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
www.fda.gov →Official Site
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How to report to FDA →68,659 recalls
CriticalFDA
Siemens Healthcare Diagnostics, Inc.
Microscan plus Negative Breakpoint Combo 4 Sold outside of US only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroSc...
Medical Devices57,600 affectedAug 21, 2013
CriticalFDA
Siemens Healthcare Diagnostics, Inc.
Microscan plus Negative Urine Combo 4 Sold outside of US only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ R...
Medical Devices57,600 affectedAug 21, 2013
CriticalFDA
Siemens Healthcare Diagnostics, Inc.
Microscan Synergies Plus Negative Combo 2 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) -...
Medical Devices2,158 affectedAug 21, 2013
High RiskFDA
Aso, Llc
SHOPKO Waterproof Adhesive Pads Antibacterial. Used for covering minor cuts, scrapes and burns.
Medical Devices37 affectedAug 21, 2013
CriticalFDA
Siemens Healthcare Diagnostics, Inc.
Microscan Synergies Plus Negative Urine Combo 1 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negati...
Medical Devices1,209 affectedAug 21, 2013
CriticalFDA
Siemens Healthcare Diagnostics, Inc.
Microscan rapID/S panels NC3.12 Sold in Japan only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus...
Medical Devices57,600 affectedAug 21, 2013
CriticalFDA
Siemens Healthcare Diagnostics, Inc.
Microscan plus Negative Combo 3 Sold outside of US only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids ...
Medical Devices57,600 affectedAug 21, 2013
CriticalFDA
Hartleys Potato Chip Company Inc
Hartley's Potato Chips Salt & Vinegar 4.5 oz and 2.5 oz bags Hartley's Potato Chip Co., Inc, Lewistown, PA Ingredients: potatoes, ve...
Snacks & Candy4,549 affectedAug 20, 2013
High RiskFDA
Lucy's Kitchen, Inc.
"***SUPERBUDIN"
Food150 affectedAug 20, 2013
High RiskFDA
Lucy's Kitchen, Inc.
"***SUPERPAN***Tu Pan Natural***"
Food6,985 affectedAug 20, 2013
High RiskFDA
Industrias Alimenticias Kern's Y Cia. S.c.a.
Ducal Brand Prepared Sauce Queso/Cheese, UPC 088313-08328-6, Net Wt 4 oz, Product of Guatemala, C.A. Central American product made with q...
Dairy84 affectedAug 20, 2013
High RiskFDA
Mothers Milk Bank
Human breast milk, pasteurized, 4 oz, in bottles; Pasteurized Human Milk,Hospital Grade Milk. Mother's Milk Bank 751 S. Bascom Abe.S...
Dairy70 affectedAug 20, 2013
High RiskFDA
Carestream Health Inc.
Carestream DRX Evolution System (Standard Q) The DRX-Evolution System (Standard Q) is a permanently installed diagnostic x-ray system ...
Diagnostic Devices4 affectedAug 20, 2013
High RiskFDA
Iba Dosimetry Gmbh
iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator) radiological
Medical Devices33 affectedAug 20, 2013
RecallFDA
Bio-rad Laboratories
FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade software used with the EVOLIS Microplate System.
Medical Devices23 affectedAug 20, 2013
CriticalFDA
G. Debbas Chocolatier, Inc.
Professor Zim Zam's Extraordinary Sweets; Dark Chocolate with Sea Salt; All Natural, 55% Cocoa; Net Wt. 0.35 oz (9.9g) Go Picnic: ...
Snacks & Candy162,708 affectedAug 19, 2013
CriticalFDA
G. Debbas Chocolatier, Inc.
Professor Zim Zam's Extraordinary Sweets; Dark Chocolate with Orange; All Natural, 55% Cocoa; Net Wt. 0.35 oz (9.9g) Go Picnic: Di...
Snacks & Candy126,600 affectedAug 19, 2013
CriticalFDA
G. Debbas Chocolatier, Inc.
Professor Zim Zam's Extraordinary Sweets; Dark Chocolate with Rice Crisps; All Natural, 55% Cocoa; Net Wt. 0.35 oz (9.9g) Go Picnic...
Snacks & Candy107,500 affectedAug 19, 2013
High RiskFDA
Roche Diagnostics Operations, Inc.
ACCU-CHECK FastClix Lancing Device. It is intended for use in conjunction with a blood glucose monitoring system.
Diabetes Devices36,332 affectedAug 19, 2013
High RiskFDA
Lumenis, Inc.
Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. Intended for use in the treatment of ocular pathology.
Medical Devices3 affectedAug 19, 2013
CriticalFDA
See's Candies Inc.
See's Candies, Van Doren Dark Chocolate Blueberries; 8 oz. clear plastic packages. See's Candies Inc./See's Candy Shops Inc: South S...
Snacks & Candy8,327 affectedAug 17, 2013
High RiskFDA
Amneal Pharmaceuticals Of New York, Llc.
Extended Phenytoin Sodium Capsules, USP, 100 mg, 1000 CAPSULES, Rx only, amneal PHARMACEUTICALS label, NDC 65162-212-11 --- Manufactured ...
