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
Specialty Medicine Compounding Pharmacy
SODIUM HYDROXIDE (BAC.STATIC) 10% SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Drugs·10 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
QUAD MIX* IN NACL (1.8/0.2/0.02)mg/18 mcg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, M...
Injectable Drugs·15 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
HYDROXOCOBALAMIN/THIAMINE* 1 mg/100 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI ...
Injectable Drugs·53 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
HYDROXYPROGEST*-17ALPHA -PF 250 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Injectable Drugs·420 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
CYCLOPENTOLATE HCL* (FOR COMPOUNDING) 2% OPHTHALMIC, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 4...
Ophthalmic Drugs·5 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
NALOXONE HCL* 0.4MG/ML INJECTABLE, all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Injectable Drugs·120 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
Proparacaine HCl PF, 0.5% ophthalmic solution, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Ophthalmic Drugs·6 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
EPINEPHRINE PF SF* (0.3 mL); (1 mL), (0.5 mL IN 3 mL SYRINGE) 1:1000 OPHTH SOL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S...
Drugs·157 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
Polidocanol, 3% injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Injectable Drugs·10 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
WB-Tranexamic acid, 2 g/Placebo 100 mL, DRUG STUDY, packaged as a) 100 mL INJECTABLE, b) TOPICAL, Rx only, Specialty Medicine Compoundin...
Injectable Drugs·1,900 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
VANCOMYCIN HCL 10 mg/mL OPHTHALMIC SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Ophthalmic Drugs·50 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
Hyaluronidase, pf 100U/mL; pf 150 U/mL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Drugs·148 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
Gatifloxacin, 0.2ml 0.5% (ophthalmic) (repackaged), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Ophthalmic Drugs·38 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
Magnesium Sulfate, 1 gm/50 mL; 2 gm/50 mL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Drugs·19,200 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
FLUCON/GENT* (fluconazole and gentamicin) 200 mg/480 mg/1 L SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, ...
Drugs·700 affected·Oct 19, 2013
High RiskFDA
Sunny Pine Farm
Organic Chevre sold at Farmer's Market in plastic 6 oz tubs, vacuum-sealed with lid and label on top of tub, Sunny Pine Farm brand. Pr...
Dairy·121 affected·Oct 18, 2013
High RiskFDA
Sunny Pine Farm
Organic Honey Lavender Chevre is sold in plastic 6 oz tubs under Sunny Pine Farm brand. The product is labeled in parts: "***Organic G...
Dairy·206 affected·Oct 18, 2013
High RiskFDA
Lsg Food World Inc
NOODLES HOUSE HOME STYLE NOODLES, Net Wt. 900 g (31.7 oz), product is packaged in plastic bag with twelve (12) bags per carton. UPC 6 94...
Food·0 affected·Oct 18, 2013
High RiskFDA
Price Chopper Supermarkets
1) 8" Coconut Custard Pie, Net Wt 22 oz (1 lb 6oz), UPC numbers 4173523721 and 4173522453, 2) 10" Coconut Custard Pie, Net Wt 42 oz (2 lb...
Food·36 affected·Oct 18, 2013
High RiskFDA
Lsg Food World Inc
NOODLES HOUSE HOME STYLE NOODLES, Net Wt. 912 g (32 oz), product is packaged in plastic bag with twelve (12) bags per carton. UPC 6 9496...
Food·3,068 affected·Oct 18, 2013
High RiskFDA
Lsg Food World Inc
NOODLES HOUSE HOME STYLE NOODLES, Net Wt. 912 g (32 oz), product is packaged in plastic bag with twelve (12) bags per carton. UPC 6 9496...
Food·1,025 affected·Oct 18, 2013
High RiskFDA
Sunny Pine Farm
Organic Black Pepper Garlic Chevre is sold in 3 lbs. vacuum plastic bag without labels since it sold to restaurants. However, the reta...
Dairy·5 affected·Oct 18, 2013
High RiskFDA
Compounding Centre At Blue Ridge
Quad Mix Injectable, 5 mL, Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC 27607.
Injectable Drugs·1 affected·Oct 18, 2013
High RiskFDA
Compounding Centre At Blue Ridge
PGE 20 mcg/mL Injectable, 10 mL, and PGE 40 mcg/mL, 5 mL, Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC ...
Injectable Drugs·11 affected·Oct 18, 2013
High RiskFDA
Compounding Centre At Blue Ridge
Super Triple Mix Injectable, (aka Dr Lentz Triple Rx Injectable; Dr Kane's Super Triple Rx Injectable; Dr Tortora's Super Triple Rx Injec...
Injectable Drugs·3 affected·Oct 18, 2013
High RiskFDA
Compounding Centre At Blue Ridge
Triple Mix Injectable (aka Dr Ungers Triple Rx; Dr Tortora's Triple Rx; Dr Bennett's Triple Rx; Dr Neighbors Triple Rx Injectable; Dr Le...
Injectable Drugs·92 affected·Oct 18, 2013
High RiskFDA
Compounding Centre At Blue Ridge
Papaverine/Phentolamine 30 mg/mL/2.0 mg/mL Inj, 5 mL units Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC...
Drugs·0 affected·Oct 18, 2013
CriticalFDA
Hospira Inc.
