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
Dr. Reddy's Laboratories, Inc.
Divalproex Sodium Extended-Release Tablets, USP, (valproic acid activity), 250 mg, 100 count (NDC 55111-533-01) and 500 count (NDC 55111-...
Oral Drugs·100 affected·May 22, 2015
RecallFDA
Novartis Pharmaceuticals Corp.
Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule, 12 Capsules (Blister strips of 6) per pack. For inhalation...
Oral Drugs·19,658 affected·May 22, 2015
High RiskFDA
Blenheim Pharmacal, Inc.
Clarithromycin Tablets, USP, 500 mg, 20 Tablets, Rx Only, Dist. By: Wockhardt USA LLC, Parsippany, NJ 07054, Repackaged By: Blenheim Phar...
Oral Drugs·50 affected·May 22, 2015
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
0702-001-350Q, Diverter Valve Assembly 0702-001-000, Neptune 2 Rover Ultra (120V) 0702-001-000R, Repair Neptune 2 Rover 0702-002-000,...
Surgical Devices·9,245 affected·May 22, 2015
CriticalFDA
Osamu Corporation
Frozen Tuna Ground Indonesia/Wild Caught Label on outer shipping cardboard box: Frozen Tuna Fillet Restaurant Supply Only Packe...
Seafood·88,569 affected·May 21, 2015
High RiskFDA
Medtech Products, Inc.
SUCRETS Sore Throat & Cough Vapor Cherry lozenges, 18-count tin, Dist. By: Insight Pharmaceuticals, LLC, Trevose, PA 19053-8433
Drugs·107,832 affected·May 21, 2015
High RiskFDA
Takeda Pharmaceuticals North America, Inc.
CONTRAVE (naltrexone HCl and bupropion HCl )extended-release tablets, 8 mg/ 90 mg, 120-count bottle, Rx only, Manufactured for Orexigen T...
Oral Drugs·3,619 affected·May 21, 2015
High RiskFDA
Exactech, Inc.
Exactech Single Barrel Drill Guides The Single Barrel Drill Guide is a nonpowered hand-held device intended for medical purposes to mani...
Medical Devices·2 affected·May 21, 2015
High RiskFDA
Baxter Healthcare Corp
ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET NEEDLE-FREE IV CONNECTOR WITH NEUTRAL FLUID DISPLACEMENT
Surgical Devices·23,600 affected·May 21, 2015
High RiskFDA
Intuitive Surgical, Inc.
Thoracic Grasper, 5 MM, for use with da Vinci S (IS2000) and SI (IS3000) Surgical Systems. Intended for endoscopic manipulation of tis...
Surgical Devices·2,436 affected·May 21, 2015
High RiskFDA
Exactech, Inc.
Exactech Ambassador Cervical Plate System The Exactech Ambassador Cervical Place System is intended for anterior cervical fixation (C2-...
Medical Devices·4 affected·May 21, 2015
High RiskFDA
Rti Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Bullet-Tip PEEK VBR/IBF System, 32mm(l) 13mm(H) Implant 32-13-32 UDI (01)008464680341 08(17)191218(10)200827; T-Plus PEEK VBR/IBF System,...
Medical Implants·18 affected·May 21, 2015
CriticalFDA
Aksar Llc
AKSAR (life taste and beyond) Cashew Pieces 4040615 Net Wt: 7oz (200gm) , Net Wt: 28oz (800gm) 4051315 Net Wt: 400 gms (14oz)...
Food·4,708 affected·May 20, 2015
High RiskFDA
Texas Pack, Inc.
Brown Peeled and De-veined Shrimp, (U/10, U/12, 10/15, 16/20, 21/25, 26/30, 31/35, 36/40, 41/50, 51/60, 61/70, 71/80, 81/90, Large Pcs, M...
Seafood·3,653 affected·May 20, 2015
High RiskFDA
Mylan Lab Inc
Mycophenolic Acid Delayed-release Tablets, 180 mg, 120-count bottle, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., N...
