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
St. Jude Medical, Inc.
Infinity 5 Implantable Pulse Generator and Infinity 7 Implantable Pulse Generator Models 6660, 6661, 6662, 6663
Medical Implants·3,119 affected·Sep 12, 2017
High RiskFDA
Zoll Manufacturing Corp.
LifeVest Wearable Defibrillator Model 4000, Product Number 10A0988-A01. The LifeVest system is indicated for patients 18 years of age ...
Medical Implants·33,670 affected·Sep 12, 2017
High RiskFDA
Otto Bock Healthcare Product
OTTO BOCK Kenevo knee joints Model 3C60=ST
Medical Devices·4 affected·Sep 12, 2017
High RiskFDA
Terumo Medical Corporation
Destination Guiding Sheath catheter introducer, Catalog Number: RSR06 Product Usage: The Destination¿ Guiding Sheath is designed to b...
Surgical Devices·33 affected·Sep 12, 2017
High RiskFDA
Otto Bock Healthcare Product
OTTO BOCK Kenevo knee joints Model 3C60
Medical Devices·75 affected·Sep 12, 2017
High RiskFDA
Diversified Foods And Seasonings, Inc
Homestyle Broccoli and Cheese Soup, 1.66 lb Plastic boil-n-bag pouches, frozen, Contains: Milk, Soy, Wheat
Dairy·147 affected·Sep 11, 2017
High RiskFDA
United Therapeutics Corp.
TYVASO (treprostinil) Inhalation Solution Treprostinil 1.74 mg/2.9 mL (0.6 mg/mL) Tyvaso Inhalation System Starter Kit Model# TD-100/A, R...
Drugs·12 affected·Sep 11, 2017
High RiskFDA
Medtronic Inc.
Medtronic MiniMed(TM) Pro-set(TM) (MMT-280, 281)
Medical Devices·5,842 affected·Sep 10, 2017
High RiskFDA
Apple King, Llc
Fuji apples, Nature's Delight brand, packaged in tray pack box size 64, net weight 40 lbs., PLU 4131, distributed by L&M Yakima, WA 98903
Food·11,801 affected·Sep 8, 2017
CriticalFDA
Simply Fresh Foods Inc
San Francisco Foods Seafood Salad; Deli Style Seafood Salad with Greek Yogurt; 4 x 4 oz. (113 g) cups  Net Wt. 16 oz. (1 LB) 454 g; ...
Dairy·272 affected·Sep 8, 2017
CriticalFDA
Bravo Produce Inc
Maradol Papaya; Frutas Selectas De Tijuana, S. DE R.L. DE, C.V. Sold in 14.00 kg/ 31 Lb. cardboard boxes.
Food·8,325 affected·Sep 8, 2017
RecallFDA
Abbvie Inc.
AndroGel (testosterone gel) 1.62%, 40.5mg in 2.5g aluminum foil packet, 30 Packets per carton. Rx Only. Marketed by: AbbVie Inc., North...
Topical Drugs·48 affected·Sep 8, 2017
RecallFDA
Abbvie Inc.
AndroGel (testosterone gel) 1.62%, 88 gm metered-dose pump, 20.25 mg of testosterone per pump actuation, 60 metered pump actuations, Rx O...
Topical Drugs·520 affected·Sep 8, 2017
High RiskFDA
Howmedica Osteonics Corp.
AccuLIF TL Insertion Handle The AccuLIF Insertion Handle attaches to the implant and is specifically designed to allow a surgeon to i...
Medical Implants·130 affected·Sep 8, 2017
High RiskFDA
Handicare Usa Inc
PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered
Medical Devices·8 affected·Sep 8, 2017
High RiskFDA
Limacorporate S.p.a
Delta Cup Beater  Positioner - Aligner, model # 9057.20.555 Used during implantation of the Delta Acetabular System
Medical Implants·20 affected·Sep 8, 2017
High RiskFDA
Sysmex America, Inc.
Sysmex Fluorocell(R) PLT Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platelets with the Sys...
Medical Devices·23,239 affected·Sep 8, 2017
CriticalFDA
Good Eggs Sf - Bay
Panang Curry included in the Beef Panang Curry Dinner, 3.5 oz. 8oz plastic deli container bearing the name Curry Paste. Ingredients: ...