Marcaine (bupivacaine HCl) injection, USP, 0.25%, 30 mL single-dose vials-preservative free, packaged in 10-count vials per carton, Rx on...
Injectable Drugs·40,360 affected·Oct 18, 2013
High RiskFDA
Advanced Sterilization Products
Sterrad 100NX, Product Code: 10104. Used to sterilize heat and moisture sensitive reusable medical devices.
Medical Devices·2,106 affected·Oct 18, 2013
High RiskFDA
Steris Corporation
AMSCO¿ Evolution¿ steam sterilizer Transfer Carriage. Product Usage: Mobile, wheeled transportation unit utilized to carry, load, &#...
Medical Devices·936 affected·Oct 18, 2013
High RiskFDA
Intra Pump Infusion Systems
CRN Crono Syringe CRN20 with 19G x 1 "Steel Needle"
Medical Devices·25,440 affected·Oct 18, 2013
High RiskFDA
Spinefrontier, Inc.
PedFuse Reset Screw; Model: 01-80115-55 The PedFuse Reset pedicle screw implants intended to be used to help provide immobilization an...
Medical Implants·35 affected·Oct 18, 2013
CriticalFDA
Kashmir Crown Baking Llc
KCB Pista Khatie KCB Bakery Products Corp. 56-28 56th Street, Maspeth, NY 11378 Tel: (718) 786-9463 Fax (718) 361-0171 www.kbcusa.com...
Food·24 affected·Oct 17, 2013
High RiskFDA
Nature's Value Inc.
Digestive Enzyme Complex/Enzyme Formula Caps, Quantity:13M, Product #: IB286, product is packaged in bulk form. Manufactured For: Indian...
Baby Food & Formula·796,800 affected·Oct 17, 2013
High RiskFDA
Nature's Value Inc.
Vitacost Super Daily Enzymes 500 mg caps, product is packaged in a plastic bottle with 240 capsules per bottle, UPC Code: 844197017164. ...
Food·796,800 affected·Oct 17, 2013
CriticalFDA
Fahman Enterprises, Inc
Pran Spice Powder Turmeric , 14.10 oz. (400g) clear plastic laminated pouch, UPC 8 3173000502 3
Food·4 affected·Oct 17, 2013
High RiskFDA
Nature's Value Inc.
Vitacost Mega Spectrum Enzyme, packaged with 180 Vegetarian Capsules, UPC Code: 84419701519. Manufactured for Vitacost Lexington, NC 27295
Food·796,800 affected·Oct 17, 2013
High RiskFDA
Baxter Healthcare Corp
15 L Cycler Drainage Bag Product Usage: For use with Baxter Cycler Tubing sets as a peritoneal dialysis accessory.
Medical Devices·3,085,080 affected·Oct 17, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products Na+ Slides, manufactured by Ortho Clinical Diagnostics 513 Technology Blvd Rochester, NY 14652 VITROS Na+ Sl...
Diagnostic Devices·548,663 affected·Oct 17, 2013
High RiskFDA
Philips Medical Systems North America Inc.
EPIQ 7 Ultrasound System, Model 795200, 795201, 795202. Intended for diagnostic ultrasound imaging and fluid flow analysis.
Diagnostic Devices·306 affected·Oct 17, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products Calibrator Kit 2, manufactured by Ortho Clinical Diagnostics 1000 Lee Road Rochester, NY 14606 VITROS Chemis...
Diagnostic Devices·19,368 affected·Oct 17, 2013
High RiskFDA
Zimmer, Inc.
Trabecular Metal" Reverse Shoulder System
Medical Devices·73,002 affected·Oct 17, 2013
High RiskFDA
Spacelabs Healthcare, Llc
Spacelabs Healthcare qube Compact Patient Monitor, Model 91390. It is a patient monitor with arrhythmia detection or alarms. The qube...
Medical Devices·54 affected·Oct 17, 2013
RecallFDA
Taro Pharmaceuticals U.s.a., Inc.
Ciclopirox Shampoo 1%, Net Wt. 120 mL. bottles, Rx only. Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1. Dist. by...
Drugs·850 affected·Oct 16, 2013
RecallFDA
Nanosphere, Inc.
Nanosphere Verigene Each CDF test consists of a Verigene CDF Nucleic Acid Test Kit and a Verigene CDF Amplification Reagent Kit. ...
Diagnostic Devices·280 affected·Oct 16, 2013
CriticalFDA
Cutera, Inc.
Cutera brand truSculpt infrared System (optional), Massager, Vacuum, radio frequency induced heat, Product is manufactured and distribute...
Medical Devices·451 affected·Oct 16, 2013
High RiskFDA
Bausch & Lomb Surgical, Inc.
Bausch & Lomb AKREOS AO Micro Incision Lens The Akreos IOL intended for primary implantation in the capsular bag of the eye for the v...
Medical Implants·336 affected·Oct 16, 2013
High RiskFDA
Microgenics Corp
Thermo Fisher Scientific/Microgenics brand CEDIA Tobramycin II Assay, Catalog Number 100018, Product is manufactured and distributed by ...
Diagnostic Devices·370 affected·Oct 16, 2013