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
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68,659 recalls
High RiskFDA
Siemens Medical Solutions Usa, Inc.
Symbia Intevo 6, SPECT/CT System, Emission Computed Tomography System To detect or image the distribution of radionuclides in the body o...
Medical Devices·2 affected·Nov 7, 2017
High RiskFDA
Pacific Rim Distribution Inc.
Bean Boy Coffee Dark Chocolate Covered Espresso Beans
Snacks & Candy·1,064 affected·Nov 6, 2017
RecallFDA
West-ward Pharmaceuticals Corp.
Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, 1 mL Vials (NDC 0641-6145-01), packaged in 25 x 1 mL Vials per shelf pack (NDC 06...
Injectable Drugs·16,157 affected·Nov 6, 2017
RecallFDA
Claris Lifesciences Inc
Ciprofloxacin in Dextrose (5%) Injection, USP 200 mg in 100 mL 5% Dextrose, Rx Only, (2 mg/mL), 100 mL Flexible Bag, Manufactured for: C...
Injectable Drugs·0 affected·Nov 6, 2017
RecallFDA
West-ward Pharmaceuticals Corp.
Dexamethasone Sodium Phosphate Injection, USP, 20 mg/5 mL (4 mg/mL), 5 mL Vials (NDC 0641-6146-01), packaged in 25 x 5 mL Vials per shelf...
Injectable Drugs·1,896 affected·Nov 6, 2017
High RiskFDA
Owen Mumford Usa, Inc.
Unifine Pentips 5mm x 31G pen needles, packaged in 100 ct pen needles. Product Usage: Sterile, non-toxic, non-pyrogenic, single use p...
Medical Devices·2,660 affected·Nov 6, 2017
CriticalFDA
Beckman Coulter Inc.
Access 2 Immunoassay System, Catalog Number 81600N. In vitro diagnostic device used for the quantitative, semi-quantitative, or qualit...
Diagnostic Devices·227 affected·Nov 6, 2017
High RiskFDA
Owen Mumford Usa, Inc.
Unifine Pentips 5mm x 31G pen needles, packaged in 30 ct pen needles. Product Usage: Sterile, non-toxic, non-pyrogenic, single use p...
Medical Devices·708 affected·Nov 6, 2017
High RiskFDA
Carefusion 303, Inc.
Alaris Extension Sets with microbore tubing Model 20022 and 30914 Is used to administer fluid and medications from a syringe to the p...
Surgical Devices·25,400 affected·Nov 6, 2017
High RiskFDA
Boston Scientific Corporation
Innova Self-Expanding Stent System, 200 mm. Labeled with Material Number and description as follows: Product Usage: The Innova Vascu...
Medical Implants·22,916 affected·Nov 6, 2017
CriticalFDA
Beckman Coulter Inc.
UniCel DxC 600i SYNCHRON Access Clinical Systems; A25656, A25638. In vitro diagnostic device used for the quantitative, semi-quantitat...
Diagnostic Devices·2 affected·Nov 6, 2017
High RiskFDA
Southmedic, Inc.
Southmedic Sterile Disposable Scalpel Rx only Scalpels are intended to be used in various medical procedures for preparation, scraping...
Surgical Devices·3,300 affected·Nov 6, 2017
High RiskFDA
Gourmet Nut, Inc.
GourmetNut DARK CHOCOLATE COVERED ALMONDS NET WT 7oz (198g); UPC: 708747152203
Snacks & Candy·5,640 affected·Nov 3, 2017
High RiskFDA
Ridge Properties, Llc
Extra Strength Naturally HL Liquid Hemorrhoid Relief Gel, (lidocaine HCL 4%), 1/2 oz Liquid Gel (NDC 69804-024-13), 1 oz Liquid Gel (NDC...
Topical Drugs·0 affected·Nov 3, 2017
High RiskFDA
Ridge Properties, Llc
Extra Strength Naturally HL Bed Sore Relief Cream with Added Lidocaine, (lidocaine HCL 4%), 1/2 oz Balm(NDC 69804-008-06), 1 oz Balm (NDC...
Topical Drugs·0 affected·Nov 3, 2017
High RiskFDA
Ridge Properties, Llc
Extra Strength Naturally HL Hemorrhoid Numbing with Lidocaine, (lidocaine HCL 4%), 1/2 oz Balm (NDC 69804-014-06), and 2 oz Balm(NDC 6980...
