected·May 1, 2014
High RiskFDA
Pepsi Beverages Company
Lipton Pure Leaf Iced NTS Peach Tea 12 Pack
Beverages·7,656 affected·May 1, 2014
High RiskFDA
Pepsi Beverages Company
Lipton Pure Leaf Iced Tea Sweet Tea 18.5OZ PL 6 Pack
Beverages·40,524 affected·May 1, 2014
CriticalFDA
Lily Bloom's Kitchen
Lily Bloom's Kitchen Chocolate Coconut Poparoons
Snacks & Candy·1,000 affected·May 1, 2014
High RiskFDA
Pepsi Beverages Company
Lipton Pure Leaf Iced NTS Honey Green Tea 12 Pack
Beverages·11,880 affected·May 1, 2014
High RiskFDA
Pepsi Beverages Company
Lipton Pure Leaf Iced Tea Unsweetened 18.5OZ PL 6 Pack and 12 Pack
Beverages·57,552 affected·May 1, 2014
High RiskFDA
Boehringer Ingelheim Roxane Inc
Calcitriol Oral Solution 1 mcg/mL, 15mL bottle, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-3120-41.
Oral Drugs·5,364 affected·May 1, 2014
High RiskFDA
Teva Pharmaceuticals Usa
Dextroamphetamine Sulfate Tablets, USP, 10 mg, 100-count bottles, Rx only, Barr Laboratories, Inc., Pomona, NY 10970, NDC 0555-0953-02.
Oral Drugs·9,882 affected·May 1, 2014
High RiskFDA
Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics Triathlon Tritanium Patella Inserter, . NON-STERILE Product Usage: The Triathlon Tritanium Patella Inserter is p...
Medical Implants·22 affected·May 1, 2014
High RiskFDA
American Spoon Foods, Inc.
American Spoon¿ Sour Cherry PRESERVES Richer in Fruit (56 Brix) Made in Small Batches Net Wt. 9.5 oz/269g, glass jar INGREDIENTS: Red Tar...
Dairy·2,887 affected·Apr 30, 2014
CriticalFDA
Bacai Inc. Dba Ky Duyen House
Lite Fit USA, For Men & Women, Extreme Fat Burner, Suppresses Appetite, Boosts Metabolism, Limits Fat Absorption, Increases Energy, Preve...
Oral Drugs·14,040 affected·Apr 30, 2014
High RiskFDA
Microport Orthopedics Inc.
PATH(R) THREAD CUP ADAPTOR, REF 2007-0013, Wright Medical Technology, Inc. Orthopaedic surgical instrument.
Surgical Devices·140 affected·Apr 30, 2014
High RiskFDA
Abbott Laboratories
HbA1c Calibrators LN 4P52-02 consists of: 4P52-02 Hemoglobin A1c 1 x 1.6 mL and 1 x 1.6 mL. A1c Calibrators (lyophilized) contain hemoglo...
Diagnostic Devices·183 affected·Apr 30, 2014
High RiskFDA
Varian Medical Systems, Inc.
Varian On-Board Imager Advanced Imaging System. The On-Board Imager device is used for verification of correct patient position in rel...
Medical Devices·32 affected·Apr 30, 2014
High RiskFDA
Mako Surgical Corporation
Robotic Arm Interactive Orthopedic System (RIO)
Medical Devices·249 affected·Apr 30, 2014
High RiskFDA
Agfa Corp.
IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) Service IMPAX. For the creat...
Diagnostic Devices·0 affected·Apr 30, 2014
High RiskFDA
Whole Foods Market Group Inc.
Bolivian Artichoke Salad sold at Whole Foods 10 lb bulk bags, refrigerated
Produce·190 affected·Apr 29, 2014
High RiskFDA
Mercola Group
Organic Cocoa Cassava bars, 1.59 oz (45 g), individually packaged in foil pouches and sold under the Dr. Mercola brand. Sold at retail lo...
Food·98,698 affected·Apr 29, 2014
High RiskFDA
Hk Galleria Wholesale L.p
Yangban Rice Porridge with Abalone, Net Wt. 10.16 oz (288 g), UPC 8 83298 61617 3, 24 cans/case
Food·460 affected·Apr 29, 2014
High RiskFDA
Independent Nutrition Center, Inc.
