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
Alara Pharmaceutical Co
Levothyroxine Sodium Tablets, USP, 175 mcg in 90 ct bottles, Manufactured by Patheon Puerto Rico Inc., for Alara Pharmaceutical Corp, San...
Oral Drugs·7,432 affected·Oct 29, 2012
CriticalFDA
Michael's Seafood Inc. Dba Michael's Gourmet & Delicacies
Alaskan Wild Smoked Sockeye Salmon in vacuum packed plastic package, labeled in part: "MICHAEL'S WILD SOCKEYE SMOKED...
Seafood·2,440 affected·Oct 27, 2012
CriticalFDA
B.t. Mcelrath Chocolatier, Inc
Peanut Butter Pave, UPC code 693868102117 & 69386905312, in the following sizes: 1) 5 Piece Peanut Butter Pave, 63 Grams per pack, 12 P...
Dairy·6,500 affected·Oct 26, 2012
High RiskFDA
Schoep's Ice Cream Co, Inc
Tub labeled as Kay's Classic Vanilla Bean ice Cream. UPC 87848-13021, 1.5 Quarts (1.42L). Lid labeled as Kay's Classic Toasted Butter P...
Dairy·4,140 affected·Oct 26, 2012
High RiskFDA
Hospira Inc.
Plum A+ Hyperbaric Single Channel Infusion Pumps with Hospira MedNet Software and a Connectivity Engine peripheral module that provides w...
Medical Devices·0 affected·Oct 26, 2012
High RiskFDA
Hospira Inc.
Plum A+ Single Channel Infusion Pumps with Hospira Mednet Software and a Connectivity Engine peripheral module that provides wired Ethern...
Medical Devices·0 affected·Oct 26, 2012
High RiskFDA
Red Chamber Company
Frozen Yellowfin Tuna Loin 3/5, 30lbs/case.
Seafood·750 affected·Oct 25, 2012
CriticalFDA
Csm Bakery Products Na
Murray's WAFFLE CONE DIP, NET WEIGHT - 7 lb 8 oz (3.40 kg), Product Item Code 835462, Bar code 0 06847 66003 2. The product is packaged...
Food·1,973 affected·Oct 25, 2012
High RiskFDA
Hospira Inc.
Epinephrine Injection USP, 1 mL, USP 1:1000 (1 mg/mL), SQ/IM, Hospira, Inc., Lake Forest, IL --- NDC 0409-7241-01
Injectable Drugs·361,600 affected·Oct 25, 2012
High RiskFDA
Quasar Bio-tech, Inc. Dba Silver Bay Llc
Quasar Power Pack contains a Baby Quasar and a Baby Blue. The Baby Quasar is an infrared LED lamp. The Baby Blue uses blue LED light to b...
Medical Devices·7,734 affected·Oct 25, 2012
High RiskFDA
Quasar Bio-tech, Inc. Dba Silver Bay Llc
Baby Quasar (LAB-001-D, BQ101) and Baby Quasar Pink (LAB-046-A BQ101-P) are infrared LED lamps that are labeled in part: "***BABY QUASA...
Medical Devices·7,734 affected·Oct 25, 2012
High RiskFDA
Philips Healthcare Inc.
Philips DigitalDiagnost X-Ray System with Eleva Software 2.1.3 Model numbers 712020, 712022, and 712082 Product Usage: Digital...
Diagnostic Devices·551 affected·Oct 25, 2012
High RiskFDA
Animas Corporation
Animas Vibe Insulin Infusion Pump and System. These products are indicated for continuous subcutaneous infusion of insulin for the tre...
Diabetes Devices·1,938 affected·Oct 25, 2012
High RiskFDA
Stryker Howmedica Osteonics Corp.
Hoffman LRF Wire Bolt, Catalog number 4933-1-001 through -003.
Medical Devices·476 affected·Oct 25, 2012
High RiskFDA
Quasar Bio-tech, Inc. Dba Silver Bay Llc
Quasar MD is an infrared LED lamp that is labeled in part: "***QUASAR MD***Bringing the Spa Home***Radiant and Youthful Skin***QUASAR MD ...
Medical Devices·7,734 affected·Oct 25, 2012
CriticalFDA
Verathon, Inc.
The GlideScope Video Laryngoscope (GVL) is a video laryngoscope that incorporates a high-resolution color camera, an LED light source, a ...
