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
Vistapharm, Inc.
Lactulose Solution, USP 20 g/30 mL, 50 unit dose cups of 30 mL per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66...
Drugs·18,437 affected·Jan 18, 2017
High RiskFDA
Vistapharm, Inc.
Nystatin Oral Suspension, USP 500,000 Units/5 mL, a). 50 unit dose cups of 5 mL per case (NDC No. 66689-037-50), b). 100 unit dose cups o...
Oral Drugs·55,191 affected·Jan 18, 2017
High RiskFDA
Vistapharm, Inc.
Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/325 mg per 15 mL C-II, a) 4 fl.oz .(120 mL), 12 bottles per case (NDC 666...
Oral Drugs·32,027 affected·Jan 18, 2017
High RiskFDA
Vistapharm, Inc.
Methadone Hydrochloride Oral Concentrate, USP 5 mg/5 mL C-II, 500 mL, 6 bottles per case, Rx only, Manufactured by VistaPharm, Largo, FL ...
Oral Drugs·3,354 affected·Jan 18, 2017
High RiskFDA
Vistapharm, Inc.
Phenytoin Oral Suspension, USP 100 mg/ 4 mL, 50 unit dose cups of 4 mL per case., Rx only, Manufactured by VistaPharm, Largo, FL 33771, N...
Oral Drugs·12,059 affected·Jan 18, 2017
High RiskFDA
Vistapharm, Inc.
Potassium Chloride Oral Solution, USP, 10%, 20 mEq per 15 mL, packaged in 15 mL unit dose cups (NDC 66689-047-01), 50 unit dose cups per...
Oral Drugs·13,609 affected·Jan 18, 2017
High RiskFDA
Vistapharm, Inc.
Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL, a). 5 mL, 50 unit dose cups of 5 mL per case (NDC No. 66689-401-50), b). 500 mL, 12...
Oral Drugs·42,776 affected·Jan 18, 2017
High RiskFDA
Vistapharm, Inc.
Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II (Sugar Free), 1 liter (1000 mL), 4 bottles per case, Rx only, Manufactured by...
Oral Drugs·14,368 affected·Jan 18, 2017
High RiskFDA
Vistapharm, Inc.
Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II, a.) 1 fl. oz. (30 mL), 12 bottles per case (NDC No. 66689-695-30), b). 1 lit...
Oral Drugs·127,193 affected·Jan 18, 2017
High RiskFDA
Vistapharm, Inc.
Nystatin Oral Suspension, USP 100,000 units per mL, a) 2 fl. oz. (60 mL), 24 bottles per case (NDC 66689-008-02), b) 16 fl. oz. (237 mL),...
Oral Drugs·67,955 affected·Jan 18, 2017
High RiskFDA
Philips Electronics North America Corporation
Philips Healthcare Brilliance iCT X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cros...
Medical Devices·606 affected·Jan 18, 2017
High RiskFDA
Argon Medical Devices, Inc
HARVEST NEEDLE 15GA X 2 Intended for the purpose of harvesting bone and/or bone marrow specimens
Medical Devices·15 affected·Jan 18, 2017
High RiskFDA
Biomerieux Sa
ETEST XM256 (Cefuroxime), Foam: 506958-506918; SPB: 412304-412305 ETEST is a quantitative technique for determining the antimicrobial ...
Medical Devices·7,160 affected·Jan 18, 2017
High RiskFDA
Raysearch Laboratories Ab
Radiation Therapy Treatment Planning System, Model 4.5, 4.7, 5.0 RayStation is a software system designed for treatment planning and ana...
Medical Devices·741 affected·Jan 18, 2017
High RiskFDA
Argon Medical Devices, Inc
T-LOK BONE MARROW BIOPSY NEEDLE 8G x 4 EXT CAN; T-LOK BONE MARROW BIOPSY NEEDLE 11G x 4 EXT CAN Intended for the purpose of harvesting...
Medical Devices·772 affected·Jan 18, 2017
RecallFDA
Penn Herb Company, Ltd.
Nature's Wonderland Sinus & Lung Care, 60 VCaps (Capsules), PET bottle
Food·10 affected·Jan 17, 2017
CriticalFDA
Origen Biomedical, Inc.
ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV28F
Medical Devices·66 affected·Jan 17, 2017
High RiskFDA
Philips Electronics North America Corporation
Philips Efficia CMS200 Central Monitoring System; 863352 The Efficia CMS200 central monitoring system is intended for use by healthcare ...
Medical Devices·156 affected·Jan 17, 2017
CriticalFDA
Origen Biomedical, Inc.
ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV19F
Medical Devices·61 affected·Jan 17, 2017
High RiskFDA
Medtronic Neurosurgery
Medtronic Strata II / Strata NSC Valves (includes Burr Hole and Lumbar Peritoneal. All Catalog Numbers. Strata-type valves are used i...
Cardiac Devices·315,997 affected·Jan 17, 2017
CriticalFDA
Origen Biomedical, Inc.
ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV13F
Medical Devices·145 affected·Jan 17, 2017
High RiskFDA
Pentax Of America Inc
Video Duodenoscope These instruments are intended to provide optical visualization of (via a video monitor), and therapeutic access to...
Medical Devices·2,015 affected·Jan 17, 2017
Medium RiskFDA
Leo Pharma Inc
Taclonex (calcipotriene and betamethasone dipropionate) Topical Suspension, 0.005%/0.064%, packaged in (a) 60 g (NDC 50222-501-06), and ...
Topical Drugs·189,610 affected·Jan 16, 2017
RecallFDA
Vintage Pharmaceuticals Llc Dba Qualitest Pharmaceuticals
DEXAMETHASONE ELIXIR, USP, 0.5 mg/5 mL, 8 fl.oz., Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL, NDC 0603-1147-56
Drugs·2,568 affected·Jan 16, 2017
High RiskFDA
Physio-control, Inc.
LIFEPAK 12 Defibrillator/Monitor with End-Tidal CO2 option. The device is used in various areas of the hospital such as critical area...
Cardiac Devices·7 affected·Jan 16, 2017
High RiskFDA
Physio-control, Inc.
LIFEPAK 15 Monitor/Defibrillator with End-Tidal CO2 option. Intended for use by trained medical personnel in out-of-doors and indo...
Cardiac Devices·2,584 affected·Jan 16, 2017
High RiskFDA
Becton Dickinson & Company
BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tube (4.5 ml x 13 x 75 mm) Catalog Number: 369714 Product Usage: The ...
Diagnostic Devices·1,488,800 affected·Jan 16, 2017
High RiskFDA
Med-hot Thermal Imaging, Inc.
MEDHOT MTI 2000 THERMAL IMAGING SYSTEM - TotalVision software with Elevated Body Temperature Screening module, for use as a medical diagn...
Diagnostic Devices·12 affected·Jan 14, 2017
High RiskFDA
The Pictsweet Company
PICTSWEET(R) FARMS, Southern Classics, Crunchy Breaded Okra, NET WT 12 OZ (340g), UPC 7056098377
Bakery & Grains·27,210 affected·Jan 13, 2017
High RiskFDA
Pier Fish Company, Inc.
Frozen Ground Tuna. Product is labeled in part: "PIER FISH CO. 68 CONWAY ST NEW BEDFORD, MA 02740 COLUMBUS FISH & SFD TUNA GRIND LOT# 161...
Seafood·34 affected·Jan 13, 2017
High RiskFDA
Abbvie Inc.
Duopa (carbidopa and levodopa enteral suspension), 4.63 mg/20 mg per mL, 100 mL cassette, 7 cassettes per carton, Rx Only, AbbVie Inc., N...
Drugs·4,021 affected·Jan 13, 2017
CriticalFDA
Physio-control, Inc.
The LIFEPAK 1000 defibrillator is intended for use by personnel who are authorized by a physician/medical director and are trained in CPR...
Cardiac Devices·133,330 affected·Jan 13, 2017
High RiskFDA
Won Industry Co.
Compressible Limb Therapy System (Leg Cuffs, Arm Sleeves, Waist pads and air injection hoses) Product Usage: Intended for limb massag...
