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
Beekley Corporation
Beekley S-Spots Floral Skin Markers -Order Number: 750 Product Usage: Mammography Skin Markers for marking: moles, scars, palpable ma...
Medical Devices·36,518 affected·Jul 9, 2012
High RiskFDA
Beekley Corporation
Beekley A-Spots Floral Skin Markers -Order Number: 751 Product Usage: Mammography Skin Markers for marking: moles, scars, palpable ma...
Medical Devices·32,640 affected·Jul 9, 2012
High RiskFDA
Apheresis Technologies, Inc.
Plasma Pump Model PP-04a Used with Asahi Plasmaflo Plasma Separators and plasma exchange tubesets to perform therapeutic plasma exchange.
Medical Devices·13 affected·Jul 9, 2012
CriticalFDA
Arctic Zero, Inc.
Chocolate Peanut Butter, 1pt., UPC 8 52244 00301 5
Dairy·2,303,112 affected·Jul 6, 2012
CriticalFDA
Arctic Zero, Inc.
Pumpkin Spice, 1pt., UPC 8 52244 00307 7
Food·2,303,112 affected·Jul 6, 2012
CriticalFDA
Arctic Zero, Inc.
Vanilla Maple, 1pt., UPC 8 52244 00306 0
Food·2,303,112 affected·Jul 6, 2012
CriticalFDA
Arctic Zero, Inc.
Coffee, 1pt., UPC 8 52244 00302 2
Beverages·2,303,112 affected·Jul 6, 2012
CriticalFDA
Arctic Zero, Inc.
Chocolate, 1pt., UPC 8 52244 00300 8
Snacks & Candy·2,303,112 affected·Jul 6, 2012
CriticalFDA
Arctic Zero, Inc.
Chocolate Dipped Bars, 2 Chocolate & 2 Vanilla, 2.1 fl oz bars, UPC 8 52244 00308 4
Snacks & Candy·54,176 affected·Jul 6, 2012
CriticalFDA
Cass Clay Creamery Ampi Fargo Division
Peppermint Bon Bon Light Ice Cream under the following three brands: Hornbachers, Peppermint Bon Bon Light Ice Cream, Half Gallon (...
Dairy·2,492 affected·Jul 6, 2012
CriticalFDA
Arctic Zero, Inc.
Strawberry, 1pt., UPC 8 52244 00305 3
Produce·2,303,112 affected·Jul 6, 2012
RecallFDA
Vintage Pharmaceuticals Llc Dba Qualitest Pharmaceuticals
HYDROXYZINE HYDROCHLORIDE ORAL SOLUTION, USP, 10 mg/5 mL, 1 PINT (473 mL) bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVIL...
Oral Drugs·73,746 affected·Jul 6, 2012
High RiskFDA
Glenmark Generics Inc., Usa
NAPROXEN TABLETS USP, 500 mg, 100-count Tablets per bottle, Rx only, Manufactured by: Glenmark Generics Ltd., Colvale-Bardez, Goa 403513,...
Oral Drugs·0 affected·Jul 6, 2012
RecallFDA
Vintage Pharmaceuticals Llc Dba Qualitest Pharmaceuticals
HYDROCORTISONE and ACETIC ACID OTIC SOLUTION, USP, 10 mL bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811; NDC...
Drugs·54,431 affected·Jul 6, 2012
High RiskFDA
Fms, Finapres Medical Systems Bv
Finapres Medical Systems Portapres with NiMh battery pack Product Usage: Continuously measure blood pressure, The Portapres can be ...
Medical Devices·3 affected·Jul 6, 2012
High RiskFDA
Linvatec Corp. Dba Conmed Linvatec
PopLok Punch labeled in part: "PKL-35M***3.5mm***QTY 1***PopLok Punch***ConMed Linvatec Biomaterials, Ltd. Hermiankatu 6-8L 33720 Tamper...