Meat & Poultry·547 affected·Sep 7, 2017
CriticalFDA
Garden Of Life, Llc
Garden of Life, Baby Organic Liquid probiotic formula, 56 ml (1.9 fl oz)
Baby Food & Formula·8,475 affected·Sep 7, 2017
High RiskFDA
Radiometer America Inc
AutoCheck5+, Level 2, specifically designed for Radiometer Americas blood gas analyzers The QUALICHECK+ quality control (QC) ampoules a...
Medical Devices·1,669 affected·Sep 7, 2017
High RiskFDA
Coborn's, Inc
Coborn's/Cash Wise Caraway Rye Bread - UPC 7-33147-20155-8 Net Wt. 16 oz (1.0 lb) (454 g) Sell by 9/6/2017
Bakery & Grains·121 affected·Sep 6, 2017
High RiskFDA
Coborn's, Inc
Coborn's/Cash Wise American Rye Bread - UPC 7-33147-20150 Net Wt. 16 oz (1.0 lb) (454 kg) Sell by 9/7/2017
Bakery & Grains·121 affected·Sep 6, 2017
High RiskFDA
Biosense Webster, Inc.
THERMOCOOL SF NAV Catheters Model Numbers - BNI35FJCT, BNI35DFCT, D-131503-S, D-131504-S
Surgical Devices·329 affected·Sep 6, 2017
High RiskFDA
Biosense Webster, Inc.
THERMOCOOL SMARTTOUCH SF Uni-Directional Product Codes D-1347-01-S, D-1347-02-S, D-1347-03-S
Medical Devices·357 affected·Sep 6, 2017
High RiskFDA
Wegmans Food Markets, Inc.
Wegmans Assorted Muffins 4-Pack-18 oz. (1 lb. 2 oz.) 510g packaged in clear plastic shell. UPC: 77890-22744 .
Food·0 affected·Sep 5, 2017
High RiskFDA
Now Foods
Organic Coconut Sugar, 16oz bag, 12 bags/case, packed in a foil bag
Food·12,401 affected·Sep 5, 2017
RecallFDA
Aidarex Pharmaceuticals Llc
Phentermine, USP Capsules, 15 mg, 30 count bottles, Rx only, Packaged By: Aidarex Pharmaceuticals, Corona, CA, MFG: KVK-TECH INC. Newtown...
Oral Drugs·35 affected·Sep 5, 2017
High RiskFDA
Medex Cardio-pulmonary Inc., D.b.a. Smiths Medical Company
Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 4 oz. 24 units per box. Manufactured by Medex Cardio-Pulmonary Inc...
Drugs·22,080 affected·Sep 5, 2017
High RiskFDA
Medex Cardio-pulmonary Inc., D.b.a. Smiths Medical Company
Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 32 oz. 12 units per box. Manufactured by Medex Cardio-Pulmonary In...
Drugs·96,828 affected·Sep 5, 2017
High RiskFDA
Teva Pharmaceuticals Usa
Acarbose Tablets, 25 mg, 100-count bottle, Rx only, Manufactured by: Arrow Pharm (Malta) Ltd., Birzebbugia BBG3000, Malta; Distributed by...
Oral Drugs·3,275 affected·Sep 5, 2017
High RiskFDA
Medex Cardio-pulmonary Inc., D.b.a. Smiths Medical Company
Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 16 oz. 12 units per box. Manufactured by Medex Cardio-Pulmonary In...
Drugs·130,740 affected·Sep 5, 2017
CriticalFDA
Genentech, Inc.
Activase (alteplase), 100 mg (58 million IU), Lyophilized vial, packaged with 1 single-dose 100ml vial of sterile water for Injection USP...
Injectable Drugs·16,882 affected·Sep 5, 2017
High RiskFDA
Simple Diagnostics, Inc.
Alcohol Prep Pads (Isopropyl Alcohol USP 70% v/v), 100 Individual Pads, Sterile, Distributed by Simple Diagnostics, Winston Park, NY NDC...