Oral Drugs·7,722 affected·May 20, 2015
High RiskFDA
Fresenius Medical Care Holdings, Inc.
NaturaLyte Liquid Bicarbonate Concentrate (Dialysate Concentrate for Hemodialysis (liquid), 6.4 Liter Bottle Catalog Number: 08-4000-LB ...
Medical Devices·1,856,619 affected·May 20, 2015
High RiskFDA
Northern Digital Inc.
NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgery) system. Product Usage: Disposable reflective marker ...
Surgical Devices·32,400 affected·May 20, 2015
Medium RiskFDA
Hospira Inc.
Magnesium Sulfate Injection, USP, 50%, 20mL, Single dose Fliptop Vial, For IV or IM use, Rx only, Manufactured by Hospira, Inc. 4285 Wes...
Injectable Drugs·106,900 affected·May 19, 2015
High RiskFDA
Pointe Scientific, Inc.
Pointe Scientific G6PD Controls Kit configuration: 6 x 0.5 ml (2 vials each of Level 1, Level 2 and Level 3). Also sold as individual ...
Diabetes Devices·2,772 affected·May 19, 2015
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
CentraLink" Data Management System; software is a network solution provider and multi-system data manager for the instruments and lab aut...
Medical Devices·1,941 affected·May 19, 2015
High RiskFDA
Remel Inc
VersaTREK Instrument Series 240 REF 6240, Manufactured for Remel Inc. The VersaTREK System is for cultivating and recovering microorga...
Medical Devices·143 affected·May 19, 2015
High RiskFDA
Michael Zakany Llc
Jose Madrid Salsa Mild NET WT. 13 OZ. (369 g.) www.josemadridsalsa.com Jose Madrid Salsa PO Box 1061 Zanesville, OH 43702 740.221.3934 RE...
Food·8 affected·May 18, 2015
High RiskFDA
Advanced Physician Solutions, Inc.
HYDROXYZINE HYDROCHLORIDE (STERILE WATER) (10ML VIAL) 25MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywoo...
Injectable Drugs·2 affected·May 18, 2015
High RiskFDA
Advanced Physician Solutions, Inc.
SODIUM TETRADECYL SULFATE (STERILE WATER) (30ML) 3.5% INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605
Injectable Drugs·1 affected·May 18, 2015
High RiskFDA
Advanced Physician Solutions, Inc.
HYDROXYPROGESTERONE CAPROATE (OLIVE OIL) 30ML, 10ML VIAL 250MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Holl...
Injectable Drugs·28 affected·May 18, 2015
High RiskFDA
Advanced Physician Solutions, Inc.
HYDROXYZINE HYDROCHLORIDE (30ML VIAL) (STERILE WATER) 50MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywoo...
Injectable Drugs·3 affected·May 18, 2015
High RiskFDA
Advanced Physician Solutions, Inc.
ESTRADIOL CYPIONATE (SESAME OIL) (10ML, 30ML VIAL) 40MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood,...
Injectable Drugs·6 affected·May 18, 2015
High RiskFDA
Advanced Physician Solutions, Inc.
ESTRADIOL VALERATE (SESAME OIL) 10ML VIAL 10MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605
Injectable Drugs·1 affected·May 18, 2015
High RiskFDA
Advanced Physician Solutions, Inc.
NANPYRIDOXINE (STERILE WATER) 30ML 50MG/ML INJECTABLE,Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605
Injectable Drugs·30 affected·May 18, 2015
High RiskFDA
Advanced Physician Solutions, Inc.
DMSO (STERILE WATER) SOLUTION -50ML VIAL 50% INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605
Injectable Drugs·41 affected·May 18, 2015
High RiskFDA
Advanced Physician Solutions, Inc.
NANDROLONE DECANOATE (SESAME OIL) 100ML VIAL 200MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 9...