Oral Drugs895 affectedAug 17, 2013
RecallFDA
Atlantic Pro Nutrients, Inc. Dba Xymogen
LipiChol 540 (Omega-3 Phospholipid) Medical Food Dispense by Prescription Distributed by: PharmaceutiX Orlando, Florida
Food25,852 affectedAug 16, 2013
RecallFDA
Justin's Nut Butter
Chocolate Hazelnut Butter 16oz Jar (Unit UPC 894455000490, Case UPC 894455000612)
Dairy1,512 affectedAug 16, 2013
High RiskFDA
Jean's Cake
Coffee Cake: queso/manzana (cheese/apple)
Dairy0 affectedAug 16, 2013
High RiskFDA
Jean's Cake
Coffee Cake: queso crema (creme cheese)
Dairy0 affectedAug 16, 2013
RecallFDA
Justin's Nut Butter
Maple Almond Butter 16 oz Jar (Unit USPC 894455000322, Case USPC 894455002135)
Dairy5,649 affectedAug 16, 2013
High RiskFDA
Jean's Cake
Coffee Cake: queso/guava (cheese/guava)
Dairy550 affectedAug 16, 2013
High RiskFDA
Jean's Cake
Coffee Cake: queso/fresa (cheese/strawberry)
Dairy0 affectedAug 16, 2013
High RiskFDA
Hospira Inc.
Diazepam Injection, USP, 5 mg/mL, 10 mL, Multiple-dose Sterile Non-pyrogenic, Fliptop Vial, C-IV, Rx Only, Hospira, Inc., Lake Forest, IL...
Injectable Drugs72,300 affectedAug 16, 2013
High RiskFDA
Covidien Llc
Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill Product ID: 8881580123 Product Usage: Both 0.9% Sodium Chlorid...
Medical Devices0 affectedAug 16, 2013
High RiskFDA
Zeppessis Reprocessing, Llc
Zeppessis' reprocessed single-use manifolds (filters) for the Stryker Neptune 1 and Neptune 2 Waste Management Systems: The Neptune Wa...
Surgical Devices0 affectedAug 16, 2013
High RiskFDA
Covidien Llc
Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 10 mL Fill Product ID: 8881570121 Product Usage: Both 0.9% Sodium Ch...
Medical Devices3,235,860 affectedAug 16, 2013
High RiskFDA
Covidien Llc
Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 5 mL Fill Product ID: 8881590125 Product Usage: Both 0.9% Sodium Chlo...
Medical Devices330,120 affectedAug 16, 2013
High RiskFDA
Covidien Llc
Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill Product ID: 8881590123 Product Usage: Both 0.9% Sodium Chlori...
Medical Devices0 affectedAug 16, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc.
Symbia S, Product Usage 1) SPECT: To Detect or image the distribution of radionuclides in the body or organ, using the following techn...
Medical Devices732 affectedAug 16, 2013
High RiskFDA
Access Scientific Inc
POWERWAND Safety Introducer with Extended Dwell Catheter; Catalog no. 92006. Used to gain access to the vascular system to sample blo...
Surgical Devices160 affectedAug 16, 2013
High RiskFDA
Covidien Llc
Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 5 mL Fill Product ID: 8881580125 Product Usage: Both 0.9% Sodium Chlorid...
Medical Devices0 affectedAug 16, 2013
High RiskFDA
Covidien Llc
Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 10 mL Fill Product ID: 8881590121 Product Usage: Both 0.9% Sodium Chlor...
Medical Devices0 affectedAug 16, 2013
CriticalFDA
Buurma Farms Inc
Buurma Farms Cilantro, fresh, 4 oz bunch, #4889 UPC 0 33383 80104 9
Food468 affectedAug 15, 2013
High RiskFDA
Maquet Cardiovascular Us Sales, Llc
QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000. The QUADROX o...
Cardiac Devices1,182 affectedAug 15, 2013
High RiskFDA
Steris Corporation
Harmony Equipment Management System, Model #603X/80XX, STERIS Corporation, Mentor, OH Harmony Equipment Management Systems (EMS) are u...
Surgical Devices127 affectedAug 15, 2013
CriticalFDA
Fabscout Entertainment, Inc
72HP MAXIMUM POTENCY MALE SEXUAL ENHANCEMENT, Dietary Supplement, supplied in 1 capsule per blister pack, Distributed by: 72HP, Inc. West...
Oral Drugs578 affectedAug 14, 2013
High RiskFDA
Hospira Inc.
Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), packaged in 5 Units x 20 mL Single patient infusion vials per carton, Rx only,...
Injectable Drugs283,150 affectedAug 14, 2013
CriticalFDA
Fabscout Entertainment, Inc
PRO POWER MAX Natural Energy Enhancer, ALL NATURAL HERBS, supplied in 1 capsule per blister pack, Distributed by MSH Distribution LLC
Oral Drugs18 affectedAug 14, 2013
High RiskFDA
Novocol Pharmaceutical Of Canada
Lidocaine Hydrochloride 2% and Epinephrine 1:100,000 Injection, Rx Only, For Dental Block and Infiltration Only, 50 Cartridges per box - ...
Injectable Drugs12,497 affectedAug 14, 2013
CriticalFDA
Fabscout Entertainment, Inc
Evil Root 1200 mg, supplied in 6 capsules per bottle, Manufacturer: Tibet Shengyang Health Medicine Co.,Ltd. Address: No. 98, Min zu Road...
Oral Drugs32 affectedAug 14, 2013
CriticalFDA
Medline Industries, Inc.
HEART CATH CUSTOM PACK; REF: DYNJ39747A; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline...
Cardiac Devices160 affectedAug 14, 2013