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
National Foodworks Services
Soozie s Doozies Sugar Cinnamon Snickerdoodle Cookie Dough, 16 ounce, plastic pouch, 6 pouches per case
Bakery & Grains·346 affected·May 2, 2018
CriticalFDA
Utz Quality Food Inc
Good Health Organic Tortillas; Black Bean & Rice; Net Wt 5.5 oz; Distributed by Good Health Natural Products, Inc. Greensboro, NC; UPC: 2...
Food·5 affected·May 2, 2018
CriticalFDA
Badger Botanicals Llc
Acadica Kratom: Red Hulu 2, 250g bags
Food·0 affected·May 2, 2018
High RiskFDA
Galt Medical Corporation
1) Drainer Centesis Catheter, Sterile EO, Rx Only, Catalog #: a) DRC-001-05, b) DRC-001-06, c) DRC-001-15, 2) Centeze Centesis Cath...
Surgical Devices·13,210 affected·May 2, 2018
High RiskFDA
Fresenius Medical Care Renal Therapies Group, Llc
NaturaLyte¿ Liquid Acid Concentrate for Bicarbonate Dialysis, 3.43 Liters, Part Number: 08-3231-1 Product Usage: This concentrate is ...
Medical Devices·1,060 affected·May 2, 2018
CriticalFDA
The Seaberg Company Inc
Part #: SAM XT-M, Model: Tactical Black or Military
Medical Devices·0 affected·May 2, 2018
High RiskFDA
Galt Medical Corporation
Centeze Centesis Catheter, Catalog #: a) DRC-006-05, b) DRC-006-15,
Surgical Devices·300 affected·May 2, 2018
High RiskFDA
Galt Medical Corporation
Tearaway Introducers, Catalog #: a) BNS-000-07, b) BNS-000-10; c) DIL-015-50; d) DSS-005-11; e) DSS-005-12; f) DSS-006-045; g) DSS-...
Medical Devices·23,777 affected·May 2, 2018
CriticalFDA
The Seaberg Company Inc
Part #: SAM XT-C, Model: Hi-Viz Blue
Medical Devices·0 affected·May 2, 2018
High RiskFDA
Galt Medical Corporation
Elite HV Introducer, Catalog #: a) CLI-200-26; b) CLI-210-16; c) CLI-212-07; d) KCL-212-055
Medical Devices·10,950 affected·May 2, 2018
High RiskFDA
Stryker Neurovascular
AXS Infinity LS Long Sheath:((6F/.088in)/ x 70cm GEN-10800-70, (6F/.088in)/ x 80cm GEN-10800-80, (6F/.088in)/ x 90cm GEN-10800-90) Made ...
Medical Devices·15 affected·May 2, 2018
High RiskFDA
Roche Molecular Systems, Inc.
MagNA Pure 24 System, GMMI: 07290519001 Product Usage: The MagNA Pure 24 System is a fully automated clinical sample extractor. It e...
Medical Devices·163 affected·May 2, 2018
High RiskFDA
Galt Medical Corporation
1) TVS LPA, Sterile EO, Rx Only, Catalog #: a) KIT-071-01; b) KIT-071-03; c) KIT-071-10; d) KIT-071-11; 2) Enhance Transcarotid/Perip...
Medical Devices·8,350 affected·May 2, 2018
High RiskFDA
Galt Medical Corporation
1) ELITE HV, Hemostasis Valve Introducer System, Sterile EO, Rx Only, Catalog #: a) BCL-100-04; b) BCL-100-05; c) BCL-100-06; d) BCL-500-...
Medical Devices·3,160 affected·May 2, 2018
High RiskFDA
Ad-tech Medical Instrument Corporation
AD-TECH Medical Instrument Corporation Drill Sleeve Guides DSG-6-3-090-2.4N utilizing raw material (RM0677) from the following lots from ...
Medical Devices·65 affected·May 2, 2018
CriticalFDA
Heartware
Heartware Medtronic HVAD System for cardiac use. Including the following parts: (a) Controller / Controller Kits, Product numbers: 140...
Cardiac Devices·175,878 affected·May 2, 2018
High RiskFDA
Bob's Red Mill Natural Foods, Inc.
Bob's Red Mill 100% Whole Wheat Bread Mix, Item 1674C194, packaged in flexible packaging bag, 4 bags to a cardboard case, each bag weighs...
Bakery & Grains·400 affected·May 1, 2018
High RiskFDA
Heritage Short Bread, Inc.
Heritage Shortbreaad Lemon Infused Ingredients: Enriched flour, pasteurized cream(milk),sugar, salt, pure crystallized ginger, organic gr...
Dairy·2 affected·May 1, 2018
High RiskFDA
Mylan Institutional, Inc. (d.b.a. Udl Laboratories)
Loxapine Capsules, USP 50 mg, packaged in 100 Unit Dose capsules, Rx only, Manufactured by Mylan Pharmaceuticals Inc. Morgantown, WV 2650...
Oral Drugs·1,152 affected·May 1, 2018
High RiskFDA
Mylan Institutional, Inc. (d.b.a. Udl Laboratories)
Loxapine Capsules, USP 25 mg, packaged in 100 Unit Dose Capsules, Rx only, Manufactured by Mylan Pharmaceuticals Inc. Morgantown, WV 2650...
Oral Drugs·1,065 affected·May 1, 2018
CriticalFDA
Auromedics Pharma Llc
Ampicillin and Sulbactam for Injection, USP, 3 gram*s/vial, For Intramuscular or Intravenous Use, Sterile, Manufactured for: AuroMedics P...
Injectable Drugs·54,720 affected·May 1, 2018
CriticalFDA
Auromedics Pharma Llc
Piperacillin and Tazobactam for Injection, USP 3.375 grams per vial, For Intravenous Use Only, Single-Dose vial, Rx Only, Manufactured fo...
