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
www.fda.gov →Official Site

Have an unsafe medication, device, or food to report?

Filing a report with the FDA is free and takes a few minutes. Consumer reports drive future recalls and help the agency identify safety patterns.

How to report to FDA →
68,659 recalls
High RiskFDA
Aso, Llc
Walgreens ("W" and "Well at Walgreens") Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC...
Surgical Devices·2,689,560 affected·Jul 26, 2013
High RiskFDA
Carestream Health, Inc.
DRX Revolution Mobile X-Ray System, Model DRXR-1, Verona Street Rochester, NY 14608 Catalog Numbers 1019397, 1023415, 1023423 --- Made...
Medical Devices·23 affected·Jul 26, 2013
High RiskFDA
Aso, Llc
TopCare Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 036800165854 Used to secur...
Surgical Devices·2,689,560 affected·Jul 26, 2013
High RiskFDA
Atlas Spine, Inc.
Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used to rotate implant into position
Medical Implants·16 affected·Jul 26, 2013
High RiskFDA
Aso, Llc
Meijer Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 719283595973 Used to secur...
Surgical Devices·2,689,560 affected·Jul 26, 2013
High RiskFDA
Aso, Llc
Duane Reade (DR) Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 639194043885 Used...
Surgical Devices·2,689,560 affected·Jul 26, 2013
High RiskFDA
Terumo Cardiovascular Systems Corporation
220/240V AC, Advanced Perfusion System 1 Product Usage: The Terumo¿ Advanced Perfusion System 1 is indicated for use in extracorporea...
Medical Devices·1,657 affected·Jul 26, 2013
CriticalFDA
Gold Star Smoked Fish Corp.
RYBACKA WIES brand HERRING FILLETS IN OIL (MATJES SLEDZ W OLEJU), Net Wt. 17.6 oz. (500g), UPC 0 21143 24122 8, Distributed By Gold Star,...
Food·30 affected·Jul 25, 2013
High RiskFDA
Tortilleria Lupita, Inc.
Tortillas Lupita Flour Tortillas, Net Wt. 23oz, Manufactured By Tortilleria Lupita, 235 SW 25th St., Oklahoma City, OK 73109
Food·154 affected·Jul 25, 2013
Medium RiskFDA
Thrive Foods Llc
THRIVE 6 Grain Pancake Mix; There are two unit sizes: (1) 4 lb. #10/gallon can (6.03x 7.02) (the "Gallon Cans"); and (2) 1.17 lb. Pul...
Bakery & Grains·100,116 affected·Jul 25, 2013
RecallFDA
Hi-tech Pharmacal Co., Inc.
Clobetasol Propionate Cream, USP, 0.05%, 15 grams, Rx only, Hi-Tech PHARMACAL label, Hi-Tech Pharmacal, Co., Inc., Amityville, NY 11701, ...
Topical Drugs·58,812 affected·Jul 25, 2013
High RiskFDA
Medtronic Navigation, Inc.
Medtronic O-arm Imaging System Mobile X-ray system. Model No. BI-700-00027 and BI-700-00028 The 0-arm Imaging System is a mobile x-ra...
Medical Devices·449 affected·Jul 25, 2013
High RiskFDA
Advanced Sterilization Products
STERRAD 100NX Cassettes, Product Code: 10144 The STERRAD Sterilization System is a low temperature general purpose sterilizer used to ...
Medical Devices·1,923 affected·Jul 25, 2013
High RiskFDA
Velocity Medical Solutions, Llc
DICOM Export Format for Sum Dose with Velocity v3.0.0. A stand-alone software product that provides the oncology care specialists (phy...
Diagnostic Devices·54 affected·Jul 25, 2013
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Folate (2500 tests), REF SMN 10340209, Cat No. 09132781 In vitro diagnostic use in the quantitative determination of fol...
Diagnostic Devices·44 affected·Jul 25, 2013
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Folate (500 Tests) SMN 10325366, Cat No. 06891541 In vitro diagnostic use in the quantitative determination of folate in...
