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

Have an unsafe medication, device, or food to report?

Filing a report with the FDA is free and takes a few minutes. Consumer reports drive future recalls and help the agency identify safety patterns.

How to report to FDA →
68,659 recalls
High RiskFDA
C.r. Bard, Inc.
Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 12 Fr, (30/box), Product Code 51612. Intermittent catheter.
Surgical Devices·91,140 affected·Jul 7, 2015
High RiskFDA
Eizo Corporation
RadiForce GX540, 5MP Monochrome LCD Monitor, Part Code No. 0FTD1826A5, 0FTD1826B5, 0FTD1826C5, UPC 690592034752. This product is intende...
Medical Devices·19 affected·Jul 7, 2015
High RiskFDA
C.r. Bard, Inc.
Magic3 Hydrophilic-coated Female Intermittent Urinary Catheter 14 Fr in the Insertion Supply Kit, Product Code 51614S. Intermittent ca...
Surgical Devices·534,972 affected·Jul 7, 2015
High RiskFDA
Eizo Corporation
RadiForce RX650, 6MP Color LCD Monitor, Part Code No. 0FTD1957A5, 0FTD195B5, UPC 690592037203. This product is intended to be used in di...
Medical Devices·3 affected·Jul 7, 2015
High RiskFDA
C.r. Bard, Inc.
Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 14 Fr, (30/box), Product Code 51614. Intermittent catheter.
Surgical Devices·37,686 affected·Jul 7, 2015
High RiskFDA
Eizo Corporation
RadiForce RX850, 8MP Color LCD Monitor, Part Code No. 0FTD1958A2, UPC 690592037180. This product is intended to be used in displaying an...
Medical Devices·2 affected·Jul 7, 2015
RecallFDA
Mason Vitamins, Inc.
Coenzyme Q-10 50 mg label reads in part, "***Major***CO Q-10 50 MG***For healthy HEART & IMMUNE function***Promotes ENERGY in all Body Ce...
Supplements·13,027 affected·Jul 6, 2015
High RiskFDA
Chemi-source, Inc.
DHEA 25mg, 60 count, sku: #6-09492-41001-6, and 90 count, sku: #6-09492-41002-3; 12 bottles/case.
Food·5,977 affected·Jul 6, 2015
RecallFDA
Biocomp Pharma, Inc.
Maximum Strength Analgesic Thera-Gesic Pain Relieving Creme Relief from: Joint and Muscle Soreness, Arthritis, Back Aches; 1/8 Oz Sachet,...
Drugs·40,000 affected·Jul 6, 2015
CriticalFDA
Philips Electronics North America Corporation
SENSE Body Coil 1.5T with identification; used in the ACS NT, Intera 1.5T and Achieva 1.5T MR system
Medical Devices·5,672 affected·Jul 6, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
Syngo.plaza; picture archiving and communications system Product Usage: Syngo.plaza is a Picture Archiving and Communication System (...
Medical Devices·37 affected·Jul 6, 2015
High RiskFDA
Philips Electronics North America Corporation
Actuator for angiographic x-ray monitor ceiling suspension system. Actuator short Assy: THC8AWDS-121 and Actuator long Assy: THC8AWDS-12...
Medical Devices·3,158 affected·Jul 6, 2015
High RiskFDA
Nordicneurolab As
nordicICE v 2.3.14 nordicICE is an image processing software package to be used by trained professionals including but not limited to ...
Respiratory Devices·121 affected·Jul 3, 2015
High RiskFDA
Barilla America Ny, Inc.
Barilla MEDIUM SHELLS, 1 LB (454 g), GTIN 00076808002881, packed as twelve boxes in 1 case
Food·43 affected·Jul 2, 2015
High RiskFDA
Barilla America Ny, Inc.
Barilla Packaged Specifically for FoodService, PENNE RIGATE, 160 OZ (10 LBS) (4.54 kg), GTIN 1007680839242, packed as two bags per case.
Food·6,178 affected·Jul 2, 2015
CriticalFDA
Brett Anthony Foods
Vegetable Chili, 8 oz plastic container, labeled with a green and white label with green and white lettering.
Produce·2 affected·Jul 2, 2015
High RiskFDA
Barilla America Ny, Inc.
Barilla PENNE, 8 X 1 LB (454 g) BOXES, [NET WT. 8 LB (3.63 kg)], GTIN 10076808034360, packed as a Multi-unit box, 8 units per case for s...
Food·9,360 affected·Jul 2, 2015
CriticalFDA
Arthur Schuman Inc.
Bella Rosa Parmesan Net Wt. 20 oz (567 g) 1.25 LB Arthur Schuman, Inc. Fairfield, NJ 07064 UPC 088231410041
Food·26,075 affected·Jul 2, 2015
High RiskFDA
Barilla America Ny, Inc.
Barilla Pronto PENNE, 12 OZ (340 g), GTIN number 10076808005605, packed as 16 boxes per case, sold as individual units at retailer.
Food·82 affected·Jul 2, 2015
High RiskFDA
Hospira Inc.
0.9% Sodium Chloride Injection USP, 50 mL ADD-Vantage Unit, Rx only, Manufactured by Hospira, Inc., Ausitn, TX 78728, NDC 00409-7101-68
Injectable Drugs·314,600 affected·Jul 2, 2015
Medium RiskFDA
Bestco, Inc.
CVS SUGAR FREE BLACK CHERRY COUGH DROPS (MENTHOL-COUGH SUPPRESSANT), Packaged in a) 25 Drop Bags (UPC: 050428 448526) and b) 36 drop bags...
Drugs·149,856 affected·Jul 2, 2015
High RiskFDA
Baxter Healthcare Corp.
0.9% Sodium Chloride Injection USP, 500 mL in VIAFLEX Plastic Container, Baxter Healthcare Corporation Deerfield, IL 60015, NDC 0338-00...
