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
Ge Healthcare, Llc
GE Healthcare Discovery MR450, Discovery MR750, Optima MR450w, Optima MR450w equipped with the GEM option, Discovery MR750w, and Discover...
Diagnostic Devices·1,548 affected·Apr 23, 2014
High RiskFDA
Elekta, Inc.
Synergy XVI Intended for radiation therapy treatment.
Medical Devices·380 affected·Apr 23, 2014
CriticalFDA
Ub Inc Dba United Bakery & Co
United Bakery Grissini Parmesan Bread Sticks,; Made with Extra Virgin Olive Oil and Grano Padano Cheese; All Natural, Trans Fat Free; ...
Dairy·14 affected·Apr 22, 2014
CriticalFDA
Miravalle Foods, Inc
Miravalle (brand) Achiote Molido Ground Annato (spice), 0.75oz.
Food·14,299 affected·Apr 22, 2014
High RiskFDA
Sigmapharm Laboratories Llc
Liothyronine Sodium Tablets, USP 5 mcg, Rx Only, a) 100-count bottle NDC 42794-018-02 and b) 1000-count bottle NDC 42794-018-06, SigmaPha...
Oral Drugs·43,007 affected·Apr 22, 2014
High RiskFDA
Smiths Medical Asd, Inc.
SW-2008 Snuggle Warm Sterile Cardiac Connective Warming Blanket; used with the Equator Convective Warmer, are intended for thermal regul...
Cardiac Devices·2,120 affected·Apr 22, 2014
CriticalFDA
Hamilton Medical, Inc.
HAMILTON-G5 Ventilator with software versions between V2.00 and V2.31. Anesthesiology: The HAMILTON-G5 ventilator is designed for inten...
Respiratory Devices·1,128 affected·Apr 22, 2014
High RiskFDA
Beckman Coulter Inc.
UniCel DxC Synchron Clinical Systems and UniCel DxC Synchron Access Integrated Clinical Systems The affected part is Part number 70300...
Medical Devices·3,540 affected·Apr 22, 2014
High RiskFDA
Meridian Bioscience Inc
illumipro-10 Incubator/Reader, Meridian Bioscience, Inc. The illumipro-10 incubator/reader is designed to be used with illumigene Mole...
Diagnostic Devices·35 affected·Apr 22, 2014
High RiskFDA
Wegmans Food Markets, Inc.
Scale label printed with "EASTER BREAD NET WT 17oz (1.06lb)" UPC 0 77890 32431 8, packaged in clear plastic bag
Bakery & Grains·29,681 affected·Apr 21, 2014
CriticalFDA
Hospira Inc.
Marcaine (bupivacaine HCl) injection, USP, 0.25%, Preservative-Free, 10 mL (25 mg) Single-dose Vial, Rx only, Hospira, Inc., Lake Forest,...
Injectable Drugs·85,680 affected·Apr 21, 2014
High RiskFDA
Pharmakon Pharmaceuticals
Glycopyrrolate 0.2 mg/ml, 5 mL pre-filled syringe, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville, IN 46060, NDC...
Drugs·200 affected·Apr 21, 2014
CriticalFDA
Pharmakon Pharmaceuticals
Midazolam HCl 2 mg/ml in 0.9% Sodium Chloride in 30 mL PVC Vial, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville I...
Drugs·20 affected·Apr 21, 2014
CriticalFDA
Pharmakon Pharmaceuticals
Midazolam HCl 1 mg/ml in 0.9% Sodium Chloride in 50 mL and 100 mL IV bag, Rx Only. Labeled A) 50 mL, Pharmakon Pharmaceuticals, Inc., 14...
Injectable Drugs·10 affected·Apr 21, 2014
CriticalFDA
Pharmakon Pharmaceuticals
Atropine Sulfate 0.4 mg/ml Injection, USP, Total Dosage 0.8 mg per 2 mL, 3 mL pre-filled syringe, Rx Only. Pharmakon Pharmaceuticals, In...
Injectable Drugs·5 affected·Apr 21, 2014
High RiskFDA
Baxter Healthcare Corp.
0.9% Sodium Chloride Irrigation, USP, 1000 mL,Not for Injection, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, USA...
