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
Roche Molecular Systems, Inc.
LightMix¿ Zika rRT-PCR Test The LightMix¿ Zika rRT-PCR Test is a real-time RT-PCR test intended for the qualitative detection of RNA fro...
Diagnostic Devices·24 affected·Nov 16, 2016
High RiskFDA
Smith & Nephew, Inc.
REFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116
Medical Devices·4,444 affected·Nov 16, 2016
RecallFDA
Perkinelmer Health Sciences, Inc.
DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum
Diagnostic Devices·79 affected·Nov 16, 2016
High RiskFDA
Medtronic Inc
Affinity Fusion" Oxygenator with Integrated Arterial Filter, Affinity Fusion cardiotomy/Venous Reservoir, Perfusion Tubing Packs The...
Respiratory Devices·5,609 affected·Nov 16, 2016
CriticalFDA
4 C Foods, Corp.
4C Homestyle All Natural Parmesan Grated Cheese, UPC 41387-32790, 6 oz
Dairy·1,122,617 affected·Nov 15, 2016
CriticalFDA
4 C Foods, Corp.
4C All Natural Parmesan Grated Cheese, UPC 41387-33126, 6 oz
Dairy·1,122,617 affected·Nov 15, 2016
CriticalFDA
4 C Foods, Corp.
4C Homestyle All Natural Parmesan/Romano Grated Cheese, UPC 41387-11627, 6 oz
Dairy·1,122,617 affected·Nov 15, 2016
CriticalFDA
4 C Foods, Corp.
4C All Natural 100% Imported Italian Pecorino Romano Cheese, UPC 41387-77126, 6 oz
Dairy·1,122,617 affected·Nov 15, 2016
CriticalFDA
4 C Foods, Corp.
Cento Parmesan Grated Cheese, UPC 70796-90502, 6 oz
Dairy·1,122,617 affected·Nov 15, 2016
CriticalFDA
4 C Foods, Corp.
4C Homestyle All Natural 100% Imported Italian Pecorino Romano Cheese, UPC 41387-12302, 6 oz
Dairy·1,122,617 affected·Nov 15, 2016
CriticalFDA
Wd Import And Export Inc.
DRIED SILVER FISH, N.W. 30 LBS, PRODUCT OF CHINA
Seafood·710 affected·Nov 15, 2016
CriticalFDA
Request Foods Inc.
GFS Cheese Manicotti in tomato sauce. retail 68 oz. pan. 4 retail units per case
Dairy·1,592 affected·Nov 15, 2016
High RiskFDA
Seely Family Farm
Spearmint candy canes, Net wt. 1.4 oz. The UPC is 8 54502 00321 8
Snacks & Candy·900 affected·Nov 15, 2016
CriticalFDA
4 C Foods, Corp.
4C All Natural Parmesan/Romano Grated Cheese, UPC 41387-37126, 6 oz
Dairy·1,122,617 affected·Nov 15, 2016
High RiskFDA
Encore Medical, Lp
Empowr Knee System Product Usage: Non-porous proximal tibial baseplate implants, utilized in either posterior cruciate ligament (PCL)...
Medical Implants·7 affected·Nov 15, 2016
High RiskFDA
Robert Busse & Co. Inc. D.b.a. Busse Hospital Disposables
CARPAL TUNNEL PACK, Surgical Instrument Tray, REF/Catalog No. 3366, STERILE, Rx Only -- busse Hospital Disposables Hauppauge, NY --- Dev...
Surgical Devices·14 affected·Nov 15, 2016
High RiskFDA
Smith & Nephew, Inc.
Modular Necks: The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for individuals undergoing primary and revision surg...
Medical Implants·13,671 affected·Nov 15, 2016
High RiskFDA
Robert Busse & Co. Inc. D.b.a. Busse Hospital Disposables
SET UP PACK Surgical Instrument Tray, REF/Catalog No. 6250R1, STERILE, Rx Only --- busse Hospital Disposables Hauppauge, NY --- Device Li...
Surgical Devices·82 affected·Nov 15, 2016
High RiskFDA
Smith & Nephew, Inc.
Modular REDAPT(TM) Hip Systems The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for individuals undergoing primary...
Medical Implants·6,266 affected·Nov 15, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Definition Edge System, x-ray, tomography, computed Intended to produce cross-sectional images of the body by computer reconstru...
Medical Devices·104 affected·Nov 15, 2016
High RiskFDA
Implant Direct Sybron Manufacturing, Llc
ImplantDirect Legacy 4 Implant, 5.7mmD x 5.7mmD Platform, Part 885708, Rx, Sterile. The incorrect cap label shows part 855708, 5.7mmD Pl...
Medical Implants·18 affected·Nov 15, 2016
CriticalFDA
The Popcorn Shoppe
The Popcorn Shoppe Popcorn Balls (4) 5 oz balls, sold under the brand names of Olde Tyme Recipe, Edwards Orchards & Edwards Orchards West.
Snacks & Candy·156 affected·Nov 14, 2016
High RiskFDA
Akorn Inc
Desoximetasone Ointment USP, 0.25%, a) 15 g tubes (NDC 61748-206-15 and b) 60 g tubes (NDC 61748-206-60, Marketed by Versapharm Inc., An ...
Topical Drugs·62 affected·Nov 14, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
Philips Spectral CT Applications supports viewing and analysis of images at energies selected from the available spectrum in order to pro...
