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
Pharmedium Services, Llc
fentaNYL Citrate Injection, 50 mcg per mL (100 mcg per 2 mL), 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product c...
Injectable Drugs·53,357 affected·Jul 17, 2015
RecallFDA
Microbiologics Inc
LYFO Disk
Medical Devices·3 affected·Jul 17, 2015
High RiskFDA
Ge Healthcare
Lightspeed 16 CT
Medical Devices·416 affected·Jul 17, 2015
High RiskFDA
Ge Healthcare
PET Discovery LS
Medical Devices·6 affected·Jul 17, 2015
High RiskFDA
Ge Healthcare
PET Discovery ST 16
Medical Devices·18 affected·Jul 17, 2015
High RiskFDA
Becton, Dickinson And Company, Bd Biosciences
BD CD56 PE Cy 7: NCAM16.2 ASR Analyte Specific Reagent, Catalog number 335809 Hematology: The CD 56 antigen promotes homophilic adhe...
Diagnostic Devices·362 affected·Jul 17, 2015
High RiskFDA
Medtronic Navigation, Inc.
Medtronic Passive Biopsy Needle Kit, Part Number 9731754 - Passive Biopsy Fee Per Use (FPU) Kit. The image guided Passive Biopsy Needl...
Medical Devices·1,415 affected·Jul 17, 2015
High RiskFDA
Friendly Ice Cream Corp.
Friendly's Vienna Mocha Chunk Ice Cream Tub, 48 U.S. FL. OZ. UPC: 0-29839 00557-4
Dairy·20,736 affected·Jul 16, 2015
RecallFDA
Mutual Pharmaceutical Company, Inc.
Felodipine Extended-Release Tablets, 2.5 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC 53489-3...
Oral Drugs·25,272 affected·Jul 16, 2015
RecallFDA
Mutual Pharmaceutical Company, Inc.
Felodipine Extended-Release Tablets, 10 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co Inc., Philadelphia, PA --- NDC 53489-370-01
Oral Drugs·63,975 affected·Jul 16, 2015
RecallFDA
Mutual Pharmaceutical Company, Inc.
Felodipine Extended-Release Tablets, 5 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC 53489-3...
Oral Drugs·97,859 affected·Jul 16, 2015
High RiskFDA
Safecor Health, Llc
Phenobarbital/Hyoscyamine/ Atropine/Scopolamine 16.2/0.1037/0.0194/0.0065 mg DONNATAL ELIXIR, 5 ml Cup grape, Alcohol 23.8%, Rx Only, MF...
Drugs·23 affected·Jul 16, 2015
RecallFDA
Mutual Pharmaceutical Company, Inc.
Imipramine HCl Tablets, USP, 50 mg, 100 count bottles, Mfd By: Mutual Pharmaceutical Co., Inc., Philadelphia, PA --- NDC 54738-914-01
Oral Drugs·10,080 affected·Jul 16, 2015
RecallFDA
Mutual Pharmaceutical Company, Inc.
Imipramine HCl Tablets, USP, 25 mg, 100 count bottles, Mfd By: Mutual Pharmaceutical Co., Inc., Philadelphia, PA --- NDC 54738-913-01
Oral Drugs·14,112 affected·Jul 16, 2015
RecallFDA
Mutual Pharmaceutical Company, Inc.
Imipramine HCl Tablets, USP, 10 mg, 100 count bottles, Rx only, Mfd By: Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC 54738-91...
Oral Drugs·5,472 affected·Jul 16, 2015
High RiskFDA
Mako Surgical Corporation
Robotic Arm Interactive Orthopedic (RIO) system component PN#205143 (locking pin) and PN# 112220 (connector). Indicated for use in surg...
Surgical Devices·1,322 affected·Jul 16, 2015
High RiskFDA
Otto Bock Healthcare Gmbh
Ottobock Pheon 3R62 Knee Joint The 3R62 Pheon is a polycentric prosthetic knee joint intended to be used solely for lower limb prosthe...
