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
Montana Compounding Pharmacy
Trimix (A;PH,PA) (N), injectable, 160 UG-1.2 mg-9.6/ mg/mL, 2 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT.
Injectable Drugs·32 affected·May 15, 2015
High RiskFDA
Mallinckrodt, Inc.
MD-Gastroview (Diatrizoate Meglumine and Diatrizoate Sodium Solution USP); 37% Organically Bound Iodine For Gastrointestinal Radiography;...
Oral Drugs·6,600 affected·May 15, 2015
High RiskFDA
Montana Compounding Pharmacy
Trimix (A;PH,PA) (N), injectable, 80 UG-0.6 mg-4.8 mg/mL, 1 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT
Injectable Drugs·1 affected·May 15, 2015
High RiskFDA
Montana Compounding Pharmacy
Glutathione INHALATION (PF), NASAL solution, 100 mg/mL, 3 mL vial, Rx only, dispensed by Montana Compounding Pharmacy, Missoula, MT
Inhaled / Nasal Drugs·10 affected·May 15, 2015
High RiskFDA
Montana Compounding Pharmacy
Avastin, solution, 1.25 mg/0.05mL, Injectable, Syringe, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT
Injectable Drugs·259 affected·May 15, 2015
High RiskFDA
Montana Compounding Pharmacy
Trimix (PGE1;PHENT;PAP) (N), injectable, (100/10/297) 10UG, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT
Injectable Drugs·2 affected·May 15, 2015
High RiskFDA
Montana Compounding Pharmacy
Alprostadil (PFE1), solution, 20 mcg/mL, injectable, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT
Injectable Drugs·1 affected·May 15, 2015
High RiskFDA
Arthrocare Medical Corporation
EVAC 70 XTRA with Integrated Cable REF EICA5872-01 Product Usage: PLASMA WAND devices are indicated for ablation, resection, and coag...
Medical Devices·4,111 affected·May 15, 2015
High RiskFDA
Veridex, Llc
Cell Search Circulating Tumor Kit. Intended for the enumeration of circulating tumor cells (CTC) of epithelial origin in whole blood.
Medical Devices·1,560 affected·May 15, 2015
CriticalFDA
Aurora Products, Inc.
Raw Macadamia Nuts, packaged in 8 oz. plastic cup, packaged under the Aurora and private labels as follows:Belmont Market, Citarella, Ern...
Food·3,324 affected·May 14, 2015
High RiskFDA
Cook Inc.
LapSac Surgical Tissue Pouch. The current intended use for the LapSac Surgical Tissue Pouch is for isolating tissue during, or prior ...
Surgical Devices·123,184 affected·May 14, 2015
CriticalFDA
Teleflex Medical
Lifesaver Single Patient Use Manual Resuscitator Product Usage: The Hudson RCI Lifesaver Single Patient Use manual resuscitator with...
Respiratory Devices·9,333 affected·May 14, 2015
High RiskFDA
Mondelez International
Outer carton : Nabisco Newtons Fig 24-2 OZ (56 g) Packs Net Wt 3 lbs Mondelez International Mondelez Global LLC East Hanover, NJ 0793...
Food·69 affected·May 13, 2015
RecallFDA
West-ward Pharmaceutical Corp.
Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL), Rx Only, For IV or IM Use Preservative Free, 25 X 5 mL Single Dos...
Injectable Drugs·14,649 affected·May 13, 2015
High RiskFDA
Synthes, Inc.
3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the Cannulated Screws are indicated for fixation of fractures, os...
Medical Devices·54 affected·May 13, 2015
High RiskFDA
The Binding Site Group, Ltd.
Optilite Analyser, Product Code: IE700 Product Usage: The Thermo Scientific Indiko Clinical Chemistry Analyzer is a fully automated r...
Diabetes Devices·129 affected·May 13, 2015
CriticalFDA
Ethicon Endo-surgery Inc
SEDASYS Computer-Assisted Personalized Sedation System, SEDPRU01. An integrated physiological monitoring and drug delivery system int...