Diagnostic Devices·2,840 affected·Jul 25, 2013
High RiskFDA
Hemocue Ab
HemoCue¿ Hb 201 Microcuvettes, carton/4 boxes/25 pouches of Microcuvettes, HemoCue AB Angelholm, Sweden
Medical Devices·42,330 affected·Jul 25, 2013
High RiskFDA
Tortilleria Lupita, Inc.
Tortillas Lupita White Corn Tortillas, Manufactured by Tortilleria Lupita, 235 SW 25th St, Oklahoma City, OK 73109
Food·6 affected·Jul 24, 2013
High RiskFDA
Johnson Brothers Liquor Company, Inc
Evviva Fresh Peach Spumante, UPC 84279-99137
Food·1,750 affected·Jul 24, 2013
High RiskFDA
Giant Eagle
Giant Eagle Candy Place Chocolate Covered Peanuts NET WT. 5 OZ, UPC code 3003404313 This product was packaged in a facility that also...
Dairy·0 affected·Jul 24, 2013
High RiskFDA
Johnson Brothers Liquor Company, Inc
Evviva Strawberry Spumante, UPC 84279-99138
Produce·1,750 affected·Jul 24, 2013
High RiskFDA
Baxter Healthcare Corp.
DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL container, Rx only, Baxter Healthcare Corporatio...
Drugs·39,486 affected·Jul 24, 2013
High RiskFDA
Nestle Healthcare Nutrition
Nestle Nutrition, Compat, Enteral Feeding Tube, sterile, 8 French (REF 08310400), 10 French (REF 08310600), and 12 French (REF 08310500)....
Medical Devices·37,310 affected·Jul 24, 2013
High RiskFDA
Orthopediatrics Corp
3.2mm Drill Bit. This is a component within the PediLoc Locking Plate System utilized to pre-drill a hole in bone prior to placement of a...
Medical Devices·68 affected·Jul 24, 2013
High RiskFDA
Gyrus Medical, Inc
GYRUS ACMI, REF 3740, Everest BiCOAG Bipolar Dissecting Forceps 5mm/45 cm, Sterile EO. GYRUS ACMI, REF 3740PK, or REF 94201PK, PKS LYO...
Surgical Devices·1,140 affected·Jul 24, 2013
High RiskFDA
Mira Health Products Ltd.
Bolt: Fat Incenerator capsules packaged within a container (60 capsules per bottle).
Food·0 affected·Jul 23, 2013
High RiskFDA
Teva Pharmaceuticals Usa, Inc.
Terazosin Hydrochloride Capsules,10 mg, 100-count bottle, Rx only, Manufactured for Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC...
Oral Drugs·6,267 affected·Jul 23, 2013
High RiskFDA
Elekta, Inc.
Stereotactic Circular Collimator - 3D Line stereotatic Hardware Accessories The device is part of the class of medical devices that ar...
Medical Devices·89 affected·Jul 23, 2013
High RiskFDA
New Sun Inc
New Sun Immune 101, Dietary Supplement 360 Capsule bottles and 100 capsule bottles, New Sun, Inc, Hendersonville NC 28792 1-800-544-0777 ...
Supplements·61,840 affected·Jul 22, 2013
High RiskFDA
New Sun Inc
New Sun JLB Combination, Dietary Supplement, 100 capsule bottle, New Sun, Inc., Hendersonville, NC 1-800-544-0777 www.newsun.net Product ...
Supplements·38,900 affected·Jul 22, 2013
CriticalFDA
Mira Health Products Ltd.
Super-DMZ Rx 2.0 Capsules, 60 count bottles, Dietary Supplement, Lean muscle mass, hardness and strength, Manufactured for Blackstone Lab...
Oral Drugs·11,200 affected·Jul 22, 2013
CriticalFDA
Mira Health Products Ltd.
B-50 capsules, Healthy Life Chemistry By Purity First, packaged in 100 count bottles, Manufactured for: Purity First Health Products, Inc...