Injectable Drugs·77,400 affected·May 1, 2018
High RiskFDA
Tp Orthodontics, Inc.
Jasper Vektor, Class II Correction Appliance, Part No. 610-527R used for correcting class 2 malocclusions by applying light forces on the...
Medical Devices·1 affected·May 1, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Q.zen floor, Material no. 10848353, for angiography and whole body radiographic/fluoroscopic procedures.
Medical Devices·1 affected·May 1, 2018
High RiskFDA
Keystone Dental Inc
Prima Plus ¿4.1 x 11.5mm Implant, Catalog Number 15737K Keystone Dental implants are intended for use in partially or fully edentulous...
Medical Implants·72 affected·May 1, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Q.zeego, Material no. 10848283, for angiography and whole body radiographic/fluoroscopic procedures.
Medical Devices·4 affected·May 1, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Q biplane, Material no. 10848282, for angiography and whole body radiographic/fluoroscopic procedures.
Medical Devices·5 affected·May 1, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Q ceiling, Material no. 10848281, for angiography and whole body radiographic/fluoroscopic procedures.
Medical Devices·5 affected·May 1, 2018
High RiskFDA
Hobbs Medical, Inc.
Hobbs Bronchial Cytology Brushes, Model Number 4202; 4204; 4206 To be utilized by a trained physician and/or trained personnel through...
Medical Devices·1,820 affected·May 1, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model 10849000
Medical Devices·39 affected·May 1, 2018
High RiskFDA
Tp Orthodontics, Inc.
Jasper Vektor, Class II Correction Appliance, Part No. 610-533Lused for correcting class 2 malocclusions by applying light forces on the ...
Medical Devices·5 affected·May 1, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis zee biplane MN, Material no. 10094143, for angiography and whole body radiographic/fluoroscopic procedures.
Medical Devices·2 affected·May 1, 2018
High RiskFDA
Tp Orthodontics, Inc.
Jasper Vektor, Class II Correction Appliance, Part No. 610-536L used for correcting class 2 malocclusions by applying light forces on the...
Medical Devices·1 affected·May 1, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis zeego, Material no. 10280959 , for angiography and whole body radiographic/fluoroscopic procedures.
Medical Devices·56 affected·May 1, 2018
High RiskFDA
Tp Orthodontics, Inc.
Jasper Vektor, Class II Correction Appliance, Part No. 610-533 used for correcting class 2 malocclusions by applying light forces on the ...
Medical Devices·119 affected·May 1, 2018
High RiskFDA
Tp Orthodontics, Inc.
Jasper Vektor, Class II Correction Appliance, Part No. 610-530 used for correcting class 2 malocclusions by applying light forces on the ...
Medical Devices·126 affected·May 1, 2018
CriticalFDA
Stonewall Kitchen, Llc
STONEWALL KITCHEN Basil Pesto Aioli Net Weight Net 10.25 oz. UPC: 7 11381 03060 8. Product is incorrectly labeled as Basil Pesto, Net Wei...
Food·732 affected·Apr 30, 2018
RecallFDA
Teva Pharmaceuticals Usa
Lidocaine Patch 5% (700 mg) ,(NDC 0591-3525-11), 30 envelopes containing 1 patch each/ 30 Patches/Carton (NDC 0591-3525-30)
Topical Drugs·30,382 affected·Apr 30, 2018
High RiskFDA
Mylan Pharmaceuticals Inc.
PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 15 mg, Rx Only, 48-count bottle, NDC 00378-4715-22
Oral Drugs·9,906 affected·Apr 30, 2018
High RiskFDA
Mylan Pharmaceuticals Inc.
PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 10 mg, Rx Only, 48-count bottle, NDC 00378-4710-22
Oral Drugs·7,334 affected·Apr 30, 2018
High RiskFDA
Mylan Pharmaceuticals Inc.
PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets, 30 mg, Rx Only, 48-count bottle, NDC 00378-4730-22
Oral Drugs·3,844 affected·Apr 30, 2018
High RiskFDA
Philips Electronics North America Corporation
IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865352
Medical Devices·4,488 affected·Apr 30, 2018
High RiskFDA
Philips Electronics North America Corporation
IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865350
Medical Devices·25,499 affected·Apr 30, 2018
High RiskFDA
Polymedco, Inc.,/polymedco Cancer Diagnostic Products, Llc
PATHFAST Myoglobin II reagent cartridge Catalog Number: PF1111-K PATHFAST¿ NTproBNP is a product for in-vitro diagnostic use with the...
Diagnostic Devices·272 affected·Apr 30, 2018
High RiskFDA
Polymedco, Inc.,/polymedco Cancer Diagnostic Products, Llc
PATHFAST NTproBNP Catalog Number: PF1061-KUS PATHFAST¿ NTproBNP is a product for in-vitro diagnostic use with the in vitro diagnosti...
Diagnostic Devices·272 affected·Apr 30, 2018
High RiskFDA
Giovanni Food Company, Inc.
Parade Salsa Hot/Picante NET WT/PESO NETO 24 OZ (1 LB 8 OZ) 680g, UPC: 0 50700 08883 9
Food·1,463 affected·Apr 27, 2018
High RiskFDA
Giovanni Food Company, Inc.
Parade Salsa MEDIUM/MEDIANO NET WT/PESO NETO 24 OZ (1 LB 8 OZ) 680g, UPC: 0 50700 08876 1
Food·1,463 affected·Apr 27, 2018
High RiskFDA
Giovanni Food Company, Inc.
Parade Salsa MILD/SUAVE NET WT/PESO NETO 24 OZ (1 LB 8 OZ) 680g, UPC: 0 50700 08421 3
Food·1,463 affected·Apr 27, 2018