Medical Devices·14 affected·May 13, 2015
High RiskFDA
Synthes, Inc.
3.2 mm Cannulated Drill Bit/ QC 170 mm 2.7 Cannulated Drill Bit/ QC 160 mm 2.0 mm Cannulated Drill Bit / QC 150 mm there is no indica...
Medical Devices·1,495 affected·May 13, 2015
High RiskFDA
Carefusion 303, Inc.
Alaris PC unit model 8015, Infusion pump. software version 9.17 Product Usage: The Alaris PC unit is the central programming, monitori...
Medical Devices·63 affected·May 13, 2015
RecallFDA
Bio-rad Laboratories, Inc.
The spare component Anti-HBs Cutoff Calibrator, 10 mLU/mL, Catalog number 26154. The spare component is sold separately from the MONOL...
Medical Devices·20 affected·May 13, 2015
High RiskFDA
Advanced Back Technologies, Inc.
Extentrac Elite User Manual DCN: 14-001 (Powered decompression table, for traction)
Medical Devices·18 affected·May 13, 2015
High RiskFDA
Advanced Back Technologies, Inc.
Extentrac Elite product brochure DCN: 13-001, 09-001 (Powered decompression table, for traction)
Medical Devices·36 affected·May 13, 2015
CriticalFDA
Crystal Fresh
SNOBIZ CHEESECAKE SHAVE ICE FLAVOR, 10 pouches/carton; 8 cartons/case (80 pouches total per case), 104 gram per pouch, metallized pouch.
Dairy·19 affected·May 12, 2015
High RiskFDA
Allegiant Health
Famotidine Tablets, USP, 20 mg Tablets, Over the Counter, Made in India and labeled: a) freds Acid Controller, 25 Tablet Cartons, DISTRIB...
Oral Drugs·86,106 affected·May 12, 2015
High RiskFDA
Stryker Howmedica Osteonics Corp.
ReUnion TSA Shoulder System, Standard SR Humeral Head Trial, 48X18, Catalog number 5901-S-4818. Orthopedic manual surgical instrument. ...
Surgical Devices·21 affected·May 12, 2015
High RiskFDA
Vidacare Corporation
T.A.L.O.N (Tactically Advanced Lifesaving Intraosseous Needle) 15G x 38.5 mm 10 NEEDLE SET STERILE EO Single Use Rx only Vidacare Corpora...
Medical Devices·2,104 affected·May 12, 2015
High RiskFDA
Fine Land Corp
Fruit Juice Candy Bonbons de Jus de Fruits, Net Wt 8 oz (227g), UPC Code 6 923648 832113, Manufacturer. Jin Shun FA Food Co., Ltd. 147 co...
Snacks & Candy·27 affected·May 11, 2015
CriticalFDA
Deskins Wholesale, Llc
Deskins Candies, Chocolate No Bakes, Net Wt. 16-oz., packaged in 1 lb. plastic containers containing 8-10 cookies / 12 containers per cas...
Bakery & Grains·140 affected·May 11, 2015
High RiskFDA
Teva Pharmaceuticals Usa
Zebeta¿ (bisoprolol fumarate), tablets, 10mg, 30-count bottle, Rx only, Manufactured for Teva Pharmaceuticals Inc. 425 Privet Road, Horsh...
Oral Drugs·889 affected·May 11, 2015
High RiskFDA
Advanced Sterilization Products
EVOTECH Endoscope Cleaner and Reprocessing System 220-230V, P/N 50004-002. The ASP EVOTECH ECR Endoscope Cleaner and Reprocessor is a ...
Medical Devices·44 affected·May 11, 2015
High RiskFDA
Natural Creations Inc
250cc White Plastic Container containing 120 capsules, labeled Natural Creations New Zealand Colostrum, Colostrum Supplement, MFG. FOR: N...
Supplements·399 affected·May 8, 2015
CriticalFDA
Good Seed, Inc.