Injectable Drugs·211,752 affected·Apr 21, 2014
High RiskFDA
Aesculap, Inc.
Aesculap Inc.(AIC) Miethke Ventricular Catheter with Deflector/Miethke Shunt System The Miethke Shunt System is intended to shut cere...
Surgical Devices·48 affected·Apr 21, 2014
CriticalFDA
Whole Foods Market Brand 365, Llc
Mini Butter Croissant 6 Pack Ingredients: Wheat Flour (unbleached enriched wheat flour, malted barley flour, niacin, Iron, thiamin monon...
Dairy·251 affected·Apr 18, 2014
RecallFDA
French Broad Luscious Chocolates
French Broad Chocolates, Bubbie's Almond Bar, 60g (2.1 oz) bar, with aluminum foil with polyester ribbon & paper outer wrapper
Snacks & Candy·210 affected·Apr 18, 2014
CriticalFDA
Woeber Mustard Manufacturing Co Inc
Hickory Farms Chipotle Ranch Sauce; 9 oz. clear plastic pinch waist bottle
Snacks & Candy·281,796 affected·Apr 18, 2014
CriticalFDA
Hickory Farms Inc
Hickory Farms Farmstand Recipe Chipotle Ranch Sauce Net Weight 9 Ounces
Snacks & Candy·282,192 affected·Apr 18, 2014
CriticalFDA
Charles Products Inc
Shot glasses with decorative artwork that reads Blue: "Who's Your Candy?!" SKU # 835989 Green: "Eye Candy" SKU # 835990 Red: "Hard ...
Snacks & Candy·8,640 affected·Apr 18, 2014
CriticalFDA
Charles Products Inc
Pint sized glasses with decorative artwork that reads Blue: "Who's Your Candy?!" SKU # 835992 Green: "Eye Candy" SKU # 835993 Red: "...
Snacks & Candy·8,640 affected·Apr 18, 2014
RecallFDA
Apotex Corp.
Olanzapine Orally Disintegrating Tablets 5 mg, 30-count Bottle, Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada M9L1T9, Manu...
Oral Drugs·5,397 affected·Apr 18, 2014
CriticalFDA
Hospira Inc.
1% LIDOCAINE HCl Injection, USP, Preservative-Free, 10 mg/mL, 30 mL Single-dose vials, packaged in 25-count cartons, Rx only, Hospira, In...
Injectable Drugs·120,900 affected·Apr 18, 2014
High RiskFDA
Med-mizer, Inc.
RetractaBed , Clinical Contour, Med - Mizer Inc..... Model SS 762 ( 76 " bed w/ 2 motors); 763 (3 motors); 763 A ( 3 motors, autocontou...
Medical Devices·191 affected·Apr 18, 2014
High RiskFDA
Nellcor Puritan Bennett Inc. (dba Covidien Lp)
Recalled product is a component of the Newport Medical Instruments e360 Ventilator: single board computer, part number SBC2105A. Inte...
Respiratory Devices·5,765 affected·Apr 18, 2014
High RiskFDA
Leica Microsystems, Inc.
Thyroglobulin (1D4) is a mouse anti-human monoclonal antibody produced as a tissue culture supernatant, and supplied in Tris buffered sal...
Diagnostic Devices·180 affected·Apr 18, 2014
CriticalFDA
Cubist Pharmaceuticals, Inc.
CUBICIN (daptomycin for injection), 500 mg single-use vial, Rx only, Manufactured for: Cubist Pharmaceuticals, Inc., Lexington, MA 02421...
Injectable Drugs·51,500 affected·Apr 17, 2014
High RiskFDA
Wockhardt Usa Inc.
Wockhardt Metoprolol Succinate, Extended-Release Tablets USP, 50 mg, a)100-count HDPE bottle (NDC 64679-735-02), b) 4000-count pack (64...
Oral Drugs·1,118,400 affected·Apr 17, 2014
Medium RiskFDA
Trigen Laboratories, Inc.
Triveen - PRx RNF Capsules, 30-count bottles, Rx only; Manufactured for: Trigen Laboratories, Inc., Sayreville, NJ 08872, NDC 13811-558-...