Medical Devices·2,710 affected·Oct 25, 2012
High RiskFDA
Carl Zeiss Meditec, Inc.
INTRABEAM Balloon Applicator Set; 3.5 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation ther...
Medical Devices·36 affected·Oct 25, 2012
CriticalFDA
Bumblebar, Inc.
Gluten Free Cafe Chocolate Sesame Bar. The Retail Carton has a UPC 70795-03450 and the Individual Bar has a UPC 70795-03550. The prod...
Snacks & Candy·1,219 affected·Oct 24, 2012
High RiskFDA
Dauphin Holdings, Inc. Dba Arnolds Candies
Arnold's Candies Handmade Since 1953 www.arnoldscandies.com Wintergreen Puffs***INGREDIENTS: Sugar, Cream of Tarter, Artificial Flavorin...
Dairy·100 affected·Oct 24, 2012
CriticalFDA
Bumblebar, Inc.
Gluten Free Cafe Cinnamon Sesame Bar. The Retail Carton has a UPC 70795-03451 and the Individual Bar has a UPC 70795-03551. The produ...
Food·1,323 affected·Oct 24, 2012
Medium RiskFDA
Glaxosmithkline, Llc.
Advair HFA (fluticasone propionate 45 mcg and salmeterol 21 mcg) Inhalation Aerosol, 12g, 120 Metered Actuations, For Oral Inhalation wit...
Oral Drugs·310,964 affected·Oct 24, 2012
RecallFDA
Glaxosmithkline, Llc.
Advair HFA (fluticasone propionate/salmeterol) Inhalation Aerosol, 45mcg/21 mcg 60 Actuations INST, NDC 0173-0715-22, Rx only, GlaxoSmit...
Drugs·18,676 affected·Oct 24, 2012
High RiskFDA
Superstat Corp
Superstat Modified Collagen Hemostatic Sponge, 32mm Disc, 3.0%, Part# 9100-30. For use when hemostasis is desired along suture lines, ...
Medical Devices·26,422 affected·Oct 24, 2012
High RiskFDA
Superstat Corp
Superstat Modified Collagen Hemostatic Sponge, 4x4 Pledget, 3.0%, Part# 9102-00. For use when hemostasis is desired along suture lines...
Medical Devices·26,422 affected·Oct 24, 2012
High RiskFDA
Superstat Corp
Superstat Modified Collagen Hemostatic Sponge, 85mm x 85mm Pledget, 1.5%, Part# 9300-15. For use when hemostasis is desired along sutu...
Medical Devices·26,422 affected·Oct 24, 2012
High RiskFDA
Superstat Corp
Superstat Modified Collagen Hemostatic Sponge, 2x2 Pledget, 1.5%, Part# 9105-00. For use when hemostasis is desired along suture lines...
Medical Devices·26,422 affected·Oct 24, 2012
High RiskFDA
Philips Medical Systems (cleveland) Inc
Philips Medical Systems, Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore, Model #728243; and Brilliance Computed Tomography ...
Medical Devices·765 affected·Oct 24, 2012
High RiskFDA
Superstat Corp
Superstat Modified Collagen Hemostatic Sponge, 50mm Disc, 3.0%, Part# 9200-30. For use when hemostasis is desired along suture lines, ...
Medical Devices·26,422 affected·Oct 24, 2012
High RiskFDA
Nidek Inc
Nidek MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic Device. The Nidek Multicolor Laser photocoagulator ...
Medical Devices·21 affected·Oct 24, 2012
High RiskFDA
Sekisui Diagnostics Llc
Sekisui Diagnostics, Spectrolyse PAI-1 In-Vitro Diagnostic Use for the quantitative determination of Plasminogen Activator Inhibitor Typ...
Diagnostic Devices·63 affected·Oct 24, 2012
High RiskFDA
Superstat Corp
Superstat Modified Collagen Hemostatic Sponge, 50mm Disc, 1.5%, Part# 9200-15. For use when hemostasis is desired along suture lines, ...
Medical Devices·26,422 affected·Oct 24, 2012
High RiskFDA
Philips Medical Systems (cleveland) Inc
Philips Medical Systems, Extended Brilliance Workspace (EBW) X-Ray Scanners, Model #728260. A component of the Computed Tomography X-Ray...
Medical Devices·39 affected·Oct 24, 2012
High RiskFDA
Superstat Corp
Superstat Modified Collagen Hemostatic Sponge, 50mm Disc, 3.0%, Part# 9200-30. For use when hemostasis is desired along suture lines, ...
