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
www.fda.gov →Official Site

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68,659 recalls
High RiskFDA
Empirical Laboratories, Incorporated
Vive Shake Up Your Health Chocolate; Made for and distributed by renewal wellness.
Snacks & Candy·519 affected·Oct 21, 2013
High RiskFDA
Apex Energetics
RepairVite (K63), Enzyme-Based Herbal & Amino Acid Dietary Supplement Powder, Caramel Flavor, Net Wt. 0.34 lb (155g)
Supplements·8,117 affected·Oct 21, 2013
High RiskFDA
Empirical Laboratories, Incorporated
Empirical Labs Building Health Superfuel; 240 Capsules Dietary Supplement
Supplements·61 affected·Oct 21, 2013
High RiskFDA
Empirical Laboratories, Incorporated
Empirical Labs Building Health Thyroid; 90 Capsules Dietary Supplement
Supplements·22 affected·Oct 21, 2013
CriticalFDA
Medisca Inc.
Human Chorionic Gonadotropin, EP (HCG) in 5 mu. 2 mu, and 1 mu packages, For use and distribution in prescription compounding, manufactur...
Drugs·296 affected·Oct 21, 2013
CriticalFDA
Medtronic Vascular
THUNDER¿ Steerable Guidewire; Model: LVTNDR190S Medtronic guide wires are steerable guide wires that are used for the introduction an...
Diagnostic Devices·1,205 affected·Oct 21, 2013
High RiskFDA
Vital Images, Inc.
VitreaCore¿ software. Versions subject to the limitation: 6.0, 6.1, 6.2, 6.3 (except 6.3.1 ), 6.4 (except 6.4.4 and 6.4.5), as well as ...
Diagnostic Devices·598 affected·Oct 21, 2013
CriticalFDA
Medtronic Vascular
COUGAR¿ Steerable Guidewire; Models: LVCLS190J, LVCLS190S, LVCXT190J, LVCXT190S Medtronic guide wires are steerable guide wires that a...
Diagnostic Devices·20 affected·Oct 21, 2013
RecallFDA
Intuitive Surgical, Inc.
da Vinci Vision System Cart, a component of the da Vinci Si Surgical System IS3000; Y1903 Illuminator (Illuminator + Lamp Module); Y1...
Surgical Devices·161 affected·Oct 21, 2013
CriticalFDA
Medtronic Vascular
ProVia¿ CROSSING GUIDEWIRE; Models: 15PROV300HS, 3PROV180HS, 3PROV180SS, 3PROV300HS, 3PROV300SS, 9PROV180HS, 9PROV180SS Medtronic gui...
Diagnostic Devices·0 affected·Oct 21, 2013
CriticalFDA
Medtronic Vascular
ZINGER¿ Steerable Guidewire; Models: LVZRLS180J, LVZRLS180S, LVZRMS180J, LVZRMS180S, LVZRXT180J, LVZRXT180S Medtronic guide wires are ...
Diagnostic Devices·5 affected·Oct 21, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
0.9% Sodium chloride a) DT-0.9% Sodium chloride* 100 mL Drug Study - IV 100 mL Injectable, b) DT-0.9% Sodium Chloride* 100 mL Drug Study ...
Injectable Drugs·800 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
Combo Eye Gel, HF COMBO EYE GEL* (cyclopentolate 2%, tropicamide 1%, diclofenac sodium 0.1%, ciprofloxacin 0.3%, phenylephrine 10%, lidoc...
Topical Drugs·38 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
Calcium Chloride* PF 500 mg/mL pref syringe, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Drugs·8,090 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
TRANEXAMIC ACID* 2 g/75 mL SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Drugs·3,000 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
Acetylcysteine (PF) 20 % Opthalmic, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Drugs·20 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
Glutathione PF, 60 mg/mL inhalation, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Drugs·126 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
Bevacizumab, (repackaged) in a) 0.11 mL and b) 0.06 mL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI...
Drugs·2,801 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
TROPICAMIDE* 1% OPHTHALMIC SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Ophthalmic Drugs·5 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
DT- Tranexamic Acid* 2 gm/100 mL Drug Study -IV 100 mL injectable, DT-, DT-Tranexamic Acid* 2 gm/100 mL-Drug Study-Topical 100 mL Rx only...
