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
High RiskFDA
Ivoclar Vivadent, Inc.
Zenostar MT Color Impulse grey, art. no. 681167 Product Usage: For coloring dental porcelain
Medical Devices60 affectedMay 27, 2016
High RiskFDA
Ivoclar Vivadent, Inc.
Zenostar MT Color B3 60ml, art. no. 681057. Product Usage: For coloring dental porcelain
Medical Devices27 affectedMay 27, 2016
High RiskFDA
Ivoclar Vivadent, Inc.
Zenostar MT Color A4 60ml, art. no. 681054. Product Usage: For coloring dental porcelain
Medical Devices11 affectedMay 27, 2016
High RiskFDA
Ivoclar Vivadent, Inc.
Zenostar MT Color Impulse brown, art. no. 681169 Product Usage: For coloring dental porcelain
Medical Devices11 affectedMay 27, 2016
High RiskFDA
Ivoclar Vivadent, Inc.
Zenostar MT Color B1 60ml, art. no. 681055. Product Usage: For coloring dental porcelain
Medical Devices43 affectedMay 27, 2016
High RiskFDA
Ivoclar Vivadent, Inc.
Zenostar MT Color C4 60ml, art. no. 681062. Product Usage: For coloring dental porcelain
Medical Devices10 affectedMay 27, 2016
High RiskFDA
Ivoclar Vivadent, Inc.
Zenostar MT Color D2 60ml, art. no. 681063. Product Usage: For coloring dental porcelain
Medical Devices40 affectedMay 27, 2016
High RiskFDA
Ivoclar Vivadent, Inc.
Zenostar MT Color B4 60ml, art. no. 681058. Product Usage: For coloring dental porcelain
Medical Devices7 affectedMay 27, 2016
RecallFDA
Taro Pharmaceuticals U.s.a., Inc.
Kamedis BIO-HERBAL DANDRUFF CARE THERAPEUTIC 2-STEP DANDRUFF CARE SYSTEM - Kamedis Bio-Herbal Dandruff Care 0.1% PYRITHIONE ZINC, STEP 1...
Drugs17,100 affectedMay 26, 2016
RecallFDA
Stratus Pharmaceuticals Inc
Remeven Cream, (50% Urea in a Cream Base), a) 5.0 oz (142 g) and b) 9.0 oz (255 g) tubes, Rx only, Manufactured by Sonar Products Inc, ...
Topical Drugs12,345 affectedMay 26, 2016
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure
Medtronic, MyCareLink Patient Monitor, Model 24950, Rx Only. The MyCareLink Monitor, Model 24950, is a remote monitoring system that int...
Medical Implants262 affectedMay 26, 2016
High RiskFDA
Exactech, Inc.
Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 17. Product Usage Femoral stems are indicate...
Medical Devices8 affectedMay 26, 2016
High RiskFDA
Smith & Nephew, Inc.
LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 5 LEFT, A/P 62 MM, M/L 70 MM, REF 71421375 The LEGION Hinge Knee System is indicated for: 1. Rhe...
Medical Devices10 affectedMay 26, 2016
High RiskFDA
Smith & Nephew, Inc.
LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 4 LEFT, A/P 58.5 MM, M/L 66 MM, REF 71421374 The LEGION Hinge Knee System is indicated for: 1. R...
Medical Devices33 affectedMay 26, 2016
High RiskFDA
Smith & Nephew, Inc.
LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 3 LEFT, A/P 54.5 MM, M/L 62 MM, REF 71421373 The LEGION Hinge Knee System is indicated for: 1. R...
Medical Devices12 affectedMay 26, 2016
High RiskFDA
Roche Diagnostics Operations, Inc.
ONLINE TDM Vancomycin 100 tests; ONLINE TDM Vancomycin 200 tests; Hitachi Vancomycin (Modular P); Hitachi Vancomycin (917, MOD P) The ...
Diagnostic Devices53,897 affectedMay 26, 2016
High RiskFDA
Smith & Nephew, Inc.
LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 3 RIGHT, A/P 54.5 MM, M/L 62 MM, REF 71421363 The LEGION Hinge Knee System is indicated for: 1. ...
Medical Devices3 affectedMay 26, 2016
High RiskFDA
Magic Seasoning Blends, Llc
OUTBACK STEAKHOUSE OSI Mama's Batter, Qty 40lbs, NET WEIGHT 40 lbs, MFG FOR: OSI, TAMPA, FL 33609
Food18,720 affectedMay 25, 2016
High RiskFDA
Magic Seasoning Blends, Llc
TASTE BUDS SEASONED FLOUR, ITEM# ZEAON1040, NET WT. 40 LBS.
Food5,120 affectedMay 25, 2016
High RiskFDA
Magic Seasoning Blends, Llc
OUTBACK STEAKHOUSE COMPLETE BREADING MIX, NET WEIGHT 40 lbs, Mfg By: Magic Seasoning Blends, Inc., Harahan, LA 70123
Bakery & Grains3,322 affectedMay 25, 2016
High RiskFDA
Magic Seasoning Blends, Llc
WOW 101 TENDER BATTER, NET WT. 25 lbs, ITEM #: WOW101TNBT025
Food325 affectedMay 25, 2016
High RiskFDA
Magic Seasoning Blends, Llc
ONION BREADER, NET WEIGHT 25 lbs, MFG FOR: LEE ROY SELMONS, TAMPA, FL 33609
Bakery & Grains9,900 affectedMay 25, 2016
High RiskFDA
Lactalis American Group, Inc.
PRESIDENT brand Authentic Pub Cheese SPREADABLE CHEESE, Cheddar & Porter Ale, Net Wt. 8 oz. (226g), UPC 070153229047 --- Dist. by Lactali...
