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
Zydus Pharmaceuticals (usa) Inc
Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100 Tablets (10x10 unit dose) blister pack, Rx only, Manufactured by: ...
Oral Drugs·15,144 affected·Dec 3, 2020
High RiskFDA
Zydus Pharmaceuticals (usa) Inc
Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 100 Tablets (10 x 10 unit-dose) blister pack, Rx only, Manufactured by...
Oral Drugs·22,848 affected·Dec 3, 2020
High RiskFDA
Flowers Foods (corporate Offices)
CANYON BAKEHOUSE GLUTEN FREE BAGELS EVERYTHING NET WT. 14 OZ (396g) Canyon Bakehouse, LLC Johnstown, CO 80534 UPC 8 53584 00221 8
Food·384 affected·Dec 2, 2020
High RiskFDA
Flowers Foods (corporate Offices)
CANYON BAKEHOUSE GLUTEN MOUNTAIN WHITE BREAD NET WT. 18oz (1lb 2oz) 510g Canyon Bakehouse, LLC Johnstown, CO 80534 UPC 8 53584 00200 3
Bakery & Grains·1,024 affected·Dec 2, 2020
High RiskFDA
Beckman Coulter Inc.
MicroScan Pos MIC Panel Type 34 - Product Usage: For the determination of antimicrobial agent susceptibility and/or identification to the...
Medical Devices·685 affected·Dec 2, 2020
High RiskFDA
Boston Scientific Corporation
EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209
Medical Devices·7,093 affected·Dec 2, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica IM 1300 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11066001 - Product ...
Diagnostic Devices·1,095 affected·Dec 2, 2020
High RiskFDA
Icu Medical, Inc.
60" (152 cm) Appx 1.9 ml, Smallbore Ext Set w/MicroClave¿ Clear, 1.2 Micron Filter, 2 Clamps, Luer Lock REF MC330174 - Product Usage: The...
Surgical Devices·7,500 affected·Dec 2, 2020
CriticalFDA
Boston Scientific Corporation
EMBLEM S-ICD Model A209
Medical Devices·1,953 affected·Dec 2, 2020
High RiskFDA
Boston Scientific Corporation
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
Medical Devices·11,296 affected·Dec 2, 2020
High RiskFDA
Steris Corporation
Vis-U-All High Temp 7.5"x13.5" Heat Seal Pouch 200 pouches per box; 5 boxes per case Model Number: 883713
Medical Devices·31 affected·Dec 2, 2020
High RiskFDA
Steris Corporation
Vis-U-All High Temperature Tubing 9"x100'. One roll per box; 10 boxes per case 6 rolls/cs Model Number: 881091
Medical Devices·197 affected·Dec 2, 2020
High RiskFDA
Steris Corporation
Vis-U-All High Temp 13"x18" Self Seal Pouch 100 pouches per box; 4 boxes per case Model Number: 884118
Medical Devices·589 affected·Dec 2, 2020
High RiskFDA
Steris Corporation
Vis-U-All High Temp 3.5"x9" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884039
Medical Devices·170 affected·Dec 2, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH 930 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11067000 - Product U...
Diagnostic Devices·2,405 affected·Dec 2, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica IM 1600 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11066000 - Product ...
Diagnostic Devices·1,588 affected·Dec 2, 2020
High RiskFDA
Steris Corporation
Vis-U-All High Temp 6"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per case Model Number: 883610
Medical Devices·54 affected·Dec 2, 2020
CriticalFDA
Boston Scientific Corporation
EMBLEM MRI S-ICD Model A219
Medical Devices·872 affected·Dec 2, 2020
High RiskFDA
Steris Corporation
Vis-U-All High Temperature Tubing 6"x100'. One roll per box; 10 boxes per case 10 rolls/cs Model Number: 881061
Medical Devices·98 affected·Dec 2, 2020
High RiskFDA
Icu Medical, Inc.
154 cm (61 IN) APPX 1.5ml, PUR YELLOW EXT, 1.2 MICRON FILTER - Product Usage: The intravascular administration set is a single use, steri...
Surgical Devices·7,500 affected·Dec 2, 2020
High RiskFDA
Steris Corporation
Vis-U-All High Temp 5.5"x10" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884510
Medical Devices·229 affected·Dec 2, 2020
High RiskFDA
Roche Diagnostics Operations, Inc.
CoaguChek XS PST Meters- IVD (Patient Self-Testing) measures blood-clotting time for people who are taking anticoagulation medications su...
Medical Devices·716,880 affected·Dec 2, 2020
High RiskFDA
Icu Medical, Inc.
7 IN (18cm) APPX 0.43ml, SMALLBORE SET, MicroCLAVE, FILTER SetSource - Product Usage: The intravascular administration set is a single us...
Surgical Devices·7,500 affected·Dec 2, 2020
High RiskFDA
Roche Diagnostics Operations, Inc.
