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
CriticalFDA
Designed By Nature Llc
Designed by Nature Cow's Milk Formula: 12 oz. plastic pouch. Easy to Digest, Nutritionally Alive, Developed for All Life Stages. For...
Dairy·171 affected·Jun 14, 2021
High RiskFDA
Wegmans Food Markets, Inc.
Somerdale Red Dragon Cheddar Cheese, cut and repacked in plastic cheese wrap by Wegmans and sold by the pound.
Dairy·1,299 affected·Jun 14, 2021
High RiskFDA
Pacific Meridian Group, Llc
Ful-Flav-R Green Pace Chili Diced 3/8" w Citric Acid; Item # 544-107-7 Net Weight 400 lbs. (181.436 KG) Refrigerate after opening. Ingr...
Food·35 affected·Jun 14, 2021
CriticalFDA
Designed By Nature Llc
Designed by Nature Goat's Milk Formula: Easy to Digest, Nutritionally Alive, Developed for All Life Stages. For the Little Ones in Yo...
Dairy·1,688 affected·Jun 14, 2021
High RiskFDA
Heritage Family Specialty Foods, Inc.
Hatch Verde Salsa Medium Net Wt. 12 oz (340g) 6 jars per case packaged in clamshell container UPC Code: 810041591999
Food·646 affected·Jun 14, 2021
High RiskFDA
Heritage Family Specialty Foods, Inc.
E6164J2 Taco Casa Green Salsa 8 x 4 lb (1.8 kg) pouches
Food·779 affected·Jun 14, 2021
CriticalFDA
Designed By Nature Llc
Designed by Nature Base Mix Formula: .375 oz/11 g plastic pouch/ Easy to Digest, Nutritionally Alive, Developed for All Life Stages. F...
Baby Food & Formula·0 affected·Jun 14, 2021
High RiskFDA
Roi Cps Llc
Regard NEWBORN KIT, LD00201K, Item Number: 830016011. Medical convenience kit which includes an infant heel warmer.
Medical Devices·688 affected·Jun 14, 2021
CriticalFDA
Philips Respironics, Inc.
Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators.
Respiratory Devices·255,810 affected·Jun 14, 2021
High RiskFDA
Ion Beam Applications S.a.
Proteus 235- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susce...
Medical Devices·27 affected·Jun 14, 2021
High RiskFDA
Roi Cps Llc
Regard NEWBORN KIT, LD00201M, Item Number: 830016013. Medical convenience kit which includes an infant heel warmer.
Medical Devices·976 affected·Jun 14, 2021
High RiskFDA
Arthrex, Inc.
Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC
Medical Devices·3,985 affected·Jun 14, 2021
High RiskFDA
Roi Cps Llc
Regard NEWBORN KIT, LD00201j, Item Number: 830016010. Medical convenience kit which includes an infant heel warmer.
Medical Devices·608 affected·Jun 14, 2021
High RiskFDA
Ge Healthcare, Llc
Revolution EVO, Optima CT660, Optima CT680 CT Systems.
Medical Devices·3,665 affected·Jun 14, 2021
CriticalFDA
Philips Respironics, Inc.
A-Series BiPAP A 40, A-Series BiPAP A30 Continuous Ventilator, Non-life Supporting
Respiratory Devices·72,665 affected·Jun 14, 2021
High RiskFDA
Larsen's Creamery, Inc.
Bulk Salted Butter, item #502. Butter solid block is packaged in carton case with plastic liner, net wt. 55 lb. (25kg). The label is re...
Dairy·798 affected·Jun 11, 2021
High RiskFDA
Medtronic Heart Valves Division
CoreValve Evolut PRO Delivery Catheter System, REF: ENVPRO-14; ENVPRO-16;
Surgical Devices·67,339 affected·Jun 11, 2021
High RiskFDA
Cipla
Solifenacin Succinate Tablets, 10 mg, 30-count bottles, Rx Only, Manufactured by: Cipla Ltd., Verna, Goa, India Manufactured for Cipla US...
Oral Drugs·7,228 affected·Jun 10, 2021
High RiskFDA
Abbott Laboratories
REF 8L92-42, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740161866
Medical Devices·2,212 affected·Jun 10, 2021
CriticalFDA
Arjohuntleigh Polska Sp. Z.o.o.
Arjo Citadel beds originally assembled with the IndiGo modules during manufcturing, model number CX812A3J3AMAD0; and IndiGo modules (retr...
Medical Devices·367 affected·Jun 10, 2021
High RiskFDA
Abbott Laboratories
REF: 08P1820, Abbott Alinity c Activated Alanine Aminotransferase reagent Kit, Alinity c Activated Alanine Aminotransferase Reagent Kit,...
Diagnostic Devices·4,727 affected·Jun 10, 2021
High RiskFDA
Ge Oec Medical Systems, Inc
OEC 3D Imaging, Image-Intensified Fluoroscopic X-Ray System, Mobile - Product Usage: designed to provide fluoroscopic and digital spot im...
Surgical Devices·3 affected·Jun 10, 2021
High RiskFDA
Merit Medical Systems, Inc.
basixALPHA Inflation Device 30 atm/bar 20 mL - Product Usage: Used to inflate and deflate an angioplasty balloon or other interventional ...
Medical Devices·7,211 affected·Jun 10, 2021
High RiskFDA
Dominguez Foods Of Washington, Inc.
Su Cocina Pan Molido bread crumbs in 8 oz. packages. UPC 6 79790 05912 5. The label of 8 oz. package is read in parts: "***Plain Bread ...
Bakery & Grains·15 affected·Jun 9, 2021
RecallFDA
Avkare Inc.
