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
Teva Pharmaceuticals Usa
Fentanyl Transdermal System. 25 mcg/h, packaged in 5 pouch system cartons (NDC 0591-3198-72), Rx Only, Manufactured by: Actavis Laborato...
Drugs·1,118,046 affected·Jan 29, 2018
RecallFDA
Teva Pharmaceuticals Usa
Fentanyl Transdermal System, 100 mcg/h, packaged in 5 pouch system (NDC 0591-3214-72), Rx Only, Manufactured by: Actavis Laboratoies UT,...
Drugs·554 affected·Jan 29, 2018
Medium RiskFDA
Teva Pharmaceuticals Usa
Fentanyl Transdermal System, 50 mcg/h, packaged in 5 pouch system cartons (NDC 0591-3212-72), Rx Only, Manufactured by: Actavis Laborato...
Drugs·929,916 affected·Jan 29, 2018
RecallFDA
Mckesson Packaging Services
Megestrol Acetate Oral Suspension, USP 400 mg/ 10mL (10 mL UD cups in boxes of 20 cups), Rx Only, Dist. By McKesson Packaging Services a ...
Oral Drugs·24,120 affected·Jan 29, 2018
RecallFDA
Dr. Reddy's Laboratories, Inc.
Atorvastatin Calcium Tablets 20 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, IN...
Oral Drugs·28,941 affected·Jan 29, 2018
RecallFDA
Teva Pharmaceuticals Usa
Fentanyl Transdermal System. 75 mcg/h, packaged in 5 pouch system (NDC 0591-3213-72), Rx Only, Manufactured by: Actavis Laboratoies UT, ...
Drugs·576 affected·Jan 29, 2018
High RiskFDA
Encore Medical, Lp
Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 50mm, REF 804-07-500 Product Usage: The AltiVate Anatomic Shoulder ...
Medical Devices·92 affected·Jan 29, 2018
High RiskFDA
Encore Medical, Lp
Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 54mm, REF 804-07-540 Product Usage: The AltiVate Anatomic Shoul...
Medical Devices·93 affected·Jan 29, 2018
High RiskFDA
Encore Medical, Lp
Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 46mm, REF 804-07-460 Product Usage: The AltiVate Anatomic Shoulder ...
Medical Devices·92 affected·Jan 29, 2018
High RiskFDA
Philips Electronics North America Corporation
Philips QCPR Meter - used with FR3 Product Usage: The Philips CPR meter is intended for use with the Philips HeartStart FR3 automated...
Cardiac Devices·28,094 affected·Jan 29, 2018
RecallFDA
Iq Produce, Llc
Fresh Fragrant Pear; Label - Double Trees Product of China Shenzhen J.F. Fruit Co., LTD
Produce·2,402 affected·Jan 27, 2018
CriticalFDA
Primus Pharmaceuticals, Inc.
Limbrel (flavocoxid 500 mg) capsules, 60-count bottle, Rx only, Manufactured for: Primus Pharmaceuticals, Inc., Scottsdale, AZ 85253; Ma...
Oral Drugs·135,277 affected·Jan 26, 2018
CriticalFDA
Primus Pharmaceuticals, Inc.
Limbrel (flavocoxid 250 mg) capsules, 60-count bottle, Rx only, Manufactured for: Primus Pharmaceuticals, Inc., Scottsdale, AZ 85253; Ma...
Oral Drugs·7,826 affected·Jan 26, 2018
CriticalFDA
Primus Pharmaceuticals, Inc.
Limbrel250 (flavocoxid and citrated zinc bisglycinate) 250 mg/50 mg capsules, 60-count bottle, Rx only, Manufactured for: Primus Pharmac...
Oral Drugs·4,006 affected·Jan 26, 2018
CriticalFDA
Primus Pharmaceuticals, Inc.
Limbrel500 (flavocoxid and citrated zinc bisglycinate) 500 mg/50 mg capsules, 60-count bottle, Rx only, Manufactured for: Primus Pharmace...
Oral Drugs·160,489 affected·Jan 26, 2018
High RiskFDA
Ion Beam Applications S.a.