Medical Devices·2 affected·Jul 6, 2012
High RiskFDA
Cafe Moto
Flavored coffee. Cafe Moto Almond Truffle Flavored Coffee, 16 oz.
Beverages·0 affected·Jul 5, 2012
High RiskFDA
Southwind Foods Llc Dba Great American Seafood Imports Co.
Great American Seafood Imports Co. Cooked Shrimp Meat. Size: 300/500 count per pound in 2-lb (item #06834) and 5-lb (Item #07756) packages.
Meat & Poultry·150 affected·Jul 5, 2012
High RiskFDA
Ben Venue Laboratories Inc
Leucovorin Calcium Injection USP, single use vials, 10mg/mL; 50mL, Rx only, Manufactured by: Ben Venue Labs, Inc., Bedford, OH 44146, NDC...
Injectable Drugs·226,010 affected·Jul 5, 2012
CriticalFDA
Synthes Usa Hq, Inc.
Synthes(R) Hemostatic Bone Putty, Part numbers 08.901.001.97S, 08.901.001.98S, 08.901.001.99S, 08.901.001D, and VB1025.10S. Indicated ...
Medical Implants·8,853 affected·Jul 5, 2012
High RiskFDA
Kimberly-clark Corporation
MicroCool Breathable Gown with Towels, X-Larg, X-Long, Sterile The product is a sterile, single use, surgical gown intended to protect...
Surgical Devices·933 affected·Jul 5, 2012
High RiskFDA
Radiometer America Inc
ABL90 FLEX software version 2.7 MR3. The ABL90 FLEX analyzer is intended for in vitro testing of samples of heparinized whole blood.
Medical Devices·1,427 affected·Jul 5, 2012
High RiskFDA
Radiometer America Inc
The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of w...
Medical Devices·6,854 affected·Jul 5, 2012
High RiskFDA
Kimberly-clark Corporation
ULTRA Fabric Reinforced surgical Gown X-Large Sterile The product is a sterile, single use, surgical gown intended to protect surgical...
Surgical Devices·89,856 affected·Jul 5, 2012
CriticalFDA
Pacific International Marketing
Romaine Lettuce tied with a rubber band
Produce·945 affected·Jul 3, 2012
High RiskFDA
Andante Dairy
Multiple lots of cheese produced by Andante Dairy, Petaluma, CA; Sold in 5 oz to 8 oz sizes with no code date or variety information on p...
Dairy·3,870 affected·Jul 3, 2012
CriticalFDA
Fruiti Pops Inc.
Fruiti Pops Coconut Ice Bars, 4 oz. Product labeling reads in part:" Fresh fruit bar Fruiti Pops Classic Coconut 4 FL OZ (118mL)***FRUITI...
Produce·178 affected·Jul 3, 2012
High RiskFDA
Opti Medical Systems, Inc
BP7561 OPTI CCA-TS B-Lac Cassette (25 per box) Cassettes are consumables used in the OPTI CCA-TS Analyzer intended to be used for in v...
Respiratory Devices·895 affected·Jul 3, 2012
High RiskFDA
Chicago X-ray Systems, Inc.
Fona Srl IntraOs 70 intra-oral x-ray system IntraOS 70 is an extra oral source X-ray system for dental radiographic examination and di...
Medical Devices·1,960 affected·Jul 3, 2012
High RiskFDA
Stryker Howmedica Osteonics Corp.
Hoffman LRF Telescopic Strut Short Stryker Stryker Trauma AG CH-2545 Seizach Distributed in the USA by Howmedica Osteonics Corp. 3...
Medical Devices·165 affected·Jul 3, 2012
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with three #2 sutures (white, COBRAID- blue), sterile Part Number: 72202897 Product Usa...
Medical Devices·4,411 affected·Jul 3, 2012
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures(white, COBRAID-blue), sterile Part Number: 72202895 Product Usage: ...
Medical Devices·4,661 affected·Jul 3, 2012
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures (COBRAID-blue, COBRAIDblack), sterile Part Number: 72202896 Product...