Oral Drugs·0 affected·Jul 22, 2013
High RiskFDA
Torrent Pharma Inc
Olanzapine Tablets, USP, 10 mg, Rx Only, 30 tablets per bottle, Mfd for: Prasco Laboratories, Mason OH, 45040, USA, Mfd by: Torrent Pharm...
Oral Drugs·18,721 affected·Jul 22, 2013
CriticalFDA
Mira Health Products Ltd.
METHA-DROL Extreme capsules, packaged as 60 capsules per bottle Pro-Anabolic Mass Stack Dietary Supplement, Manufactured for Blackstone L...
Oral Drugs·5,555 affected·Jul 22, 2013
High RiskFDA
Mckesson Technologies Inc
Mc Kesson Anesthesia-Rx Model Number 8.0.2 & 8.0.1 with RapiDispense Product Usage: Automated anesthesia cart that monitors and cont...
Surgical Devices·106 affected·Jul 22, 2013
High RiskFDA
Biomet 3i, Llc
Tapered Navigator Certain Surgical Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave pr...
Surgical Devices·170 affected·Jul 22, 2013
High RiskFDA
Philips Medical Systems (cleveland) Inc
MX 16-Slice CT Scanner System. Used as a whole-body computed tomography X-Ray system.
Medical Devices·326 affected·Jul 22, 2013
High RiskFDA
Biomet 3i, Llc
Navigator Surgical Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.
Surgical Devices·21 affected·Jul 22, 2013
High RiskFDA
Sensoryeffects Powder Systems
Maple flavored lipid-based inclusions. Maple NT-RF and Maple NT-MF, NET WT: 50 lbs, Ingredients: Sugar, vegetable oil (palm, palm kernel...
Produce·2,013 affected·Jul 20, 2013
High RiskFDA
Plum Inc
Plum Organics Mighty 4 Essential nutrition blend; Pumpkin Pomegranate Quinoa, Greek yogurt in 4 oz pouch. Six pouches per box. USDA Org...
Dairy·81,347 affected·Jul 19, 2013
High RiskFDA
Plum Inc
Plum Organics Mighty 4 Essential nutrition blend; Purple Carrot Berry Quinoa, Greek yogurt in 4 oz pouch. Six pouches per box. USDA Org...
Dairy·81,347 affected·Jul 19, 2013
High RiskFDA
Plum Inc
Plum Organics Mighty 4 Essential nutrition blend; Sweet Potato Blueberry Millet , Greek yogurt in 4 oz pouch. Six pouches per box. USDA...
Dairy·81,347 affected·Jul 19, 2013
CriticalFDA
Zip International Group Llc.
FOSFOREL brand Herring Fillet in Oil 400 gram (14 oz.) in plastic packaging containers; refrigerated
Food·48 affected·Jul 19, 2013
High RiskFDA
Csm Bakery Products North America
10-inch Supreme Chocolate Layered Cake; 12 units per shipping case
Bakery & Grains·6,400 affected·Jul 19, 2013
High RiskFDA
Plum Inc
Plum Organics Mighty 4 Essential nutrition blend; Kale, Strawberry, Amaranth, Greek yogurt in 4 oz pouch. Six pouches per box. USDA Org...
Dairy·81,347 affected·Jul 19, 2013
RecallFDA
Watson Laboratories Inc
Oxycodone and Acetaminophen Capsules, USP 5mg/500 mg, packaged in a)100-count bottle (NDC 0591-0737-01), b) 500-count bottle (NDC 0591-07...
Oral Drugs·1,260 affected·Jul 19, 2013
CriticalFDA
Herbal Give Care Llc
Esbelder Siloutte Suplemento Alimenticio, 30 capsule bottle, Hecho en Mexico Por: Herbal Give Care, Av Independencia # 1016, Fracc. La R...
Oral Drugs·54 affected·Jul 19, 2013
CriticalFDA
Myson Corporation, Inc.
Volcano Male Enhancement 1500mg, 1-count capsule packaged in a black round plastic pop top container, (Proprietary Formula, Pueraria loba...
Oral Drugs·0 affected·Jul 19, 2013