Proteus 235, ProteusPLUS or Proteus ONE produces and delivers a proton beam for the treatment of patients with localized tumors and other...
Medical Devices·5 affected·Jan 26, 2018
CriticalFDA
Biomerieux, Inc.
bioMerieux VITEK 2 Gram Positive Cefoxitin Screen, VITEK 2 Gram Positive AST for Oxacillin, VITEK SYSTEMS General Susceptibility Card ...
Diagnostic Devices·13,961,320 affected·Jan 26, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc.
Biograph Horizon - PET/CT, PETsyngo VJ20A Software Nuclear medicine/ xray diagnostic scanner.
Diagnostic Devices·42 affected·Jan 26, 2018
High RiskFDA
Raysearch Laboratories Ab
Ray Station 4.9 Ray Station 5, Ray Station 6 and Ray Station 7 Software build numbers: 4.9.0.42, 5.0.0.37, 5.0.1.11, 5.0.2.35, 6.0.0.24, ...
Medical Devices·2,484 affected·Jan 26, 2018
High RiskFDA
Stryker Communications
Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a component of Berchtold Chromophare Ceiling Mounted Surgical Light Sy...
Surgical Devices·850 affected·Jan 26, 2018
High RiskFDA
General Mills, Inc
Larabar Chocolate Chip Cookie Dough, 5 - 1.6 oz (45g) bars Net Wt 8.0 oz(226g), UPC 21908-48817. Case UPC 000-21908-41675-5
Bakery & Grains·147 affected·Jan 25, 2018
High RiskFDA
Coblentz Distributing Inc Dba Walnut Creek Foods
WALNUT CREEK FOODS Caramel Popcorn NET WT 15 OZ (425g) Ingredients: Evaporated Can Juice, Popcorn, Butter (cream, salt), Salt, Sodium Bic...
Dairy·324 affected·Jan 25, 2018
High RiskFDA
Pd-rx Pharmaceuticals, Inc.
PD-Rx Pharmaceuticals Incorporated Ibuprofen 200 mg tablets a) 24 tablets NDC 55289-673-24; b) 30 tablets NDC 55289-673-30; c) 50 tablets...
Oral Drugs·7,174 affected·Jan 25, 2018
High RiskFDA
Ge Healthcare
Centricity PACS-IW with Universal Viewer Product Usage: Usage: Centricity PACS-IW with Universal Viewer is a device that displays me...
Medical Devices·44 affected·Jan 25, 2018
High RiskFDA
Stryker Corporation
CMI (Collagen Meniscus Implant) device, Ivy Sports Medicine s collagen-based meniscus implant Product Usage: The CMI device, Ivy Spor...
Medical Implants·155 affected·Jan 25, 2018
CriticalFDA
Panera, Llc
Panera Reduced-Fat Plain Cream Cheese, 2 oz. and 8 oz.
Dairy·120,783 affected·Jan 24, 2018
High RiskFDA
Bell Plantation Inc.
Ready-to-Eat Powdered Peanut Butter in 1 lb (16 oz.) plastic jars
Dairy·6,011 affected·Jan 24, 2018
CriticalFDA
Panera, Llc
Panera Plain Cream Cheese, 2 oz. and 8 oz.
Dairy·120,783 affected·Jan 24, 2018
CriticalFDA
Panera, Llc
Reduced-Fat Wild Blueberry Cream Cheese, 2 oz. and 8 oz.
Dairy·120,783 affected·Jan 24, 2018
CriticalFDA
Panera, Llc
Panera Chive&Onion Reduced Fat Cream Cheese Spread, 2 oz. and 8 oz.
Dairy·120,783 affected·Jan 24, 2018
CriticalFDA
Panera, Llc
Panera Reduced-Fat Honey Walnut Cream Cheese, 2 oz. and 8 oz.
Dairy·120,783 affected·Jan 24, 2018
RecallFDA
Jcb Laboratories Llc
Cefuroxime, Ophthalmic Solution for Injection, 10 mg/mL, 0.3 mL single-use syringe. This is a Compounded Drug, Hospital & Office Use Onl...
