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
CriticalFDA
Golden Star International Inc.
BON APPETITO WALNUT LADIES FINGER, Net Wt.: 10oz. (340g), UPC 6 44744 69876 7
Food48 affectedNov 1, 2016
RecallFDA
Teva Pharmaceuticals Usa
Qnasl (beclomethasone dipropionate) Nasal Aerosol 40 Mcg, 60 Metered Sprays, Rx only, Manufactured for Teva Respiratory, LLC, Horsham, PA...
Inhaled / Nasal Drugs201 affectedNov 1, 2016
High RiskFDA
Hospira Inc.
Fentanyl Citrate Injection, USP, 100 mcg Fentanyl/ 2mL, Single Dose, 50 mcg/mL, Rx only, Hospira, Inc., Lake Forest IL 60045, NDC 0409-40...
Injectable Drugs797,800 affectedNov 1, 2016
RecallFDA
Teva Pharmaceuticals Usa
Qnasl (beclomethasone dipropionate) Nasal Aerosol 80 Mcg, 50 Metered Sprays, Rx only, Manufactured for Teva Respiratory, LLC, Horsham, PA...
Inhaled / Nasal Drugs0 affectedNov 1, 2016
High RiskFDA
Synthes (usa) Products Llc
Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm Stop/44.5 mm Non-Sterile
Medical Devices84 affectedNov 1, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Q, Angiographic x-ray system Product Usage: The Artis systems are a family of dedicated angiography systems developed for singl...
Cardiac Devices4,657 affectedNov 1, 2016
High RiskFDA
Carefusion 303, Inc.
Alaris System PC unit, model no. 8000 and 8015. The central programming, monitoring and power supply component for the Alaris infusion p...
Medical Devices613,800 affectedNov 1, 2016
High RiskFDA
Mevion Medical Systems, Inc.
MEVION S250 Product Usage: Proton Radiation Therapy
Medical Devices6 affectedOct 31, 2016
High RiskFDA
Sorin Group Usa, Inc.
Perceval Sutureless Aortic Heart Valve size S, Item # ICV1208, REF PVS21; Perceval Sutureless Aortic Heart Valve size M, Item # ICV1209, ...
Medical Implants845 affectedOct 31, 2016
High RiskFDA
Roche Diagnostics Operations, Inc.
MSS CASSETTE GLU/LAC/UREA (BUN) as a part of the Roche OMNI S Analyzer: cobas b 221<6>Roche OMNI S6 system The Roche Diagnostics Omni S...
Diabetes Devices97 affectedOct 31, 2016
High RiskFDA
Spectranetics Corporation
Bridge Occlusion Balloon. Model: 590-001 Temporary vessel occlusion of the superior vena cava in applications including perioperative oc...
Medical Devices873 affectedOct 31, 2016
High RiskFDA
Synthes (usa) Products Llc
Synthes Flexible Shaft, Orthopedic manual surgical instrument The Flexible shafts are intended for use as an optional reaming step in ...
Surgical Devices198 affectedOct 31, 2016
RecallFDA
Smiths Medical Asd, Inc.
HOTLINE Blood and Fluid Warmer, Mole l HL-90. Designed for use with the Hotline Fluid Warming Set (L-80, L-70 and L-70N) to warm blood a...
Medical Devices33 affectedOct 31, 2016
High RiskFDA
Spectranetics Corporation
Turbo Elite Atherectomy Catheter. Models: 410-152, 410-154, 414-151, 414-159, 417-152, 417-156, 420-006, 420-159, 423-001, 423-135-01 Th...
Surgical Devices14,624 affectedOct 31, 2016
High RiskFDA
Owens & Minor Distribution, Inc.
Medi Choice Arm Slings ASL 2103 Small 7.5 x 12.5 Inch 1/EA, 24 ENCA ASL 2104 Medium 8 x 15 Inch 1/EA, 24 ENCA ASL 2105 Large 8.5 x 1...
Medical Devices568 affectedOct 31, 2016
CriticalFDA
Life Rising Corp S
Life Rising TT Side Head Regulator, Chinese Herbal Supplement, 60 Tablets; Manufactured for: Ton Shen Health (USA), Chicago, IL, 60616; M...
Supplements6,964 affectedOct 28, 2016
RecallFDA
Conifer Specialties, Inc.
Simply Balanced brand White Chicken Chili dry soup mix. This is not a ready to eat product and it does not contain any chicken. It is p...
Meat & Poultry1,494 affectedOct 28, 2016
High RiskFDA
Aldi Inc
Simply Nature Organic Red Split Lentils, 16 oz bag, UPC 041498299507
Food73,920 affectedOct 28, 2016
High RiskFDA
Aldi Inc
Simply Nature Organic Green Lentils, 16 oz bag, UPC 041498299514
Food73,920 affectedOct 28, 2016
CriticalFDA
Mondelez International
Nabisco Oreo Fudge Creme Mint Variety, Net Wt. 11.3 oz Distributed by: Mondelez Global LLC East Hanover, NJ UPC 044000026967
Food0 affectedOct 28, 2016
CriticalFDA
Mondelez International
Nabisco Oreo Fudge Creme Original Variety, Net Wt. 11.3 oz Distributed by: Mondelez Global LLC East Hanover, NJ UPC 044000026943
Food0 affectedOct 28, 2016
High RiskFDA
Nationwide Laboratories, Llc
Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, Ne...
Oral Drugs5,786,653 affectedOct 28, 2016
CriticalFDA
Love My Tru Body
Skinny Bee Diet capsules, 500 mg, packaged in a 60-count bottle
Oral Drugs74 affectedOct 28, 2016
Medium RiskFDA
Sun Pharmaceutical Industries, Inc.