Drugs·0 affected·Nov 3, 2017
High RiskFDA
Ridge Properties, Llc
Extra Strength PreTAT by TAT BALM Gel, (lidocaine HCL 4%), 1/2 oz Gel (NDC 69804-018-09), 1 oz Gel (NDC 69804-018-10) , 2 oz Gel (NDC 698...
Topical Drugs·0 affected·Nov 3, 2017
RecallFDA
Mylan Pharmaceuticals Inc.
bupPROPion HCL Extended-Release Tablets, USP (XL) 300 mg, 500-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S....
Oral Drugs·1,414 affected·Nov 3, 2017
High RiskFDA
Ridge Properties, Llc
Extra Strength Naturally HL Hemorrhoid Numbing Spray with Lidocaine, (lidocaine HCL 4%), 1/2 oz Spray (NDC 69804-015-08), 1 oz Spray (NDC...
Inhaled / Nasal Drugs·0 affected·Nov 3, 2017
High RiskFDA
Stryker Neurovascular
Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 4 mm, 20 mm, ; Trevo(TM) Pro 18, TREVO PRO 18 MICROCATHETER, 0.021 in ...
Surgical Devices·2 affected·Nov 3, 2017
High RiskFDA
Alden Optical
NovaKone Toric Daily Wear Soft contact; Catalog Number: AONKT54 Product Usage: The NOVAKONE TORIC lens is indicated for daily wear fo...
Medical Devices·33 affected·Nov 3, 2017
High RiskFDA
Madison Polymeric Engineering
First Step Flexible Endoscope Bedside Pre-Clean Kit, EP-4. Intended for pre-clean of outer surface of flexible scopes and surgical instru...
Surgical Devices·285 affected·Nov 3, 2017
High RiskFDA
Beckman Coulter Inc.
UniCel DxH800, Part Numbers: 629029 and B24802, automated hematology analyzer
Medical Devices·15 affected·Nov 3, 2017
High RiskFDA
Stryker Neurovascular
Trevo(TM) XP ProVue Procedure Pack, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm, .Excelsior(TM) XT-27(TM) 1 TIP STRAIGHT, 150 cm, 6 cm, Mi...
Surgical Devices·1 affected·Nov 3, 2017
High RiskFDA
Beckman Coulter Inc.
UniCel DxH600, Part Number B23858, automated hematology analyzer (Note: the DxH 600 is the same instrument as the DxH 800 except tha...
Medical Devices·1 affected·Nov 3, 2017
High RiskFDA
Beaver-visitec International Inc.
bvi Beaver EdgeAhead Safety Knife, (a) Sideport MVR .90mm 20G, REF 370531 (b) Sideport Angled, .60mm (23G), REF 378233 Product Usag...
Surgical Devices·45 affected·Nov 3, 2017
High RiskFDA
Brainlab Ag
BRAINLAB EXACTRAC VERO, Model/Catalog Numbers: 46228 EXACTRAC VERO 3.5 46238 EXACTRAC VERO 3.5 46216 EXACTRAC VERO SW UPDATE 3.5.2 T...
Medical Devices·28 affected·Nov 3, 2017
High RiskFDA
Beaver-visitec International Inc.
bvi Beaver Safety Sideport Knife: (a) 1.0mm, 45o, REF 378210 (b) 1.2mm, 45o, REF 378212 (c) 115mm, 45o, REF 378231 Product Usage: ...
Surgical Devices·572,490 affected·Nov 3, 2017
High RiskFDA
Alden Optical
Alden Classic 38 Sphere Daily Wear Soft contact; Catalog Number: AOCLS38 Product Usage: The ALDEN SPHERE LENS for daily wear is indic...
Medical Devices·4 affected·Nov 3, 2017
High RiskFDA
Stryker Neurovascular
Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm; Excelsior(TM) XT-27(tm), MICROCATHETER,150 cm, 6 cm; AXS ...
Surgical Devices·2 affected·Nov 3, 2017
High RiskFDA
Medtronic Inc.
Everflex Self-Expanding Peripheral Stent with Entrust Delivery System Intended to improve luminal diameter in the treatment of symptoma...
Medical Implants·21 affected·Nov 3, 2017
High RiskFDA
Handicare Usa Inc
Handicare C Series Patient Lift Product Usage: A device used to lift and transport a patient from one place to another.