Red Yeast Rice High Potency Dietary Supplement, 600 mg, packaged in a) 120-count VegeCaps per bottle (UPC 8 01650 02205 9) and b) 500-cou...
Supplements·209 affected·Apr 29, 2014
High RiskFDA
Flawless Beauty Llc
Tatiomax (reduced glutathione/hydrolyzed collagen) powder for injection vials, 1200 mg/200 mg, 10-count vials per box, Manufactured by: S...
Injectable Drugs·0 affected·Apr 29, 2014
High RiskFDA
Flawless Beauty Llc
Sterile Water for Injection, 5 mL ampoules, packaged in 50-count ampoules per box, Manufactured and Distributed by: Euro Med Laboratories...
Injectable Drugs·0 affected·Apr 29, 2014
High RiskFDA
Flawless Beauty Llc
Relumins Advanced Glutathione (lyophilized glutathione/vitamin C) injectable solution, 1500 mg/500 mg, packaged in 8-count vials, 8-count...
Injectable Drugs·0 affected·Apr 29, 2014
High RiskFDA
Flawless Beauty Llc
Laroscorbine Platinium (vitamin C/collagen) injectable I.V. solution, 1 gm/0.35 gm, 5 mL ampoules, packaged in 10-count ampoules per box,...
Injectable Drugs·0 affected·Apr 29, 2014
High RiskFDA
Flawless Beauty Llc
Saluta (reduced glutathione) Powder for Injection, 600 mg/vial, packaged in 10 vials per box, Exclusively Distributed by: QAF Pharmaceuti...
Injectable Drugs·0 affected·Apr 29, 2014
High RiskFDA
Flawless Beauty Llc
Vitamin C (ascorbic acid) Injection, USP, 500 mg per 2 mL, 50 x 2 mL ampoules per box, Manufactured by: TP Drug Laboratories (1969) Co., ...
Injectable Drugs·0 affected·Apr 29, 2014
High RiskFDA
Childrens Medical Ventures
Philips/Children's Medical Ventures Smart Monitor 2 Professional Series infant apnea monitor.
Medical Devices·112 affected·Apr 29, 2014
High RiskFDA
Synthes, Inc.
Synthes ProDisc-C 2.0mm Milling Bit, Synthes 2.0mm Milling Bit HXC, Synthes 2.0mm Milling Bit with 2.35mm x 33.5mm Shaft, and Synthes 2.0...
Medical Implants·6,690 affected·Apr 29, 2014
High RiskFDA
Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic Temporary Pacemaker, Model 5348. Single Chamber External Pulse Generator (EPG) Temporary Pacemaker (AAI/VVI). Used in conju...
Cardiac Devices·16,337 affected·Apr 29, 2014
RecallFDA
Baroody Imports Inc.
Beirut Lift Turnips Pickles, Net Wt. 24.66 oz., 700g, Imported & Distributed By: Baroody Import Inc., 1500 B Main Ave. Clifton, NJ 07011,...
Food·178 affected·Apr 28, 2014
High RiskFDA
Ferring Pharmaceuticals Inc
TEV-TROPIN [somatropin (rDNA origin) for injection] 5 mg (15 IU) 1-count bottle, Rx Only, Manufactured in Israel, Distributed by: Gate Ph...
Injectable Drugs·129,060 affected·Apr 28, 2014
High RiskFDA
T.h. Seafood Inc.
Raw, frozen, vacuum-packaged rock fish (portions, fillets, and whole fish, various sizes).
Seafood·2,000 affected·Apr 25, 2014
High RiskFDA
T.h. Seafood Inc.
Raw, frozen, vacuum-packaged salmon (portions, fillets, and whole fish, various sizes).
Seafood·2,000 affected·Apr 25, 2014
High RiskFDA
T.h. Seafood Inc.
Raw, frozen, vacuum-packaged halibut (portions, fillets, and whole fish of various sizes).
Seafood·2,050 affected·Apr 25, 2014