Drugs·150,250 affected·Sep 5, 2017
High RiskFDA
Medex Cardio-pulmonary Inc., D.b.a. Smiths Medical Company
Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 1 oz. 144 units per box. Manufactured by Medex Cardio-Pulmonary In...
Drugs·29,232 affected·Sep 5, 2017
RecallFDA
Aidarex Pharmaceuticals Llc
ENALAPRIL MALEATE Tablets, USP, 5MG, 90-count bottles, Rx only, MFG: Wockhardt Ltd., India; Packaged By: Aidarex Pharmaceuticals; NDC 332...
Oral Drugs·12 affected·Sep 5, 2017
High RiskFDA
Llorens Pharmaceutical Corp.
Urin D/S Tablets Methenamine 81.6 mg, Sodium Biphosphate 40.8 mg, Phenyl Salicylate 36.2 mg, Methylene Blue 10.8 mg, Hyoscyamine Sulfate ...
Oral Drugs·19,232 affected·Sep 5, 2017
High RiskFDA
Aesculap Implant Systems Llc
ELAN 4 Blade: ELAN 4 1-RING PIN CUTTER D1.0 ELAN 4 1-RING NEURO CUTTER+ SOFT D1.5 ELAN 4 1-RING NEURO CUTTER+ SOFT D2.0 ELAN 4 1-RING ...
Medical Devices·6,211 affected·Sep 5, 2017
CriticalFDA
Medex Cardio-pulmonary Inc., D.b.a. Smiths Medical Company
Portex 5ml Normal Saline (0.9%) Unit Dose¿¿¿¿ ¿
Medical Devices·106,000 affected·Sep 5, 2017
CriticalFDA
Medex Cardio-pulmonary Inc., D.b.a. Smiths Medical Company
Portex 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿¿ ¿¿¿ ¿¿¿
Medical Devices·11,508 affected·Sep 5, 2017
High RiskFDA
Aesculap Implant Systems Llc
ELAN 4 Burr: ELAN 4 1-RING ROSEN BURR+ D0.6 ELAN 4 1-RING ROSEN BURR+ D0.8 ELAN 4 1-RING ROSEN BURR D1.0 ELAN 4 1-RING ROSEN BURR TC D...
Medical Devices·10,984 affected·Sep 5, 2017
CriticalFDA
Medex Cardio-pulmonary Inc., D.b.a. Smiths Medical Company
Medline Prefilled 350 ml Sterile¿¿¿¿ ¿¿¿¿ ¿
Medical Devices·235,560 affected·Sep 5, 2017
CriticalFDA
Medex Cardio-pulmonary Inc., D.b.a. Smiths Medical Company
Intermed 350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿ ¿¿¿
Medical Devices·128,000 affected·Sep 5, 2017
CriticalFDA
Medex Cardio-pulmonary Inc., D.b.a. Smiths Medical Company
Medline 300-350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿
Medical Devices·16,380 affected·Sep 5, 2017
CriticalFDA
Medex Cardio-pulmonary Inc., D.b.a. Smiths Medical Company
Portex Unit Dose 5 ml Normal Saline (0.9%)¿¿¿¿ ¿
Medical Devices·102,000 affected·Sep 5, 2017
CriticalFDA
Medex Cardio-pulmonary Inc., D.b.a. Smiths Medical Company
Portex Unit Dose 15 ml Normal Saline ¿
Medical Devices·357,552 affected·Sep 5, 2017
CriticalFDA
Medex Cardio-pulmonary Inc., D.b.a. Smiths Medical Company
Medline Prefilled 550 ml Sterile¿¿ ¿
Medical Devices·54,924 affected·Sep 5, 2017
CriticalFDA
Country Fresh Products, Llc
Tri-Pepper Dice, 6-oz. packaged in a clamshell and Dice Tri-Pepper, 7-oz. packaged in a clamshell
Food·0 affected·Sep 2, 2017
CriticalFDA
Country Fresh Products, Llc
Vegetable Kabob, 23-oz. packaged in an overwrap; Kabob Sensations Veggie Kabob, 15-oz. packaged in am overwrap; Marketside Veggie Kabobs,...
Produce·0 affected·Sep 2, 2017