Dairy17,856 affectedMay 25, 2016
High RiskFDA
Magic Seasoning Blends, Llc
OUTBACK STEAKHOUSE CRAWFISH/CHICKEN/CALAMARI BREADER, NET WEIGHT 40 lbs, Mfg By: Magic Seasoning Blends, Inc., Harahan, LA 70123
Meat & Poultry3,320 affectedMay 25, 2016
RecallFDA
Sandoz Inc
Lisinopril Tablets USP, 30 mg, 100-count bottle, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08540, NDC 0185-0630-01
Oral Drugs3,048 affectedMay 25, 2016
High RiskFDA
Merge Healthcare, Inc.
iConnect Access software. The firm name on the label is Merge Healthcare, Hartland, WI.
Medical Devices60 affectedMay 25, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
BrightView XCT Model 882482, gamma camera for Single Photon Emission Computed Tomography (SPECT)
Medical Devices424 affectedMay 25, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
BrightView XCT Upgrade Model 882454
Medical Devices3 affectedMay 25, 2016
CriticalFDA
Windy Acres Candy & Nut, Outlet Inc.
Windy Acres FRUITY TRAIL MIX Roasted Peanuts, Pineapple, Papaya, Raisins & Almonds 7 OZ (198 G) UPC 0 82987 02016 5 WILMINGTON, OH 45177 ...
Produce79 affectedMay 24, 2016
High RiskFDA
Grain Craft, Inc.
Donut Flour, Net Wgt. 50 lbs. (22.68 kgs.), Mfg. By: Grain Craft, Birmingham, AL 35214.
Food279,514 affectedMay 24, 2016
CriticalFDA
Garden-fresh Foods, Inc.
Eillien's Salted Sunflower Kernels Net WT 4 oz (113G) sealed in original plastic packaging and contained in Garden Fresh Foods, Cool Bre...
Produce221 affectedMay 24, 2016
High RiskFDA
Grain Craft, Inc.
Unenriched Pastry Flour, (M1613, R100258001), Net Wgt. 50 lbs. (22.68 kgs.), Mfg. By: Grain Craft, Birmingham, AL 35214.
Bakery & Grains279,514 affectedMay 24, 2016
CriticalFDA
Windy Acres Candy & Nut, Outlet Inc.
ROAST, NO SALT SUNFLOWER SEEDS sold under the following brands: Jungle Jim 16oz (453G) INGREDIENTS: SUNFLOWER SEEDS ROASTED IN SUNFLOWER...
Food9 affectedMay 24, 2016
High RiskFDA
Grain Craft, Inc.
Bojangles Chicken Breading Flour (12248), Net Wgt. 50 lbs. (22.68 kgs.), Mfg. By: Grain Craft, Birmingham, AL 35214.
Meat & Poultry279,514 affectedMay 24, 2016
High RiskFDA
Grain Craft, Inc.
Pastry Flour (BRMOO20, M1633, 825, R000110690), Net Wgt. 50 lbs. (22.68 kgs.), Mfg. By: Grain Craft, Birmingham, AL 35214.
Bakery & Grains279,514 affectedMay 24, 2016
High RiskFDA
Grain Craft, Inc.
Craft Cake Flour (M4138), Net Wgt. 50 lbs. (22.68 kgs.), Mfg. By: Grain Craft, Birmingham, AL 35214.
Bakery & Grains279,514 affectedMay 24, 2016
CriticalFDA
Garden-fresh Foods, Inc.
Eillien's Salted Sunflower Kernels Net WT 4 oz (113G) sealed in original plastic packaging and contained in Garden Fresh Foods Broccoli ...
Produce13 affectedMay 24, 2016
High RiskFDA
Grain Craft, Inc.
Cookie/Cracker Flour, EN, BL C, Bulk
Bakery & Grains279,514 affectedMay 24, 2016
High RiskFDA
Grain Craft, Inc.
Soft Wheat Flour EN Bulk
Food279,514 affectedMay 24, 2016
High RiskFDA
Grain Craft, Inc.
Soft Whole Wheat Flour, Bulk
Food279,514 affectedMay 24, 2016
High RiskFDA
En-r-g Foods, Inc.
Protein Chews Raspberry,1.8oz, film package, 12 packets per box.
Produce103,354 affectedMay 24, 2016
High RiskFDA
Grain Craft, Inc.
SOFT WHOLE WHEAT FLOUR BULK
Food279,514 affectedMay 24, 2016
CriticalFDA
Garden-fresh Foods, Inc.
Eillien's Salted Sunflower Kernels Net WT 4 oz (113G) sealed in original plastic packaging and contained in Garden Fresh Foods Cool Bree...
Food126 affectedMay 24, 2016
High RiskFDA
Grain Craft, Inc.
Graham, Net Wgt. 50 lbs. (22.68 kgs.), Mfg. By: Grain Craft, Birmingham, AL 35214.
Food279,514 affectedMay 24, 2016
High RiskFDA
Grain Craft, Inc.
Soft Wheat Flour-EN BL C-LVL 4.7 Bulk
Food279,514 affectedMay 24, 2016
High RiskFDA
En-r-g Foods, Inc.
Protein Chews Juneberry,1.8oz, film package, 12 packets per box.
Produce40,079 affectedMay 24, 2016
High RiskFDA
Grain Craft, Inc.
Kraft Cake Flour (110760), Net Wgt. 50 lbs. (22.68 kgs.), Mfg. By: Grain Craft, Birmingham, AL 35214.
Bakery & Grains279,514 affectedMay 24, 2016
High RiskFDA
Grain Craft, Inc.
Kraft Cake Flour (110760), Net Wgt. 50 lbs. (22.68 kgs.), Mfg. By: Grain Craft, Birmingham, AL 35214.
Bakery & Grains279,514 affectedMay 24, 2016