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
X-gen Pharmaceuticals Inc.
Nystatin Topical Powder, USP, 100,000 USP units per gram, 15 grams per bottle, Rx only, Vensun, NDC 42543-052-61
Topical Drugs·9,816 affected·May 17, 2017
High RiskFDA
Vistapharm, Inc.
Nystatin Oral Suspension, USP, 100,000 units/mL, packaged in a) 2 fl.oz. (60mL) bottles (NDC 66689-008-02), and 500,000 units/5mL individ...
Oral Drugs·2,208,500 affected·May 17, 2017
High RiskFDA
Medtronic Sofamor Danek Usa Inc
KYPHON(R) Directional Bone Filler Device, Size: 3, REF F04C, Rx Only, STERILE R.
Medical Devices·17,657 affected·May 17, 2017
High RiskFDA
Z-medica, Llc
QuikClot TraumaPad, , sterile, soft, white, X-ray detectable hemostatic dressing Part Number 460 Manufactured by Z-Medica, LLC 4 Fair...
Surgical Devices·2,910 affected·May 17, 2017
High RiskFDA
Biosense Webster, Inc.
PENTARAY NAV High-Density Mapping Catheter.
Surgical Devices·73,796 affected·May 17, 2017
High RiskFDA
Prosupps Usa Llc
Mr. Hyde Blue Razz (V2)
Food·34,124 affected·May 16, 2017
High RiskFDA
Prosupps Usa Llc
Mr. Hyde Watermelon (V2); Mr. Hyde 30 Watermelon
Beverages·22,561 affected·May 16, 2017
High RiskFDA
Prosupps Usa Llc
Dr. Jekyll V2 Orange Burst domestic
Food·698 affected·May 16, 2017
High RiskFDA
Prosupps Usa Llc
Dr. Jekyll V2 Watermelon domestic
Beverages·6,348 affected·May 16, 2017
High RiskFDA
Prosupps Usa Llc
Mr. Hyde, Fruit Punch, 30 servings; Mr. Hyde Fruit Punch (V2); Mr. Hyde 30 INT'L Fruit Punch; Mr. Hyde Fruit Punch RTD; Mr. Hyde V2 domes...
Produce·37,983 affected·May 16, 2017
High RiskFDA
Prosupps Usa Llc
Dr. Jekyll 30 Fruit Punch
Produce·3,957 affected·May 16, 2017
High RiskFDA
Prosupps Usa Llc
Dr. Jekyll V2 Green Apple International
Food·3,045 affected·May 16, 2017
High RiskFDA
Prosupps Usa Llc
Mr. Hyde Green Apple; Mr. Hyde Green Apple Sweden
Food·28,045 affected·May 16, 2017
CriticalFDA
Lupin Limited (unit 1)
Mibelas 24 Fe (Norethindrone acetate and Ethinyl estradiol 1 mg/0.02 mg chewable and ferrous Fumarate 75 mg) Tablets, wallet of 28 tablet...
Oral Drugs·24,652 affected·May 16, 2017
High RiskFDA
Glaxosmithkline, Llc
Ventolin HFA (albuterol sulfate) Inhalation, 90 mcg per actuation, 200 Metered Inhalations, Net Wt. 18 g inhalers, Rx only, GlaxoSmithKli...
Inhaled / Nasal Drugs·562,883 affected·May 16, 2017
High RiskFDA
Exactech, Inc.
Vantage Total Ankle Tibial Insert, Fixed Bearing, 10 mm, Left, Size 3. Exactech Inc. Intended for patients with ankle joints damage by...
Medical Devices·9 affected·May 16, 2017
High RiskFDA
Biomerieux Inc
VITEK 2 Gram Negative test kits containing colistin (cs01n)
Diagnostic Devices·1,520,000 affected·May 16, 2017
High RiskFDA
Exactech, Inc.
Vantage Total Ankle Tibial Insert, Fixed Bearing, 7 mm, Left, Size 3. Exactech Inc., Intended for patients with ankle joints damage...
Medical Devices·9 affected·May 16, 2017
CriticalFDA
Wang Globalnet
Fish Tofu in Polybag 40/240g, Item no. 17185, UPC Code 087703171855
Seafood·3 affected·May 15, 2017
CriticalFDA
Wang Globalnet
Fish Cake in Polybag 10/2.2lbs, Item no. 12842 UPC Code 087703128422
Seafood·189 affected·May 15, 2017
CriticalFDA
Wang Globalnet
Fish Cake in Polybag 10/930g, Item no. 15731 UPC Code 087703157316
Seafood·4 affected·May 15, 2017
CriticalFDA
Wang Globalnet
Fish Cake in Polybag 20/1lb., Item no. 13125 UPC Code 087703131256
Seafood·5 affected·May 15, 2017
CriticalFDA
Wang Globalnet
Fish Ball in Polybag 24/12oz., Item no. 20072, UPC Code 087703200722
Seafood·2 affected·May 15, 2017
High RiskFDA
Baxter Healthcare Corporation
Milrinone Lactate in 5% Dextrose Injection, 20 mg/100 mL, 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporati...
Injectable Drugs·90,450 affected·May 15, 2017
High RiskFDA
Baxter Healthcare Corporation
Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, De...
Injectable Drugs·113,590 affected·May 15, 2017
High RiskFDA
Perkinelmer Life Sciences, Inc.
Multiphor II Electrophoresis System GE HealthCare Product Number: 18-1018-06 PerkinElmer Part Number: 2117-004 Product Usage: Mu...
