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
Baxter Healthcare Corporation
Prismaflex System, Product Code 107493 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Ther...
Medical Devices·5,880 affected·Apr 24, 2018
High RiskFDA
Medline Industries Inc
MEDLINE O.R. Necessities(R) STERILE R, Needle Counter/Compte-aiguiles/Caja de agujas, Gold Standard/Standard Or/Oro y Estander, 40 Ct. Fo...
Surgical Devices·2,600 affected·Apr 24, 2018
High RiskFDA
Baxter Healthcare Corporation
Prismaflex 7.XX US, Product Code 115269 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement The...
Medical Devices·557 affected·Apr 24, 2018
High RiskFDA
Medline Industries Inc
MEDLINE O.R. Necessities(TM) Sterile* Needle Counter, 100 Ct. Double Magnet / Foam Block with Blade Remover, reorder: NC100FBR Product...
Surgical Devices·80,200 affected·Apr 24, 2018
High RiskFDA
Medline Industries Inc
MEDLINE O.R. Necessities(TM) Sterile* Needle Counter, 40 Ct. Double Magnet / Foam Block with Blade Remover, reorder: NC100FBR Product ...
Surgical Devices·23,150 affected·Apr 24, 2018
High RiskFDA
Baxter Healthcare Corporation
Prismaflex 7.XX ROW, Product Code 114870 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Th...
Medical Devices·2,772 affected·Apr 24, 2018
High RiskFDA
Baxter Healthcare Corporation
Prismaflex 5.10 US, Product Code 113081 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement The...
Medical Devices·1,256 affected·Apr 24, 2018
High RiskFDA
Ziegenfelder Company, Inc.
Budget $aver Monster Cherry-Pineapple Pops Net Contents 36 FL OZ
Food·2,340 affected·Apr 23, 2018
High RiskFDA
Ziegenfelder Company, Inc.
Budget $aver Sugar Free Twin Pops Net Contents 28.2 FL OZ
Food·1,176 affected·Apr 23, 2018
RecallFDA
Mckesson Packaging Services
Diltiazem CD (Diltiazem Hydrochloride Extended-Release Capsules, USP) 180 mg, 100-count bottles, Rx Only Mfg. By: Actavis 60 Columbia Rd...
Oral Drugs·7,656 affected·Apr 23, 2018
RecallFDA
Mckesson Packaging Services
Diltiazem HCl Extended-Release Capsules, USP 240 mg, 100-count bottles, Rx Only, Mfg. By: Par Pharmaceutical One Ram Ridge Rd Chestnut Ri...
Oral Drugs·2,966 affected·Apr 23, 2018
High RiskFDA
Dr. Reddy's Laboratories, Inc.
Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100 Tablets bottle, Rx only, Manufactured by: Dr. Reddy's Laboratories Limite...
Oral Drugs·8,160 affected·Apr 23, 2018
RecallFDA
Mckesson Packaging Services
Diltiazem HCl Extended-Release Capsules, USP 120 mg, 100-count bottles, Rx only, Mfg. By: Par Pharmaceutical One Ram Ridge Rd Chestnut Ri...
Oral Drugs·4,266 affected·Apr 23, 2018
High RiskFDA
Tandem Diabetes Care Inc
t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM Software version: 4.3.4.3, Firmware version: 004722, Firmware, Fuel Gauge, Binary R...
Diabetes Devices·55 affected·Apr 23, 2018
CriticalFDA
Intuitive Surgical, Inc.
da Vinci Xi EndoWrist Stapler 45 Reload Green, Model 48445G-03, 12 reloads/box.
Medical Devices·6,816 affected·Apr 23, 2018
High RiskFDA
Healthy Food Ingredients
Great Value Organic Ground Flax Seed, Net Wt. 16 oz. (1 LB) 454g. UPC 78742-14161, and Net Wt. 32 oz. (2 LB) 907g, UPC 78742-14165 Dist...
Food·8,182 affected·Apr 21, 2018
CriticalFDA
Eden's Ethnos, Llc
Eden's Ethnos Bulk Kratom 25 powder kilogram bag Also called K. Bali Supreme, K Maeng Da Supreme, K Green Vein, Green Maeng Da, K Red M...