Injectable Drugs·600 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
TESTOS CYPIONATE* IN OIL 100 mg/mL INJECTABLE, TESTOS CYPIONATE* IN OIL 200 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding P...
Injectable Drugs·33 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
NALTREXONE* MDV 1MG/ML INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Injectable Drugs·100 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
METHOCARBAMOL (REPACK) 100 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Injectable Drugs·20 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
Papaverine HCL, 30 mg/mL injectable, also labeled as (10 mL) and (2 mL), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayett...
Injectable Drugs·1,351 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
QUAD MIX* 0.05 mg/25 mg/2 mg/25 mcg/mL INJECTABLE, QUAD MIX* 0.1 mg/30 mg/2 mg/20 mcg INJECTABLE, QUAD MIX* 0.1 mg/30 mg/2 mg/50 mcg INJE...
Injectable Drugs·86 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
GLYCERIN-CHROMATED (W/V)* 72% INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Injectable Drugs·210 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
Neomycin Sulfate* ophthalmic solution, 333 mg/mL, all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyo...
Ophthalmic Drugs·5,582 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
HYDROXOCOBALAMIN* 10,000 mcg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Injectable Drugs·70 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
Phenol, 6%, Injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Injectable Drugs·11 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
METHYLCOBALAMIN * 10 mg/mL INJECTABLE, METHYLCOBALAMIN * UD/PF 25 mg/mL INJECTABLE, METHYLCOBALAMIN* 1000 mcg/mL INJECTABLE, METHYLCOBALA...
Injectable Drugs·726 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
Sodium tetradecyl SO4, 3% injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Injectable Drugs·100 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
TESTOS CYPIONATE* IN OLIVE OIL 200 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Injectable Drugs·17 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
EDETATE DISODIUM* (0.05M) 1.7% OPHTH SOL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Drugs·30 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
Ceftazidime, 22.5 mg/ml (ophthalmic), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Ophthalmic Drugs·44 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
Cyanocobalamin, 1000 mcg/ml; injectable, all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Injectable Drugs·180 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
TRIPLE MIX* 15 mg/1 mg/20 mcg/mL INJECTABLE, TRIPLE MIX* 30 mg/1 mg/20 mcg/mL INJECTABLE (papaverine hydrochloride, phentolamine, prosta...
Injectable Drugs·44 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
FLUOROURACIL* PF 50 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Injectable Drugs·4 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
POTASSIUM PHOSPHATE* PF 4.4 MEQ (3MM)/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Injectable Drugs·600 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
DEXAMETHASONE NAPO4* PF 4MG/ML SOLUTION, all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Drugs·70 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
Aluminum Potassium Sulfate Sterile powder, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Drugs·160 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
Multitrace-4 pediatric injection ( zinc sulfate usp granular heptahydrate, cupric sulfate pentahydrate usp, manganese sulfate monohydrate...
Injectable Drugs·186 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
Sodium Thiosulfate PF, 10 % injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Injectable Drugs·180 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
VIGAMOX (moxifloxacin)* IN BSS (0.15 %) 0.75 mg/0.5 mL PREF SYRINGE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, ...
Drugs·204 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
Papav/Phentol/PG E1, 30 mg/1 mg/20 mcg/mL, injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI ...
Injectable Drugs·35 affected·Oct 19, 2013
CriticalFDA
Specialty Medicine Compounding Pharmacy, P.c.
Dextrose* Vial In Sterile Water, 50%, 50 mL Single Dose Vial, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Ly...
Drugs·1,000 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
SODIUM PHOSPHATE* PF 3MMOL/mL INJECTABLE, SODIUM PHOSPHATE* PF(15 mL) 3MMOL/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharma...
Injectable Drugs·9,200 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
Phenylephrine/Tropicamide 2.5 %/1 % ophthalmic solution, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, M...
Ophthalmic Drugs·6 affected·Oct 19, 2013
High RiskFDA
Specialty Medicine Compounding Pharmacy
LIDOCAINE/SODIUM CHL* 0.4 %/18 % INJECTABLE; all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI...
Injectable Drugs·65 affected·Oct 19, 2013