Injectable Drugs·189,912 affected·Jul 2, 2015
CriticalFDA
Xtreme Z Distributors Inc
Zero Xtreme High Performance Fat Burner capsules, 30-count bottle, Distributed by Xtreme Z Distributors, Inc., Miami, FL 33180
Oral Drugs·70,350 affected·Jul 2, 2015
CriticalFDA
Cook Inc.
Beacon Tip Royal Flush Plus High-Flow Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the deli...
Surgical Devices·268,169 affected·Jul 2, 2015
High RiskFDA
Mrp, Llc Dba Amusa
0.9% Sodium Chloride Injection, USP, 10mL in 12mL., Single use, Rx only, Sterile Solution.
Medical Devices·551 affected·Jul 2, 2015
CriticalFDA
Cook Inc.
Slip-Cath Beacon Tip Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast ...
Surgical Devices·248,167 affected·Jul 2, 2015
High RiskFDA
Stryker Medical Division Of Stryker Corporation
Spirit One A-C Powered Hospital Bed
Medical Devices·143 affected·Jul 2, 2015
High RiskFDA
Stryker Medical Division Of Stryker Corporation
Spirit One A-C Powered Hospital Bed
Medical Devices·143 affected·Jul 2, 2015
High RiskFDA
Silhouette Lift, Inc.
Silhouette Lift brochure Silhouette Sutures are for use in midface suspension surgery to fixate the cheek subdermis in an elevated pos...
Medical Devices·2,260 affected·Jul 2, 2015
CriticalFDA
Cook Inc.
Beacon Tip Torcon NB Advantage Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of c...
Surgical Devices·451,550 affected·Jul 2, 2015
CriticalFDA
Whole Food Market
Peach Pie 9 Inch NET WT. 2lb 4oz (1021g) and Peach Pie Half NET WT. 1lb 1oz (482g) and individual slices
Food·11 affected·Jul 1, 2015
CriticalFDA
Whole Food Market
Cherry Pie 9 Inch NET WT. 2lb 4oz (1021g) and Cherry Pie Half NET WT. 1lb 1oz (482g) and individual slices
Food·20 affected·Jul 1, 2015
CriticalFDA
Whole Food Market
Blackberry Pie 9 Inch NET WT. 2lb 4oz (1021g) and Blackberry Pie Half NET WT. 1lb 1oz (482g) and individual slices.
Produce·3 affected·Jul 1, 2015
High RiskFDA
Buckwheat Enterprises, Inc
All You Need Bread, Each loaf is package in a bag with a net wt. 1 lb. 14 oz., sold under brand Great Harvest Bread Co.
Bakery & Grains·174 affected·Jul 1, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
GEMINI TF Big Bore CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomog...
Diagnostic Devices·44 affected·Jul 1, 2015
High RiskFDA
Elekta, Inc.
MOSAIQ Oncology Information System MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery...
Medical Devices·74 affected·Jul 1, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
GEMINI TF 16 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomog...
Diagnostic Devices·13 affected·Jul 1, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
GEMINI GXL 16 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomo...
Diagnostic Devices·2 affected·Jul 1, 2015
High RiskFDA
Myoscience Inc
iovera 155 Smart Tip; Catalog numbers:STT0412-10 and STT0412-5 (10 and 5 count respectively) iovera Smart Tips are individually pac...
Surgical Devices·12 affected·Jul 1, 2015
High RiskFDA
Michael Foods, Inc.
Crystal Farms Simply Potatoes Shredded Hash Browns packaged as individual plastic bags Net Wt. 20 oz (1 lb 4 oz) 567 g; UPC 0 20169 22233...
Food·3,349 affected·Jun 30, 2015
High RiskFDA
Inn Foods Inc.
IQF Italian Cut Green Beans (each tote 1350 lbs) lot 880804 Harvest Delight Italian Green Beans, (Veg, mixed, FZN, Italian Blend, IQF...
Food·8 affected·Jun 30, 2015
High RiskFDA
Glorybee Inc
Turkish Organic Diced Apricots with Rice Flour (5-7 mm), FOODIMPEX brand, Item# 17496, product is packged in a white cardboard box. Net ...
Food·107 affected·Jun 30, 2015
High RiskFDA
Hospira Inc.
KETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- ...
Drugs·12,460,975 affected·Jun 30, 2015
High RiskFDA
Hospira Inc.
KETOROLAC Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- N...
Drugs·5,214,900 affected·Jun 30, 2015
High RiskFDA
Mylan Pharmaceuticals Inc
Capecitabine Tablets, USP, 500 mg, 120-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-2512-78, UPC 3 0...
Oral Drugs·1,068 affected·Jun 30, 2015
RecallFDA
Glaxosmithkline Consmer Healthcare
Panadol (acetaminophen) Extra Strength, 500 mg, a) 30 count (UPC 1-03-53100-91070-8, NDC 0135-0135-02), b) 60 count (UPC 1-03-53100-91080...
Drugs·17,675 affected·Jun 30, 2015
High RiskFDA
Remel Inc
PathoDx Strep Grouping Kit, REF 62025, packaged 60 tests per kit. Latex agglutination test for identification of beta-hemolytic stre...
Medical Devices·1,859 affected·Jun 30, 2015
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry Acetaminophen reagents; for in vitro diagnostic use in the quantitative determination of acetaminophen in human serum and...
Diagnostic Devices·1,032 affected·Jun 30, 2015