Medical Devices·3 affected·Jan 13, 2017
CriticalFDA
Hy-vee Stores Inc
Chocolate almond pretzels packaged in 4 oz. (UPC 026131900000) and 12 oz. (UPC 026131800000) plastic tray containers for retail sale, lab...
Snacks & Candy·2,460 affected·Jan 12, 2017
CriticalFDA
Hy-vee Stores Inc
Chocolate almond bark packaged in 4 oz. (UPC 026133400000) and 12 oz. (UPC 021633300000) plastic tray containers for retail sale, labeled...
Snacks & Candy·639 affected·Jan 12, 2017
CriticalFDA
Hy-vee Stores Inc
Cookie & Candy packaged in a 9"/16oz. (UPC 026138600000), 12" /32 oz. (UPC 026138700000), and 16"/48 oz. (UPC 026138800000) plastic tray...
Bakery & Grains·3,317 affected·Jan 12, 2017
High RiskFDA
Los Chileros De Nuevo Mexico, Llc
Los Chileros, Basil Pesto, Net Wt. 6 oz. (170g). plastic shell container. Keep Refrigerated
Food·848 affected·Jan 12, 2017
CriticalFDA
Hy-vee Stores Inc
Candy packaged in a 9"/16oz. (UPC 026138000000), 12" /32 oz. (UPC 026138100000), and 16"/48 oz. (UPC 026138200000) plastic tray containe...
Snacks & Candy·27,307 affected·Jan 12, 2017
CriticalFDA
Hy-vee Stores Inc
Cr¿me De Menthe Almond Bark packaged 12 oz. (UPC 026266300000) plastic tray containers for retail sale, labeled with Hy-Vee scale ticket....
Food·336 affected·Jan 12, 2017
CriticalFDA
Hy-vee Stores Inc
Holiday Candy packaged in a 10"/16oz. (UPC 026139100000), 12" /32 oz. (UPC 026139300000), 16"/48 oz. (UPC 026139500000), and 18"/64 oz. ...
Snacks & Candy·15,940 affected·Jan 12, 2017
CriticalFDA
Hy-vee Stores Inc
Peppermint Bark packaged in 4oz. (UPC 026133800000),12 oz. (UPC 026133700000) plastic tray containers, and 9 oz. tubs (UPC 026267900000) ...
Food·4,107 affected·Jan 12, 2017
Medium RiskFDA
Actavis Inc
Albuterol Sulfate Inhalation Solution, USP, 0.021% (0.63 mg / 3 mL), 3mL Vials, Rx only, Mfd. for Watson Laboratories Inc., Corona, CA 92...
Drugs·164,844 affected·Jan 12, 2017
High RiskFDA
Sun Pharmaceutical Industries, Inc.
Sun Pharma Carbidopa and Levodopa Tablets USP 25 mg/250 mg a) 100-count bottles (NDC 62756-519-88), b) 500-count bottles (NDC 62756-519-1...
Oral Drugs·8,537 affected·Jan 12, 2017
High RiskFDA
Carestream Health Inc
Carestream DRX-Revolution Mobile X-Ray System, Model DRXR-1, Catalog No. 1019397 (all other countries), Catalog No. 1060177 (China only) ...
Medical Devices·1,403 affected·Jan 12, 2017
High RiskFDA
Vascular Solutions, Inc.
GrebSet Micro-Introducer Kit, model 7941, Sterilized with Ethylene Oxide. Product Usage: The GrebSet micro-introducer kit is intende...
Medical Devices·633 affected·Jan 12, 2017
High RiskFDA
Boston Scientific Corporation
Boston Scientific, EMBLEM S-ICD Programmer Model 3200 Programmer.
Medical Devices·4,500 affected·Jan 12, 2017
High RiskFDA
West Coast Laboratories Inc
Xambo, 80 boxes of bulk capsules. Each containing 12,053 capsules in each box.
Food·964,240 affected·Jan 11, 2017
High RiskFDA
Robert Rothschild Farm Llc
Gift Sets with Chocolate Pretzel Dippers
Snacks & Candy·28,288 affected·Jan 11, 2017