Food·2,775 affected·Apr 20, 2018
High RiskFDA
Exela Pharma Sciences Llc
Diclofenac Sodium and Misoprostol Delayed Release Tablets 75 mg/0.2 mg, 60-count bottle, Rx Only, Manufactured by: Cipla Ltd., India; For...
Oral Drugs·5,256 affected·Apr 20, 2018
High RiskFDA
Pintler Medical Llc
A warming pad, a component of the PINTLER PEAK & PINTLER SUMMIT Heated OR pad. PPWS-001 indicated for use in any condition where pat...
Medical Devices·24 affected·Apr 20, 2018
High RiskFDA
Torax Medical, Inc.
LINX Reflux Management System, Implant Clasp, 12-17 Bead, 0.7T, Product Code LX-xx, sterile, Rx only. Labeled as: a. Product Code LX-...
Medical Implants·9,131 affected·Apr 20, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Go.Up, Material Number 11061628 There is a potential for a software issue that may cause the need for necessary patient rescans.
Medical Devices·33 affected·Apr 20, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM go.Now, Material Number 11061618 There is a potential for a software issue that may cause the need for necessary patient resc...
Medical Devices·4 affected·Apr 20, 2018
High RiskFDA
Torax Medical, Inc.
LINX Reflux Management System, Implant Clasp, 12-17 Bead, 0.7T, Product Code LXC-xx, sterile, Rx only. Labeled as: a. Product Code LX...
Medical Implants·9,131 affected·Apr 20, 2018
High RiskFDA
Torax Medical, Inc.
LINX Reflux Management System, Implant Suture, 12-17 Bead, 0.7T, Product Code LS-xx, sterile, Rx only. Labeled as: a. Product Code LS...
Medical Implants·9,131 affected·Apr 20, 2018
High RiskFDA
Sun Pharmaceutical Industries, Inc.
Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg, Rx Only, 500-count bottle, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox ...
Oral Drugs·1,908 affected·Apr 19, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Gentamicin Flex reagent cartridge, DM GENT, gentamicin enzyme immunoassay, Lot numbers affected are EB8115, BB8159, and FB8275.
Diagnostic Devices·7,543 affected·Apr 19, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista Gentamicin Flex reagent cartridge, DV GENT, gentamicin enzyme immunoassay. Affected lots are 17135BC, 17150BF, 17159BD, ...
Diagnostic Devices·20,373 affected·Apr 19, 2018
High RiskFDA
Microaire Surgical Instruments, Llc
MicroAire SmartRelease Endoscopic System, Endoscopic Carpal Tunnel Release, SmartRelease Handpiece, containing IFU rev. D The MicroAir...
Medical Devices·2,009 affected·Apr 19, 2018
High RiskFDA
Maquet Sas
VOLISTA StandOP (model 600) surgical lights shipped from October 2012 until June 2017 equipped with keypads with Ref. ARD568801560; Part ...
Surgical Devices·187 affected·Apr 19, 2018
CriticalFDA
Viable Solutions, Llc
Mitragyna Speciosa Leaf Powder-GREEN Horn, sold under the brand name Herbal-Salvation.com. The powder is packaged in kraft paper, foil-l...
Food·350 affected·Apr 18, 2018
High RiskFDA
Eastland Food Corporation
Asian Best, Tamarind Candy Hot Flavor Net Weight: 4 oz. Units Per Carton: 72 units
Snacks & Candy·970 affected·Apr 18, 2018
CriticalFDA
Superior Foods Company
Smoked Salmon Spread 5 lb. bulk units; Simply Superior Smoked Salmon Spread 5 oz units; and Morey s Smoked Salmon Spread 6 oz units...
Seafood·526 affected·Apr 18, 2018
CriticalFDA
Viable Solutions, Llc
Mitragyna Speciosa Leaf Powder-Thai Maeng Da, sold under the brand name Herbal-Salvation.com. The powder is packaged in kraft paper, foi...