Medical Devices·2,204 affected·Jul 3, 2012
RecallFDA
Nha Trang Seafoods, Inc
Frozen Pangasius Fish, brand name T&T, in the following sizes: a. IQF 15 lbs bulk carton: 3/5 oz, 5/7 oz, 7/9 oz, 9/11 oz b. 11lbs x...
Seafood·2,529 affected·Jul 2, 2012
RecallFDA
Hospira Inc.
Carboplatin Injection, 10 mg/mL, a) 5 mL multi-dose vials (NDC 61703-339-18) (NDC 61703-360-18, NOVAPLUS), b) 45 mL multi-dose vials (ND...
Injectable Drugs·77,542 affected·Jul 2, 2012
RecallFDA
Astra Zeneca Lp
Nexium (esomeprazole magnesium) Delayed-Release Capsules, 40 mg, 1000-count bottle, Rx only, Manufactured for: AstraZeneca LP, Wilmington...
Oral Drugs·2,556 affected·Jul 2, 2012
High RiskFDA
Greiner Bio-one North America, Inc.
3mL 9NC Coagulation Sodium Citrate 3.2%, Item #454334, Greiner Bio-One North America Inc., 4238 Capital Drive, Monroe, NC 28110. Inte...
Medical Devices·838 affected·Jul 2, 2012
High RiskFDA
Ethicon, Inc.
EVICEL Fibrin Sealant (Human) Rx Only. Manufacturer: Omrix Biopharmaceuticals Ltd. MDA blood bank, Sheba Hospital, Ramat-Gan, POB 8...
Medical Devices·4,800 affected·Jul 2, 2012
High RiskFDA
Philips Medical Systems (cleveland) Inc
Philips Brilliance 6, 16, 40, 64, Big Bore, iCT and iCT SP are Computed Tomography X-Ray Systems. The devices are Computed Tomography ...
Medical Devices·524 affected·Jul 2, 2012
High RiskFDA
Merge Healthcare, Inc.
Merge HEMO software.
Medical Devices·37 affected·Jul 2, 2012
High RiskFDA
Beekley Corporation
Bella Blanket Protective Coverlet, for Mammography, 18cm x 25cm or 24cm x 30cm, Product Code: 311. The purpose of the product is to remo...
Medical Devices·86,000 affected·Jul 2, 2012
High RiskFDA
Draeger Medical Systems, Inc.
Drager PT 4000 Phototherapy System
Medical Devices·65 affected·Jul 2, 2012
High RiskFDA
Designer Protein Llc
Designer Whey Chocolate, 2lbs, item#10200131, 4 units/case. UPC 8-44334-00131-5.
Snacks & Candy·6,366 affected·Jun 29, 2012
RecallFDA
Itoen (usa) Inc
Aloha Maid Natural brand Coconut Water with Pineapple in 11.5 fl oz (340mL) Can; UPC Code: 8-35146-00818-3; 24 cans per case (4 packs X 6...
Beverages·8,340 affected·Jun 29, 2012
High RiskFDA
Lovin Oven, Llc
Earth's Best Organic Wheat Teething Biscuits, 6 pack, UPC # 23923-90015, HCG#C90615
Food·8,904 affected·Jun 29, 2012
High RiskFDA
Designer Protein Llc
Designer Whey Strawberry, 2lbs, Item#10200137, 4 units/case. UPC 8-44334-00137-7.
Produce·6,366 affected·Jun 29, 2012
High RiskFDA
21st Century Foods, Inc.
21st Century Foods Soy Tempeh, packaged in 12 lb plastic bags and 8 oz containers
Food·30 affected·Jun 29, 2012
CriticalFDA
Dole Fresh Vegetables Inc
Dole brand Hearts of Romaine; Net Wt. 10 oz. UPC 71430 00956; Dole
Food·2,598 affected·Jun 29, 2012