Phytonadione Tablets 5 mg, Rx Only, 30 Tablets (3x10) Unit Dose, Manufactured for: AvKARE Pulaski, TN 38478. NDC 50268-661-13
Oral Drugs·10 affected·Jun 9, 2021
High RiskFDA
Genentech Inc
Xolair (omalizumab) Injection, 150 mg/1 mL, 1 prefilled syringe, Rx Only, For Subcutaneous Use. Single-Dose Prefilled Syringe. Product of...
Injectable Drugs·88,620 affected·Jun 9, 2021
High RiskFDA
Pfizer Inc.
Chantix (varenicline) tablets, 0.5mg*, 56 Tablets, Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc., NY, NY 10017, Made in Ir...
Oral Drugs·59,232 affected·Jun 9, 2021
High RiskFDA
World Source Llc
QiYu Hand Sanitizer Gel, ethanol, 500 mL bottles (pump), Manufacturer Guangzhou Minghui Cosmetics Co., Ltd., Baiyun District, Guanzhou
Topical Drugs·6,300 affected·Jun 9, 2021
High RiskFDA
Pfizer Inc.
Chantix (varenicline) tablets, 1 mg, 56 Tablets, Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc., NY, NY 10017, Made in Irel...
Oral Drugs·696,396 affected·Jun 9, 2021
High RiskFDA
Pfizer Inc.
Chantix (varenicline)Tablets, Contains: 1 Starting Week (0.5 mg* x 11 tablets), 3 Continuing Weeks (1 mg x 42 tablets), Rx Only, Distribu...
Oral Drugs·350,985 affected·Jun 9, 2021
High RiskFDA
Cordis Corporation
Avanti¿+ Catheter Sheath Introducer - Product Usage: Is indicated for use in arterial and venous procedures requiring percutaneous introd...
Surgical Devices·680 affected·Jun 9, 2021
CriticalFDA
Cardinal Health 200, Llc
Infant Heel Warmer with Attachment Tab, Nonsterile, Active Product SKU MH00002T The infant heel warmer is activated at the point of ...
Medical Devices·926,425 affected·Jun 9, 2021
High RiskFDA
Fo-nd, Llc. (dba Firebird Artisan Mills)
Firebird Artisan Mills Gluten Free Organic Brown Rice Flour, Net Wt: 50 lb / 22.7 kg. 500 North St W., Harvey, ND 58341
Food·31,300 affected·Jun 8, 2021
High RiskFDA
Beechnut Nutrition
Beech-Nut brand Single Grain Rice Baby Cereal; NET WT. 8 OZ (227g); INGREDIENTS: Rice flour, sunflower lecithin; packaged in an 8oz plast...
Bakery & Grains·8,831 affected·Jun 8, 2021
RecallFDA
Prisma Health Outsourcing Facility
Ketamine HCl Injection Solution, 10 mg / 2 mL (5 mg/mL), Rx Only, Compounded by Prisma Health Outsourcing Facility 1071 Holland Rd. Suite...
Injectable Drugs·109 affected·Jun 8, 2021
RecallFDA
Bausch Health Companies, Inc.
Mephyton (Phytonadione) 5 mg tablets, 100-count tablets, Rx Only, Manufactured for: Valeant Pharmaceuticals North America, LLC, Bridgewat...
Oral Drugs·2,691 affected·Jun 8, 2021
RecallFDA
Bausch Health Companies, Inc.
Phytonadione Tablets, 5 mg, 30-count ablets, Rx only, Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals ...
Oral Drugs·37,797 affected·Jun 8, 2021
High RiskFDA
Philips North America Llc
728333 Spectral CT 7500 -Computed Tomography X-ray system
Medical Devices·1 affected·Jun 8, 2021
High RiskFDA
Philips North America Llc
728332 IQon Spectral CT-Computed Tomography X-ray system
Medical Devices·0 affected·Jun 8, 2021
High RiskFDA
Philips North America Llc
728327 Ingenuity CT Upgrades-Computed Tomography X-ray system
Medical Devices·3 affected·Jun 8, 2021
High RiskFDA
Philips North America Llc
728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades
Medical Devices·3 affected·Jun 8, 2021
High RiskFDA
Pear Therapeutics, Inc.
reSET-O Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.
Medical Devices·3,370 affected·Jun 7, 2021
High RiskFDA
Medtronic Vascular, Inc.
Endurant II/Endurant IIs Stent Graft System: Medtronic Endurant II Stent Graft System REF ETUF3214C102EE, ETCF3636C49EE, ETBF3216C166E...
Medical Implants·18 affected·Jun 7, 2021
High RiskFDA
Pear Therapeutics, Inc.
reSET Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.
Medical Devices·812 affected·Jun 7, 2021
High RiskFDA
Bomunity Ltd Co
Paximune Dietary Supplement Contains Bovine Proteins that help Promote Health and help Modulate Immunity 2 Fl. Oz. (60ml) packaged in dar...
Supplements·3,540 affected·Jun 4, 2021
CriticalFDA
Lakeview Farms Llc
Smilin' Bob's All Natural Smoked Fish Dip 8 oz plastic container 12 per case
Seafood·48 affected·Jun 4, 2021
CriticalFDA
Tulkoff Food Products, Inc.
Tulkoff Spicy Kimchi Aioli, 18 fl oz Clear Plastic Squeeze bottle, item number 098001, lot number 09.18.2021M, 8 bottles per case, keep r...
Food·140 affected·Jun 4, 2021
CriticalFDA
Olde Thompson, Llc
Olde Thompson Organic Ground Coriander 1.5oz. in glass jar with flip-top lid. Sun Harvest Organic Coriander 1.5oz in glass jar with flip...
Food·800 affected·Jun 4, 2021