Medical Implants·518 affected·Jul 16, 2015
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Naturalyte Liquid Bicarbonate Concentrate 6.4 liter bottle A Dialysate Concentrate for Hemodialysis (liquid) Product Code: 08-4000-LB
Medical Devices·2,264,028 affected·Jul 16, 2015
High RiskFDA
Radiometer America Inc
Radiometer Fixation Kit N20 for the TCM CombiM monitoring system, REF 905-873. The Fixation Kit N20 is used to apply tc Sensor 84 and...
Respiratory Devices·4,244 affected·Jul 16, 2015
CriticalFDA
Covidien Lp (formerly Nellcor Puritan Bennett Inc.)
Puritan Bennett 980 Ventilator System, Universal (with neonatal functionality enabled) and Neonatal Models. Designed for use on Neonat...
Respiratory Devices·657 affected·Jul 16, 2015
High RiskFDA
National Frozen Foods Corporation--seattle
Italian Vegetable Blend. Product is frozen, not ready to eat, label carries cooking instruction. Label reads in part "***SIMPLOT ...
Produce·215,616 affected·Jul 15, 2015
High RiskFDA
National Frozen Foods Corporation--seattle
Italian Vegetable Blend. Product is frozen, not ready to eat, label carries cooking instruction. Label reads in part "***MARKON F...
Produce·1,719 affected·Jul 15, 2015
High RiskFDA
National Frozen Foods Corporation--seattle
Italian Vegetable Blend. Product is frozen, not ready to eat, label carries cooking instruction. Label reads in part Case"***Sysco...
Produce·932 affected·Jul 15, 2015
High RiskFDA
National Frozen Foods Corporation--seattle
Italian Vegetable Blend. Product is frozen, not ready to eat, label carries cooking instruction. Label reads in part "***GARDEN F...
Produce·3,217 affected·Jul 15, 2015
High RiskFDA
National Frozen Foods Corporation--seattle
Italian Blend. Product is frozen, not ready to eat, label carries cooking instruction. Label reads in part "***FIRST STREET***ITA...
Frozen Food·38,760 affected·Jul 15, 2015
High RiskFDA
National Frozen Foods Corporation--seattle
Italian Vegetable Blend. Product is frozen, not ready to eat, label carries cooking instruction. Label reads in part "***Sysco Cl...
Produce·113,712 affected·Jul 15, 2015
High RiskFDA
National Frozen Foods Corporation--seattle
Italian Green Beans. Product is IQF frozen, not ready to eat, each label carries cooking instructions. Packages sizes: 14 oz.; 16 oz...
Frozen Food·1,052,938 affected·Jul 15, 2015
High RiskFDA
National Frozen Foods Corporation--seattle
Italian Blend. Product is IQF frozen, not ready to eat, each label carries cooking instruction. Label reads in part: "*** market pa...
Produce·124,794 affected·Jul 15, 2015
High RiskFDA
National Frozen Foods Corporation--seattle
Italian Vegetable Blend. Product is frozen, not ready to eat, label carries cooking instruction. Label reads in part Item # 58108...
Produce·72,696 affected·Jul 15, 2015
High RiskFDA
Glaxosmithkline Consmer Healthcare
SENSODYNE EXTRA FRESH REPAIR & PROTECT, 3.4 oz. (96.4 g) tubes, Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSm...
Drugs·335,676 affected·Jul 15, 2015
High RiskFDA
Glaxosmithkline Consmer Healthcare
SENSODYNE EXTRA FRESH COMPLETE PROTECTION, 3.4 oz.(96.4 g) tubes, Manufactured by Oratech, South Jordan UTAH 84095, Distributed by GlaxoS...
Drugs·50,860 affected·Jul 15, 2015
High RiskFDA
Glaxosmithkline Consmer Healthcare
SENSODYNE COMPLETE PROTECTION, 3.4 oz. (96.4 g)tubes, Manufactured by Oratech, South Jordan UTAH 84095, Distributed by GlaxoSmithKline, C...
Drugs·81,376 affected·Jul 15, 2015
High RiskFDA
Glaxosmithkline Consmer Healthcare
biotene PBF Toothpaste (Plaque-Biofilm Loosening Formula), a) 4.3 oz. (121.9 g) tubes, (NDC 0135-0559-01), biotene¿ PBF Paste, b) 4.5 oz....