1-lb, 2-lb and 10-lb bags of Mung Bean Sprouts in clear plastic bags labeled GOODSEED Mung Bean Sprouts Keep Refrigerated
Food·0 affected·May 8, 2015
High RiskFDA
World Of Coca-cola
DASANI Purified Water, 24/20 fl. oz. (1.25 pt) 591 mL, pack, Desani, The Coca Cola Company, Atlanta, GA 30313.
Beverages·328,337 affected·May 8, 2015
CriticalFDA
Good Seed, Inc.
1-lb, 2-lb and 10-lb bags of Soybean Sprouts in clear plastic bags labeled GOODSEED Soy Bean Sprouts Keep Refrigerated
Food·0 affected·May 8, 2015
High RiskFDA
Bruce Foods Corporation
Del Pasado Dice Green Chiles 100% Fire Roasted and Peeled NET WT. 6 LB 3 OZ (2.81 kg) packaged in #10 steel cans
Food·816 affected·May 8, 2015
High RiskFDA
Ethicon, Inc.
Ethicon Fast Absorbing Plain Gut - MultiPass Needles, Sterile, Absorbable Surgical Suture, 5-0 (1.5 metric), 18" (45 cm), Conventional Cu...
Surgical Devices·1,922 affected·May 8, 2015
High RiskFDA
Gyrus Acmi, Incorporated
Gyrus ACMI Diego Elite Tubeset, intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and hard tissue in ...
Medical Devices·22,250 affected·May 8, 2015
High RiskFDA
Gyrus Acmi, Incorporated
Gyrus ACMI Diego Elite Tubeset; intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and hard tissue in ...
Medical Devices·12,020 affected·May 8, 2015
High RiskFDA
Toshiba American Medical Systems Inc
Toshiba Aquilion CT System TSX-301C
Medical Devices·459 affected·May 8, 2015
High RiskFDA
Toshiba American Medical Systems Inc
Toshiba Aquilion CT System TSX-303A
Medical Devices·459 affected·May 8, 2015
High RiskFDA
Toshiba American Medical Systems Inc
Toshiba Aquilion CT System TSX-301A
Medical Devices·459 affected·May 8, 2015
Medium RiskFDA
Teva Pharmaceuticals Usa
QVAR (beclomethasone dipropionate HFA 40 mcg), 40 mcg Inhalation Aerosol, For Oral Inhalation with QVAR Actuator Only, 120 metered inhal...
Oral Drugs·233,364 affected·May 7, 2015
High RiskFDA
Viewray Incorporated
Treatment Planning and Delivery System Software version 3.6. ViewRay. Indicated for stereotactic radiosurgery and precision radiother...
Medical Devices·3 affected·May 7, 2015
High RiskFDA
Roche Diagnostics Operations, Inc.
HDL-Cholesterol gen.3. For the quantitative determination of high-density lipoprotein Cholesterol (HDL-C) in serum and plasma.
Medical Devices·6,255 affected·May 7, 2015
High RiskFDA
Roche Diagnostics Operations, Inc.
Creatinine Plus ver. 2. Intended for use on COBAS INTEGRA systems , cobas c111, and cobas c systems for the quantitative determination...
Medical Devices·6,255 affected·May 7, 2015
High RiskFDA
Atrium Medical Corporation
Ocean Water Seal Chest Drain, Single Collection W/AC, P/N: 2002-000
Medical Devices·390 affected·May 7, 2015
High RiskFDA
Roche Diagnostics Operations, Inc.
HDL-Cholesterol plus gen.3.; and Small Supersized Intended for use on COBAS Integra 800 and 400 plus systems, cobas c111, and cobas c ...
Medical Devices·6,255 affected·May 7, 2015
High RiskFDA
Roche Diagnostics Operations, Inc.
Uric Acid plus ver.2 In vitro test for the quantitative determination of uric acid in human serum, plasma and urine or Roche/Hitachi M...
Medical Devices·6,255 affected·May 7, 2015