Medical Devices·241 affected·May 15, 2017
High RiskFDA
Beckman Coulter Inc
Beckman Coulter Synchron AQUA CAL Level 1, Part No. 471288 Product Usage: Used for the system calibration of Na, K, Cl, Urea N, Urea,...
Diabetes Devices·4,444 affected·May 15, 2017
High RiskFDA
Biomerieux, Inc.
VIDAS Testosterone, Ref 30418
Medical Devices·742 affected·May 15, 2017
High RiskFDA
Boston Scientific Corporation
FFR Link-FFR Signal Processing Module, Material Number H7495551000 It is intended to condition physiological signals from measuring devi...
Medical Devices·3 affected·May 15, 2017
High RiskFDA
Sabor Mexicano
Sabor Mexicano Homemade Corn Chips: Packaged in 12 oz. (9 units per case), UPC 8-53094-00417-7, and Fun size 5 oz. ( 12 units per cas...
Snacks & Candy·4,959 affected·May 14, 2017
CriticalFDA
Wholefoods Market
Oatmeal Chocolate Chip Cookies, 18pk, NET WT. 0 lb 10 oz (283 g), Dist. by Whole Foods Market, 1105 N. Lamar, Austin, TX 78703 USPC 0247...
Bakery & Grains·12 affected·May 13, 2017
CriticalFDA
Green Chile Foods, Inc.
Bean & Cheddar with Salsa, FIRE ROASTED Corn & Red Bell Pepper Burrito. MILD, Net WT 7oz, Item # 886, Case UPC 833425001464, Item UPC 8 ...
Frozen Food·785 affected·May 13, 2017
CriticalFDA
Green Chile Foods, Inc.
Bean & Cheese Burrito with Monterey Jack, Salsa, Green Chile, Rice, & Serrano Peppers!, Item # 484, Case UPC 8 33425 00086 3, Item UPC 8 ...
Dairy·5,168 affected·May 13, 2017
CriticalFDA
Isf "usa", Llc
Viking, Breaded Natural Flounder Fillets 4 oz.
Bakery & Grains·263 affected·May 12, 2017
CriticalFDA
Isf "usa", Llc
High Liner Foods, Lightly Breaded Cod Tail Portions 4 oz. and 5 oz
Bakery & Grains·2,244 affected·May 12, 2017
CriticalFDA
Isf "usa", Llc
High Liner Foods, Breaded Haddock Tail Portions 5 oz.
Bakery & Grains·897 affected·May 12, 2017
CriticalFDA
Isf "usa", Llc
A&W, GIN 0040995 Raw Breaded Fish Portions 3.5 oz
Seafood·374 affected·May 12, 2017
CriticalFDA
Isf "usa", Llc
FPI, Crunchy Lites Raw Breaded Alaska Pollock Portions 3.6 oz
Bakery & Grains·1,581 affected·May 12, 2017
High RiskFDA
New Punjab Sweets Inc.
New Punjab Sweets, Jalebi
Food·36 affected·May 12, 2017
High RiskFDA
Depuy Mitek, Inc., A Johnson & Johnson Co.
DePuy Mitek LATARJET EXPERIENCE Extraction Driver Product Code: 288216 Product Usage: The Latarjet Cortical Screw set is intended to ...
Medical Devices·115 affected·May 12, 2017
High RiskFDA
Depuy Mitek, Inc., A Johnson & Johnson Co.
DePuy Mitek LATARJET EXPERIENCE Coracoid Drill Product Code: 288201 Product Usage: The Latarjet Cortical Screw set is intended to trea...
Medical Devices·184 affected·May 12, 2017
High RiskFDA
Depuy Mitek, Inc., A Johnson & Johnson Co.
DePuy Mitek LATARJET EXPERIENCE Top Hat Tap Product Code: 288203 Product Usage: The Latarjet Cortical Screw set is intended to treat ...
Medical Devices·153 affected·May 12, 2017
High RiskFDA
Terumo Cardiovascular Systems Corp
Tubing Pack Convenience Kit, Product Code 65217 Product Usage: Intended for use only in the extracorporeal circuit of the cardiopulmo...
Medical Devices·30 affected·May 12, 2017
High RiskFDA
Trident Seafoods Corp - Island Enterprise M/v
Trident Item # 38520, Panko Breaded Alaska Cod, 4 oz. Square Portions Raw, Food Service packages, frozen, Net Wt. 10 lbs.
Bakery & Grains·432 affected·May 11, 2017
High RiskFDA
Trident Seafoods Corp - Island Enterprise M/v
Trident Item # 16596, Alaska Cod Diamond Cut 3 oz, English Style Battered Deep Fry, food service packages, frozen, Net wt. 10 lbs.
Frozen Food·707 affected·May 11, 2017
High RiskFDA
Trident Seafoods Corp - Island Enterprise M/v
Trident Item # 474568, Irregulars Battered Cod 3 oz Battered Diamonds, food service packages, frozen, Net wt. 10 lbs.
Frozen Food·10 affected·May 11, 2017
High RiskFDA
Lyrical Foods Inc
Kite Hill Mushroom and Ricotta Ravioli; frozen Ravioli made with almond milk ricotta: 9 oz. package. UPC 856624004173 Owned and d...
Dairy·1,000 affected·May 11, 2017
High RiskFDA
Trident Seafoods Corp - Island Enterprise M/v
Trident Item # 17116, Alaska Cod Rectangles 3 oz,Crunchy Breaded, food service packages, frozen, Net wt. 10 lbs.
Bakery & Grains·294 affected·May 11, 2017