Food·510 affected·Apr 18, 2018
High RiskFDA
Stuffed Foods Llc
Stuffed FOODS Edamame Burger, MFG ITEM # 06100 UPC: 108500821003752 3 - 3lb plastic bags in box
Food·1,552 affected·Apr 18, 2018
High RiskFDA
Naturebox, Inc.
Whole Wheat Chocolate Animal Cookies; 5 oz. pouch, 5 lb. Corporate bags UPC: 8 58950 00508 6 Ingredients: Whole Wheat Flour, Unbleac...
Dairy·1,034 affected·Apr 18, 2018
CriticalFDA
Viable Solutions, Llc
Mitragyna Speciosa Leaf Powder Red Vein Sumatra and Mitragyna Speciosa Leaf Powder Red Vein Bali, sold under the brand name Herbal-Salvat...
Food·350 affected·Apr 18, 2018
High RiskFDA
Canon Medical System, Usa, Inc.
DRAD-3000E (Radrex-i) TFP-4336W (Wireless FPD)
Medical Devices·43 affected·Apr 18, 2018
High RiskFDA
Shawnee Milling Company, Inc.
Hilltop Hearth Self-Rising Flour, Katy s Kitchen Self-Rising Flour, Springwell A1 Flour all packaged in 50 pound paper bags
Food·1,350 affected·Apr 17, 2018
RecallFDA
Rhodes Pharmaceuticals, L.p.
Aptensio XR (methylphenidate HCl extended-release) capsules 15 mg Rx Only 90-count bottle. Marketed by: Rhodes Pharmaceuticals L.P., Cove...
Oral Drugs·2,454 affected·Apr 17, 2018
CriticalFDA
Gyrus Acmi, Incorporated
Gyrus ACMI Reusable Active Cord for Bovie/ValleyLab Generators, Catalog No C650-129A (00821925008700) The cord consists of a single co...
Surgical Devices·6,447 affected·Apr 17, 2018
High RiskFDA
Grato Holdings, Inc.
Energique, Herbal Supplement, Octocom,; Dist. by Energique, Inc. Woodbine, IA 51579
Supplements·845 affected·Apr 16, 2018
High RiskFDA
Grand Canyon Foods International Llc.
Southwestern Gourmet Butter Popcorn Grand Canyon Foods, Phoenix, AZ
Dairy·898 affected·Apr 16, 2018
High RiskFDA
Traditional Medicinals Inc
Traditional Medinicals organic EveryDay Detox Lemon; Naturally Caffeine Free Herbal Tea; 16 wrapped tea bags - Herbal Supplement NET ...
Beverages·9,108 affected·Apr 16, 2018
High RiskFDA
Traditional Medicinals Inc
Traditional Medicinals Throat Coat Lemon Echinacea; Lemon Echinacea, Naturally Caffeine Free Herbal Tea' 16 wrapped tea bags - Herbal S...
Beverages·6,980 affected·Apr 16, 2018
High RiskFDA
Grand Canyon Foods International Llc.
Southwestern Gourmet Prickly Pear Popcorn Grand Canyon Foods, Phoenix, AZ
Snacks & Candy·2,079 affected·Apr 16, 2018
High RiskFDA
Grato Holdings, Inc.
Peaceful Mountain, Nasal Rescue, Dietary Supplement, Natural Sinus Support, Dist. by Peaceful Mountain, Inc. Woodbine, IA 51579
Supplements·27,860 affected·Apr 16, 2018
High RiskFDA
Grato Holdings, Inc.
Peaceful Mountain -Stomach Rescue - Dietary supplement - Elemental silver (45 ppm) 2.7 mg; Dist. by Peaceful Mountain, Inc. Woodbine, IA ...
Supplements·32,213 affected·Apr 16, 2018
CriticalFDA
Epic Products, Llc
Euphoric Premium Male Performance Enhancer capsules, packaged in a)1-count blister cards, UPC 6 96859 28646 9, b) 3-count bottle, UPC 6 9...
Oral Drugs·106,329 affected·Apr 16, 2018