Drugs·50,860 affected·Jul 15, 2015
High RiskFDA
Glaxosmithkline Consmer Healthcare
biotene Gentle Formula FLUORIDE TOOTHPASTE GENTLE MINT , 4.3 oz.(121.9 g) tubes, Manufactured by Oratech, South Jordan, UTAH, 84095, Dist...
Drugs·111,892 affected·Jul 15, 2015
High RiskFDA
Glaxosmithkline Consmer Healthcare
biotene Gentle Mint Gel, 4.5 oz.(127.6 g) tubes, Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consu...
Topical Drugs·30,516 affected·Jul 15, 2015
High RiskFDA
Glaxosmithkline Consmer Healthcare
biotene Gentle Formula FLUORIDE TOOTHPASTE Fresh Mint Original, a) 0.70 oz (19.8 g) tubes., (NDC 0135-0557-02) , b) 0.75 oz. (21.3 g) tub...
Drugs·366,192 affected·Jul 15, 2015
High RiskFDA
Glaxosmithkline Consmer Healthcare
SENSODYNE WITH FLUORIDE REPAIR & PROTECT, a) 0.8 oz.(23 g) tubes, (NDC 0135-0548-01); b) 3.4 oz. (96.4 g) tubes, (NDC 0135-0548-02) Manu...
Drugs·325,504 affected·Jul 15, 2015
CriticalFDA
Medtronic Cardiovascular Surgery-the Heart Valve Division
EnVeo R Loading System, Model No. LS-EnVeoR-23, LS-EnVeoR-2629, LS-EnVeoR-23-C, LS-EnVeoR-2629-C. Cardiovascular valve delivery sys...
Medical Devices·6,912 affected·Jul 15, 2015
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension¿ CREA (Creatinine) and Dimension Vista¿ CREA (Creatinine); The CREA method used on the Dimension¿ clinical chemistry system is...
Diagnostic Devices·32,165 affected·Jul 15, 2015
CriticalFDA
Supervalu, Inc.
Danish Rolls, 4 Ct., Net Wt. 13oz. in clear plastic clam shell.
Food·1,373 affected·Jul 14, 2015
CriticalFDA
D & D Foods, Inc.
Dijon Mustard Potato Salad, NET WT 3 LB (1.36 kg)
Produce·110 affected·Jul 14, 2015
CriticalFDA
Osamu Corporation
Raw Frozen Saku Tuna Product of Indonesia. The bulk frozen tuna products can be identified from the Purchase Order Number (PO#) pri...
Seafood·0 affected·Jul 14, 2015
CriticalFDA
Osamu Corporation
Raw Frozen Tuna Loin Product of Indonesia. The bulk frozen tuna products can be identified from the Purchase Order Number (PO#) pri...
Seafood·0 affected·Jul 14, 2015
High RiskFDA
Win Luck Trading Inc
Glutinous Rice, Net WT. 1000 g, packaged in plastic bottles, UPC 6958020881168, Made in China
Food·80 affected·Jul 14, 2015
CriticalFDA
Osamu Corporation
Raw Frozen Tuna Chunks Product of Indonesia. The bulk frozen tuna products can be identified from the Purchase Order Number (PO#) p...
Seafood·625 affected·Jul 14, 2015
CriticalFDA
Osamu Corporation
Raw Frozen Ground Tuna Product of Indonesia. The bulk frozen tuna products can be identified from the Purchase Order Number (PO#) p...
Seafood·0 affected·Jul 14, 2015
CriticalFDA
Osamu Corporation
Raw Frozen Sliced Saku Tuna Product of Indonesia. The bulk frozen tuna products can be identified from the Purchase Order Number (P...
Seafood·0 affected·Jul 14, 2015
RecallFDA
Kvk-tech, Inc.
Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 100-count bottle (NDC 10702-0026-01; UPC 3 10702 02601 8) and b) 1000-coun...
Oral Drugs·9,696 affected·Jul 14, 2015