Medical Devices·20 affected·Nov 14, 2016
CriticalFDA
Ultimate Body Tox
Ultimate Body Tox PRO capsules, Proprietary Blend, 350 mg, 45 count bottle, Manufactured for: JSN Health, 305 Broadway, 7th Floor, New Yo...
Oral Drugs·25 affected·Nov 13, 2016
CriticalFDA
Kraft Heinz Foods Company
Weight Watchers Smart Ones, Chocolate Chip Cookie Dough Sundae, Keep Frozen, 4 Individual Sundaes, 4-2.11 OZ (60g), NET WT. 8.44 OZ (239g)
Bakery & Grains·99,492 affected·Nov 12, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance 64 728231 Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction...
Medical Devices·184 affected·Nov 12, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity Core 728321 Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstructio...
Medical Devices·337 affected·Nov 12, 2016
CriticalFDA
Cedar Crest Specialties, Inc.
Cedar Crest Monster Cookie Dough Ice Cream in 3 Gallon container.
Dairy·10,661 affected·Nov 11, 2016
CriticalFDA
Cedar Crest Specialties, Inc.
Cedar Crest Chocolate Chip Cookie Dough Ice Cream packaged in the following sizes: Pint, 1.5 Quarts, and 3 Gallon
Dairy·10,661 affected·Nov 11, 2016
CriticalFDA
House Of Flavors, Inc.
Ashby's Sterling Peanut Butter Landslide Ice Cream, 3 gallon container, frozen
Dairy·659 affected·Nov 11, 2016
CriticalFDA
Cedar Crest Specialties, Inc.
Cedar Crest Pirate's Bounty Ice Cream 1.5 quarts (1419 mL)
Dairy·10,661 affected·Nov 11, 2016
RecallFDA
First Source, Llc
Wegmans Milk Chocolate Covered Pretzels, NET WT 9.5 OZ (269g)
Dairy·400 affected·Nov 11, 2016
High RiskFDA
Smith & Nephew, Inc.
Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy External Power Supply Unit, Rx only. Intended for patients who would benef...
Medical Devices·15,960 affected·Nov 11, 2016
High RiskFDA
Greatbatch Medical
ViaPeel PTFE Peelable Introducer 5FR, Part Number 10890-006
Medical Devices·5,000 affected·Nov 11, 2016
High RiskFDA
Northern Fish Products, Inc.
PREMIUM SMOKED SALMON UPC 7 02772 00564 0 Packaged in a 5 lb case 20/4oz vacuum packaged per case. Cardboard type label is folded ove...
Seafood·28,487 affected·Nov 10, 2016
High RiskFDA
Northern Fish Products, Inc.
"***PREMIUM SMOKED SALMON***CRACKED PEPPER*** NET WT: 4OZ***Packaged 5 lbs case 20/4oz vacuum packages/case. Cardboard type label is fold...
Seafood·28,487 affected·Nov 10, 2016
CriticalFDA
Agave Dream
Agave Dream Cappuccino 1 Pint UPC Code 8 9934900204 8
Food·8,094 affected·Nov 10, 2016
CriticalFDA
Agave Dream
Agave Dream Chocolate Chip 1 Pint UPC Code 8 9934900302 1
Snacks & Candy·8,094 affected·Nov 10, 2016
High RiskFDA
Northern Fish Products, Inc.
WILD CATCH PREMIUM SMOKED SALMON***NATURAL***NET WT: 4OZ*** UPC 7 02772 00559 6. Cardboard type label is folded over and affixed to the...
Seafood·28,487 affected·Nov 10, 2016
CriticalFDA
American Blue Ribbon Holdings Dba Legendary Baking
Ultimate Chocolate Chip Cookie Dough Pie, refrigerated/frozen. A 9-inch pastry shell with a layer of chocolate chip cookie dough baked in...
Dairy·7,273 affected·Nov 10, 2016
High RiskFDA
Northern Fish Products, Inc.
Kippered Salmon Tips Product of USA Packed By Northern Fish Products***" Packaged in bulk 5lb case.
Seafood·28,487 affected·Nov 10, 2016
CriticalFDA
Agave Dream
Agave Dream Lavender 1 Pint UPC Code 8 9934900206 2
Food·8,094 affected·Nov 10, 2016
High RiskFDA
Northern Fish Products, Inc.
Sweet & Spicy Style Atlantic Salmon, Product of USA Packed By Northern Fish Products***" Packaged in bulk 5lb case.
Seafood·28,487 affected·Nov 10, 2016
CriticalFDA
Nutra Manufacturing
GNC, Womens Ultra Mega, Dietary Supplement, 180 Caplets,
Supplements·12,534 affected·Nov 10, 2016
High RiskFDA
Northern Fish Products, Inc.
Smoked Trout Rainbow Trout, NORTHERN FISH PRODUCTS, INC.***" Packaged in bulk 10lb case.
Seafood·28,487 affected·Nov 10, 2016
CriticalFDA
Agave Dream
Agave Dream Chocolate 1 Pint UPC Code 8 9934900202 4
Snacks & Candy·8,094 affected·Nov 10, 2016
High RiskFDA
Northern Fish Products, Inc.
PREMIUM SMOKED SALMON***CAJUN***NET WT: 4OZ***Cardboard type label is folded over and affixed to the top of the package. Sell by date i...
Seafood·28,487 affected·Nov 10, 2016