Medical Devices·716 affected·Nov 3, 2017
High RiskFDA
Volcano Corporation
Volcano Imaging System s5i REF 807400001; CORE Mobile Imaging System (120V) REF 400-0100.01; CORE Mobile Imaging System Refurbished REF 4...
Medical Devices·1,166 affected·Nov 3, 2017
High RiskFDA
Alden Optical
NovaKone Daily Wear Soft contact; Catalog Number: AONKS54 Product Usage: The NOVAKONE SPHERICAL lens is indicated for daily wear for ...
Medical Devices·3 affected·Nov 3, 2017
High RiskFDA
Alden Optical
Alden HP59 Toric Daily Wear Soft contact; Catalog Number: AOHPT59 Product Usage: The ALDEN TORIC LENS for daily wear is indicated for...
Medical Devices·5 affected·Nov 3, 2017
High RiskFDA
Alden Optical
Alden HP49 Toric Daily Wear Soft contact; Catalog Number: AOHPT49 Product Usage: The ALDEN TORIC LENS for daily wear is indicated for...
Medical Devices·56 affected·Nov 3, 2017
High RiskFDA
Krispy Kreme Doughnut Corporation
Krispy Kreme Doughnuts, Glazed Pumpkin Spice Cake Doughnuts, Net Wt. 13.5oz (half dozen), Manufactured under the authority of Krispy Krem...
Bakery & Grains·4,041 affected·Nov 2, 2017
CriticalFDA
Tradewind Foods De Puerto Rico Inc.
GOYA Adobo, All Purpose Seasoning with Pepper, Goya Foods, Inc. 28 OZ
Food·6,864 affected·Nov 2, 2017
RecallFDA
Gourmet International Inc.
Premio Strawberry Pralinati, Strawberry with Cocoa, 3.53oz, 10 units per case, packed in Paper Cartons
Produce·24,179 affected·Nov 2, 2017
High RiskFDA
Krispy Kreme Doughnut Corporation
Krispy Kreme Doughnuts, Glazed Mini Crullers, Net Wt. 10 oz, Manufactured under the authority of Krispy Kreme Doughnut Corporation, Winst...
Food·4,041 affected·Nov 2, 2017
High RiskFDA
Krispy Kreme Doughnut Corporation
Krispy Kreme Doughnuts, Original Glazed Doughnut Holes, Manufactured under the authority of Krispy Kreme Doughnut Corporation, Winston-Sa...
Food·4,041 affected·Nov 2, 2017
High RiskFDA
Krispy Kreme Doughnut Corporation
Krispy Kreme Doughnuts, Glazed Blueberry Cake Doughnuts, Net Wt. 13.5oz (half dozen), Manufactured under the authority of Krispy Kreme Do...
Bakery & Grains·4,041 affected·Nov 2, 2017
High RiskFDA
Krispy Kreme Doughnut Corporation
Krispy Kreme Doughnuts, Glazed Cake, Doughnut Holes, Manufactured under the authority of Krispy Kreme Doughnut Corporation, Winston-Salem...
Bakery & Grains·4,041 affected·Nov 2, 2017
High RiskFDA
Kellbran Candies And Snacks Inc
DRIZZLED VANILLA POPCORN Net Wt. 3 oz (84.9g) Ingredients: Popcorn, corn syrup, sugar, lecithin***ALLERGY INFO: Manufactured in a facilit...
Dairy·520 affected·Nov 2, 2017
High RiskFDA
Krispy Kreme Doughnut Corporation
Krispy Kreme Doughnuts, Glazed Mini Crullers, Krispy Juniors, Manufactured under the authority of Krispy Kreme Doughnut Corporation, Wins...
Food·4,041 affected·Nov 2, 2017
High RiskFDA
Krispy Kreme Doughnut Corporation
Krispy Kreme Doughnuts, Original Glazed Doughnuts, Net Wt. 9.4oz (half dozen) and Net Wt. 18.7oz (one dozen), Manufactured under the auth...
Food·4,041 affected·Nov 2, 2017
CriticalFDA
Tradewind Foods De Puerto Rico Inc.
GOYA Adobo, All Purpose Seasoning with Cumin, Goya Foods, Inc. 28 OZ
Food·1,236 affected·Nov 2, 2017
High RiskFDA
Epigenomics Ag
Epi proColon Plasma Quick Kit; Catalog Number: M5-02-001: Consists of 1x Lysis Binding Buffer, 1x Wash B Concentrate, 1x Dilution Buffer,...
Medical Devices·200 affected·Nov 2, 2017