Injectable Drugs·6,510 affected·Jan 24, 2018
RecallFDA
Oxygen Development Llc
Life Brand Clear Action Acne Treatment Concealer Stick (Salicylic acid), 1.9g, Imported for: Shoppers Drug Mart Pharmaprix Toronto, M2J4W...
Drugs·12,216 affected·Jan 24, 2018
High RiskFDA
Mindray Ds Usa, Inc. Dba Mindray North America
Hematology Diluent M-30D used with BC-3200 and BC-3600 Hematology Analyzer; Part Numbers: (1) 105-005405-00 (2 x 5.5L container), (2) 105...
Medical Devices·4,838 affected·Jan 24, 2018
High RiskFDA
Livanova Usa Inc
VNS Therapy Programming System, Rx Only, Model 3000, v1.0.2.2
Medical Devices·243 affected·Jan 24, 2018
High RiskFDA
Zimmer Biomet, Inc.
Coonrad/Morrey Elbow Implant System humeral assembly 4IN XSML, Item Number: 32-8105-027-04 (UDI: (01)0088902427 4006(17)220731(10)63694912)
Medical Implants·9 affected·Jan 24, 2018
High RiskFDA
Invivo Corporation
DynaCad software consist of an MR Analysis Server software and the viewer workstation software. The MR Analysis software consists of Dyn...
Medical Devices·470 affected·Jan 24, 2018
CriticalFDA
Bulletproof 360 Inc
Bulletproof Unflavored Collagen Protein High Performance Building Blocks Dietary Supplement, packaged in a 16-oz. composite-film bag, UPC...
Dairy·0 affected·Jan 23, 2018
High RiskFDA
Implant Direct Sybron Manufacturing, Llc
Implant Direct, INTERACTIVE HEALING COLLAR, PART NUMBER 6530-15, 5.0mmL: 3.0mmD Platform
Medical Implants·55 affected·Jan 23, 2018
High RiskFDA
3m Company - Health Care Business
3M Bair Hugger(M) Normothermia System, Full Access Underbody Warming Blanket, REF 63500 The 3M Bair Hugger Temperature Management Sys...
Medical Devices·33,108 affected·Jan 23, 2018
High RiskFDA
3m Company - Health Care Business
3M Bair Hugger(M) Normothermia System, Sterile Full Access Underbody, Model 63700 The 3M Bair Hugger Temperature Management System is...
Medical Devices·36 affected·Jan 23, 2018
High RiskFDA
Divine Living
Divine Living Silver with harmonically structured frequencies A Wellness Solution 8 oz Ingredients: Structured Water, Pure Silver West Un...
Beverages·20 affected·Jan 22, 2018
High RiskFDA
Sun Noodle New Jersey, Llc
Sun Noodle brand Tonkotsu Ramen, Packaged in plastic clear clamshell, Banded with Tonkotsu label, distinguishable with a yellow color. (1...
Food·128 affected·Jan 22, 2018
RecallFDA
Ascent Pharmaceuticals, Inc.
Oxycodone Hydrochloride Tablets, USP 15 mg, 100 count bottles, Rx only, Manufactured for Camber Pharmaceuticals, Inc., Piscataway, NJ, Ma...
Oral Drugs·45,875 affected·Jan 22, 2018
RecallFDA
Abbvie Inc.
Ultane (sevoflurane), 250 mL, Inhalation Anesthetic, Rx only, Manufactured by: AbbVie Inc., North Chicago, IL 60064, USA. NDC 0074-4456-51
Drugs·7,770 affected·Jan 22, 2018
High RiskFDA
Astellas Pharma Us Inc
Mycamine (micafungin) for Injection 100 mg/vial Single-Dose Vial Rx only Marketed by: Astellas Pharma US, Inc. Northbrook, IL 60062, NDC...
Injectable Drugs·63,600 affected·Jan 22, 2018
High RiskFDA
Aesculap Implant Systems Llc
DS Titanium Ligation Clip, used in laparoscopic surgery
Medical Devices·9,621 affected·Jan 22, 2018
High RiskFDA
Sie Ag, Surgical Instrument Engineering
The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser is an ophthalmic surgical laser intend...
Medical Implants·125 affected·Jan 21, 2018