Oral Drugs·142,732 affected·Apr 17, 2014
RecallFDA
Gen-probe Inc
APTIMA Urine Collection Kit; Catalog Number 301040, Lots 27231, 27232, 27233, and 27234. Product Usage: The APTIMA Urine Specimen Co...
Diagnostic Devices·4,740 affected·Apr 17, 2014
High RiskFDA
Teleflex Medical
Hudson RCI Adult Universal Ventilator Circuit, Duel Heated Limb and Hudson RCI Adult Heated Wire Circuit Kit with Column
Respiratory Devices·2,600 affected·Apr 17, 2014
High RiskFDA
Ortho-clinical Diagnostics
enGen (TM) Laboratory Automation System Configured with TCAutomation" Software v3.5 -- For in vitro quantitative measurement of a variety...
Diagnostic Devices·6 affected·Apr 17, 2014
High RiskFDA
Nanosphere, Inc.
Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the sample-to-result Verigene System, is a qualitative mu...
Diagnostic Devices·580 affected·Apr 17, 2014
High RiskFDA
Oaxaca Mexican Products
Botanos Los 3 Chavos Mango Enchilado Net Wt. 1 1/2 OZ. (42 g) Oaxaca Mexican Products 100 8th Street, Passaic, NJ 07055
Food·10 affected·Apr 16, 2014
High RiskFDA
Pfizer Us Pharmaceutical Group
Pristiq (desvenlafaxine) Extended-Release Tablets 50 mg, 30 count bottle, Rx only, Distributed by Wyeth Pharmaceuticals, Inc., NDC 0008-...
Oral Drugs·220,761 affected·Apr 16, 2014
High RiskFDA
Heartware Inc
HeartWare HVAD Pump Implant Kit (Heartware Ventricular Assist Device) - HeartWare Battery For use as a bridge-to-cardiac transplantati...
Medical Implants·32,349 affected·Apr 16, 2014
High RiskFDA
Stryker Endoscopy
12-Instrument Sterilization Tray; Product Usage: The 12-Instrument Tray is used to hold and protect surgical instruments during the s...
Surgical Devices·2,591 affected·Apr 16, 2014
High RiskFDA
Integra Lifesciences Corp.
Integra Licox Test Kit REF BC10R Rx Only An accessory provided for use with the LCXO2 and AC31 PtO2 Monitors. It provides users with ...
Diagnostic Devices·49 affected·Apr 16, 2014
High RiskFDA
Gambro Renal Products, Incorporated
Polyflux Revaclear Max, Capillary Dialyzer, Model Number 110634; Gambro Renal Products, Inc. Intended for the treatment of acute and...
Medical Devices·2,461,824 affected·Apr 16, 2014
High RiskFDA
P&l Developments, Llc
Children's Triacting Night Time Cold & Cough with PE (diphenhydramine hcl and phenylephrine hcl), Grape Flavor, For Ages 6 to 11, 4 fl o...
Drugs·1,363,338 affected·Apr 15, 2014
CriticalFDA
Sung Soo Kim
Super ARTHGOLD 500mg, 120 Capsule Bottle, Dietary Supplement. Manufactured for & Distributed by Nanowellbeing Health, Inc., 14747 Artesi...
Oral Drugs·6,336 affected·Apr 15, 2014
High RiskFDA
Biomet, Inc.
EZPass Nylon Monofilament Single Pack, Part number 110007379, Orthopedic Manual Surgical Instrument Sterile, single use arthroscopic inst...
Surgical Devices·100 affected·Apr 15, 2014
High RiskFDA
Handicare Usa, Inc.
ReTurn 7500/7500 Aid, transfer
Medical Devices·29 affected·Apr 15, 2014
High RiskFDA
Cordis Corporation
RenLane Renal Denervation Catheter; Cat No.: D135601. Used in adults patients (>18 years) with drug resistant hypertension to denervate ...
Surgical Devices·98 affected·Apr 15, 2014
High RiskFDA
Biomet, Inc.
EZPass Passer, Sterile single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid in passing suture through so...
Medical Devices·102 affected·Apr 15, 2014
CriticalFDA
Golub Corporation
Price Chopper brand Hummus TUSCAN WHITE BEAN, NET WT. 10 OZ. Labels applied to clear plastic container with black rim on lid.
Food·72 affected·Apr 14, 2014