Injectable Drugs·32 affected·May 18, 2015
High RiskFDA
Advanced Physician Solutions, Inc.
ESTRADIOL VALERATE (10ML VIAL) SESAME OIL 45MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605
Injectable Drugs·17 affected·May 18, 2015
High RiskFDA
Advanced Physician Solutions, Inc.
GLUTATHIONE 200MG/ML (STERILE WATER) (30ML, 50ML VIAL) INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA ...
Injectable Drugs·0 affected·May 18, 2015
High RiskFDA
Advanced Physician Solutions, Inc.
SODIUM HYALURONATE (2ML PREFILLED SYRINGE) STERILE WATER 20MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Holly...
Injectable Drugs·416 affected·May 18, 2015
High RiskFDA
Advanced Physician Solutions, Inc.
SODIUM HYALURONATE (STERILE WATER) 2.5 ML VIAL 20MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 9...
Injectable Drugs·21 affected·May 18, 2015
High RiskFDA
Advanced Physician Solutions, Inc.
VITAMIN D3 (OLIVE OIL) (30ML VIAL) 50,000 UNITS/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605
Injectable Drugs·2 affected·May 18, 2015
High RiskFDA
Advanced Physician Solutions, Inc.
SODIUM TETRADECYL (STERILE WATER) 30ML VIAL 2% INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605
Injectable Drugs·1 affected·May 18, 2015
High RiskFDA
Advanced Physician Solutions, Inc.
CYANOCOBALAMIN (PARABEN WATER) (10ML, 30ML VIAL) 2000MCG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood...
Injectable Drugs·77 affected·May 18, 2015
High RiskFDA
Advanced Physician Solutions, Inc.
ESTRADIOL CYPIONATE (SESAME OIL) 10ML, 30ML VIAL 5MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA ...
Injectable Drugs·21 affected·May 18, 2015
High RiskFDA
Advanced Physician Solutions, Inc.
GLYCERIN (STERILE WATER) 100ML 71% INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605
Injectable Drugs·1 affected·May 18, 2015
High RiskFDA
Coreva Health Science Llc
ActCel advanced bleeding control Topical Hemostatic Dressing 2in X 2in (5cm X 5cm) 4in X 4in Sterile Contents Soluble Regenerated ...
Medical Devices·180,900 affected·May 18, 2015
High RiskFDA
Varian Medical Systems Inc
Surface Applicator Set with Leipzig-style Cone. Brachytherapy applicator set.
Medical Devices·46 affected·May 18, 2015
High RiskFDA
Montana Compounding Pharmacy
Glutathione INHALATION (PF), solution, 100mg/mL, 4 mL vial, Rx only, dispensed by Montana Compounding Pharmacy, Missoula, MT.
Drugs·20 affected·May 15, 2015
High RiskFDA
Montana Compounding Pharmacy
Bimix (PHENT;PAP) (N), solution, (10/300) 1 - 30 mg/mL, injectable, 5ml vial, Rx only, compounded by Montana Compounding Pharmacy in Miss...
Injectable Drugs·1 affected·May 15, 2015
High RiskFDA
Montana Compounding Pharmacy
Hyaluronidase (RM ONLY), Injectable Solution, 150 U/mL, 10ML vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT
Injectable Drugs·20 affected·May 15, 2015
High RiskFDA
Montana Compounding Pharmacy
Alprostadil (PFE1), solution, 30 mcg/mL, injectable, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT
Injectable Drugs·1 affected·May 15, 2015
High RiskFDA
Montana Compounding Pharmacy
Trimix (PGE1;PHENT;PAP) (N), injectable, (100/10/240) 10UG, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT
Injectable Drugs·25 affected·May 15, 2015
High RiskFDA
Montana Compounding Pharmacy
Alprostadil (PFE1), Solution, 10 mcg/mL, injectable, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT
Injectable Drugs·1 affected·May 15, 2015