KENALOG (Triamcinolone Acetonide) Spray with Spray Tube Topical Aerosol, USP, (0.147 mg/g), 15 g bottle, Physician Sample: Not For Sale, ...
Topical Drugs326,103 affectedOct 28, 2016
High RiskFDA
Nationwide Laboratories, Llc
Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, Ne...
Oral Drugs6,333,669 affectedOct 28, 2016
High RiskFDA
Nationwide Laboratories, Llc
Salsalate Tablets, USP, 500 mg, packaged in a) 500 count bottles (NDC 42937-703-18); b) 100 count bottles (NDC 42937-703-10); and c) 1000...
Oral Drugs2,882,661 affectedOct 28, 2016
High RiskFDA
Nationwide Laboratories, Llc
Salsalate Tablets, USP, 750 mg, packaged in a) 100 count bottles (NDC 42937-704-10); b) 500 count bottles (NDC 42937-704-18); and c) 1000...
Oral Drugs2,514,500 affectedOct 28, 2016
High RiskFDA
Natus Medical Incorporated
Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 00622...
Medical Devices2,619 affectedOct 28, 2016
High RiskFDA
Integra York Pa, Inc
Rochester-Pean Hemostatic Forceps 61/4, Curved, Sterile. The Rochester-Pean Hemostatic Forceps 61/4 Curved are single-use sterile surg...
Surgical Devices150 affectedOct 28, 2016
High RiskFDA
Integra York Pa, Inc
Metzenbaum Scissors 7, Curved, Sterile The Metzenbaum Scissors 7, Curved Curved are single-use sterile surgical instruments intended...
Surgical Devices50 affectedOct 28, 2016
CriticalFDA
Back To Nature Foods, Llc
Back to Nature Mini Chocolate Chunk Cookies, 6 - 1.25oz (35g) UPC 8-19898-01114-8 (tray) and UPC 8-19898-01115-5 (pouch); 100 - 1.25oz (...
Bakery & Grains7,982 affectedOct 27, 2016
CriticalFDA
Back To Nature Foods, Llc
Back to Nature, Gluten Free, Dark Chocolate Coconut Granola, 11 oz (311g) pouches, 6 pouches per case. UPC 8-19898-01225-8.
Bakery & Grains5,448 affectedOct 27, 2016
CriticalFDA
Back To Nature Foods, Llc
Back to Nature Chocolate Chunk Cookies, 9.5 oz (269g) . pouches, 6 pouches per case. UPC 8-19898-01100-1.
Bakery & Grains26,021 affectedOct 27, 2016
CriticalFDA
Back To Nature Foods, Llc
Back to Nature, Gluten-Free, Chocolate Delight Granola, 11 oz.(311g) pouches, 6 per case. UPC 8-19898-01201-5.
Bakery & Grains79,098 affectedOct 27, 2016
RecallFDA
Amerisource Health Services
Bupropion Hydrochloride Extended-Release Tablets, USP (XL), 300 mg, a) 90-count bottle (NDC 68001-264-05), b) 500-count bottle (NDC 680...
Oral Drugs15,409 affectedOct 27, 2016
High RiskFDA
Teleflex Medical
Mucosal Atomization Device (MAD), Intranasal Mucosal Atomization Device with 3mL Syringe and Vial Adapter; Product Code MAD100, MAD100OS ...
Medical Devices2,674,650 affectedOct 27, 2016
High RiskFDA
Teleflex Medical
LMA MADomizer, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the o...
Medical Devices2,674,650 affectedOct 27, 2016
High RiskFDA
Teleflex Medical
LMA MADdy, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral,...
Medical Devices2,674,650 affectedOct 27, 2016
High RiskFDA
Teleflex Medical
LMA MADett, Endotracheal tube Mucosal Atomization Device, Rx only, Product Usage: These products are used for the delivery of topica...
Medical Devices2,674,650 affectedOct 27, 2016
High RiskFDA
Brainlab Ag
Femoral and Tibial Cutting Block Adapter Base. Brainlab knee, BrainLAB Image Guided Surgery System / Instrument, Stereotaxic
Medical Devices29 affectedOct 27, 2016
CriticalFDA
Leo Leo Gelato
Raspberry Sorbet, 5 Liter & 4 Liter pans
Produce1,031 affectedOct 26, 2016
CriticalFDA
Leo Leo Gelato
Strawberry Nutella gelato, 5 Liter & 4 Liter pans
Produce1,031 affectedOct 26, 2016
CriticalFDA
Leo Leo Gelato
Strawberry Sorbet, 5 Liter & 4 Liter pans
Produce1,031 affectedOct 26, 2016
High RiskFDA
Pastian's Bakery
French Baguette Bread. 9.5 oz. Clear Plastic Bag. 1 loaf
Bakery & Grains2 affectedOct 26, 2016
High RiskFDA
Pastian's Bakery
Homestyle Texas Toast. 1 lb. 8 oz. Clear Plastic Bag. 1 loaf
Food121 affectedOct 26, 2016
CriticalFDA
Dfi Organics
100% Org. Sesame Seeds natural, 50 LBS, Product of Uganda The sesame seeds are packed in multi ply paper bags.
Food4,200 affectedOct 26, 2016
High RiskFDA
Pastian's Bakery
Texas Toast. 1 lb. 8 oz. Clear Plastic Bag. 1 loaf
Food49 affectedOct 26, 2016
CriticalFDA
Leo Leo Gelato
Mixed Berries gelato, 5 Liter & 4 Liter pans
Produce1,031 affectedOct 26, 2016