Medical Devices·26,422 affected·Oct 24, 2012
High RiskFDA
Philips Medical Systems (cleveland) Inc
Philips Medical Systems, GEMINI TF Big Bore, Model #882476, Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scannin...
Diagnostic Devices·37 affected·Oct 24, 2012
High RiskFDA
Superstat Corp
Superstat Modified Collagen Hemostatic Sponge, 2x2 Pledget, 3.0%, Part# 9106-00. For use when hemostasis is desired along suture line...
Medical Devices·26,422 affected·Oct 24, 2012
High RiskFDA
The Dannon Company, Inc - Discovery & Innovation Center
Dannon Light & Fit Carb & Sugar Control Cultured Dairy Snack Vanilla Flavor 4x4oz cups
Dairy·662 affected·Oct 23, 2012
High RiskFDA
Unified Seafood Company., Inc.
Frozen Tuna Loins 3/5, 30lbs., UPC 8 29838 82310 7.
Seafood·1,333 affected·Oct 23, 2012
RecallFDA
Swanson Health Products, Inc
Swanson Organic, 100% Certified Organic Fennel Seed, Net Wt 6 oz (45 grams), SWF092, UPC 0 87614 24092 3.
Food·746 affected·Oct 23, 2012
RecallFDA
New B.c.n. Trading Inc
Asian Boy (EBQ) Tapioca Stick 3.5 oz (100g) New B.C.N. Trading Inc. 701 Hadky South Plainfield, NJ 07080 MINH NGUYET TRADING CO., LTD...
Food·71 affected·Oct 23, 2012
High RiskFDA
The Dannon Company, Inc - Discovery & Innovation Center
Dannon Activia LIGHT Nonfat Yogurt Peach Flavor 4x4oz cups INGREDIENTS: CULTURED GRADE A NONFAT MILK, WATER, PEACHES ***DISTRIBUTED BY: T...
Dairy·2,430 affected·Oct 23, 2012
High RiskFDA
The Dannon Company, Inc - Discovery & Innovation Center
Dannon Activia LIGHT Nonfat Yogurt Strawberry / Blueberry Flavor 12-4oz cups STRAWBERRY INGREDIENTS: CULTURED GRADE A NON FAT MILK, STRAW...
Dairy·4,494 affected·Oct 23, 2012
RecallFDA
Estee Lauder Inc
ESTEE LAUDER DayWear Sheer Tint Release, Advanced Multi-Protection Anti-Oxidant Moisturizer Broad Spectrum SPF15, All Skin types, 1.7 FL...
Drugs·1 affected·Oct 23, 2012
High RiskFDA
Stryker Howmedica Osteonics Corp.
Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #2.5 and Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #3.5, Howmedica Os...
Medical Devices·6,021 affected·Oct 23, 2012
High RiskFDA
Hospira Inc.
HEXTEND 6% Hetastarch in Lactated Electrolyte Injection, 500 mL, Rx only , MANUFACTURED AND DISTRIBUTED BY HOSPIRA, INC., LAKE FOREST, IL...
Injectable Drugs·11,412 affected·Oct 22, 2012
CriticalFDA
Zi Xiu Tang Success, Llc
Ultimate Formula, Net Wt. 250 mg, 48 capsules per bottle, Distributed by: Zi Xiu Tang Success, LLC., Trexlertown, PA 18087, UPC 7 93573...
Oral Drugs·16,126 affected·Oct 22, 2012
CriticalFDA
Zi Xiu Tang Success, Llc
Classic Zi Xiu Tang, Bee Pollen Capsule, Net Wt. 250 mg x 60 capsules per bottle, Distributed by: Zi Xiu Tang Success, LLC., Trexlertown...
Oral Drugs·6,084 affected·Oct 22, 2012
RecallFDA
Alere San Diego, Inc.
Alere Cholestech LDX Calibration Verification, 4 vial set, Catalog Number: 88770 Alere Cholestech LDX Calibration Verification (hereaf...
Diabetes Devices·614 affected·Oct 22, 2012
High RiskFDA
Becton Dickinson & Co.
BD BBL Taxo XV Factor Strips, Catalog number 231104, in shelf pack vials, fifty strips/vial labeled in part ***Becton, Dickinson and Comp...
Medical Devices·650 affected·Oct 22, 2012