CoaguChek XS Prof (Professional) Meters- IVD professional healthcare providers for quantitative prothrombin time testing for the monitori...
Medical Devices·212,093 affected·Dec 2, 2020
CriticalFDA
Maribel's Sweets, Inc.
CACAO MARKET MARIE BELLE NEW YORK; Dark Chocolate Pearls; Ingredients: Cocoa bean, sugar, biscuit cereals (wheat flour, sugar, wheat malt...
Dairy·21 affected·Dec 1, 2020
RecallFDA
Meijer Distribution
True Goodness by Meijer Organic Green Peas Frozen 10 Oz plastic bag UPC 7-08820-73708-2, 12 bags per case-pack
Frozen Food·6,539 affected·Dec 1, 2020
High RiskFDA
Gaza Proveedora De Servicios De Hospedaje Y Alimentacion
Zapien Productos Hand Sanitizer Gel Antibacterial, 33.8 FL. OZ (1000 mL), Made by GAZA S.A. DE C.V. Castilla St. #1473-A ZIP 45410 Tonala...
Topical Drugs·43,875 affected·Dec 1, 2020
High RiskFDA
Gaza Proveedora De Servicios De Hospedaje Y Alimentacion
Pristine gel Hand Sanitizer Gel Antibacterial Gel Moisturizing, 8.45 Fl. Oz. (250 mL) Bottle, Distributed by: Universal Distributors LLC,...
Topical Drugs·26,000 affected·Dec 1, 2020
High RiskFDA
Boston Scientific Corporation
Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm (OUS) UPN: M00553560 - Product Usage: The stent is intended for ...
Medical Implants·78 affected·Dec 1, 2020
High RiskFDA
Boston Scientific Corporation
AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm UPN: M00553660 - Product Usage: The stent is intended for implantati...
Medical Implants·38 affected·Dec 1, 2020
High RiskFDA
Biomet, Inc.
Vanguard 360 Revision System Posterior Augment With Bolt - Product Usage: intended for use in knee arthroplasty Item Number: 185422
Medical Devices·21 affected·Dec 1, 2020
High RiskFDA
Boston Scientific Corporation
Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm (OUS) UPN: M00553550 - Product Usage: The stent is intended for ...
Medical Implants·61 affected·Dec 1, 2020
High RiskFDA
Pacific Coast Producers
Tomato Paste in a 6 oz.(170g) metal can Cases size varies - 12, 24 or 28 count. Packaged under brand names of: Happy Harvest, Krog...
Produce·31 affected·Nov 30, 2020
High RiskFDA
Pacific Coast Producers
Italian Style Tomato Paste in a 6 oz. (170g) metal can Cases size varies - 12, 24 or 28 count. Packaged under brand names of: Krog...
Produce·31 affected·Nov 30, 2020
High RiskFDA
Advanced Nutriceuticals, Llc
BPC-157, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Drugs·4 affected·Nov 30, 2020
High RiskFDA
Advanced Nutriceuticals, Llc
GHRP, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Drugs·1 affected·Nov 30, 2020
High RiskFDA
Advanced Nutriceuticals, Llc
THYMOSIN ALPHA, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Drugs·4 affected·Nov 30, 2020
High RiskFDA
Advanced Nutriceuticals, Llc
LL-37, 2000 MCG/ML, 2 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Drugs·1 affected·Nov 30, 2020
High RiskFDA
Advanced Nutriceuticals, Llc
AOD-9604, 1200 MCG/ML, 5 ML vial The Guyer Institute of Molecular Medicine, Indianapolis, IN
Drugs·3 affected·Nov 30, 2020
High RiskFDA
Advanced Nutriceuticals, Llc
CEREBROLYSIN, 107.5 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Drugs·1 affected·Nov 30, 2020
High RiskFDA
Advanced Nutriceuticals, Llc
THYMOSIN BETA - 4, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Drugs·3 affected·Nov 30, 2020
High RiskFDA
Advanced Nutriceuticals, Llc
HIGH DOSE B12, 10 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Drugs·1 affected·Nov 30, 2020
High RiskFDA
Advanced Nutriceuticals, Llc
CJC-1295, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Drugs·6 affected·Nov 30, 2020
High RiskFDA
Advanced Nutriceuticals, Llc
B12 for Injection, 2 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Injectable Drugs·1 affected·Nov 30, 2020
High RiskFDA
Advanced Nutriceuticals, Llc
FGL, 10 MG/ML, 3 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Drugs·1 affected·Nov 30, 2020
High RiskFDA
Advanced Nutriceuticals, Llc
GHK-CU, 10 MG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Drugs·1 affected·Nov 30, 2020
High RiskFDA
Advanced Nutriceuticals, Llc
Pentosan Polysulfate, 300 MG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Drugs·1 affected·Nov 30, 2020
High RiskFDA
Advanced Nutriceuticals, Llc
DSIP, 1000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Drugs·1 affected·Nov 30, 2020