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
Nephron Pharmaceuticals Corp.
Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution, packaged in 30x3 mL Sterile Unit-Dose Vials, a) 30 count (NDC ...
Drugs·85,248 affected·Aug 21, 2015
CriticalFDA
Cantrell Drug Company
fentaNYL citrate in 0.9% Sodium Chloride Injection, 10 mcg/1 mL (10 mcg/mL), in 1 mL Syringe, Rx Only, Cantrell Drug Co., Little Rock, AR...
Injectable Drugs·884 affected·Aug 21, 2015
High RiskFDA
Cantrell Drug Company
MIDAZOLAM HCl in 0.9% Sodium Chloride Injection, 2 mg/2 mL (1 mg/mL), in 2 mL syringe, Rx only, Cantrell Drug Co., Little Rock, AR --- ND...
Injectable Drugs·1,570 affected·Aug 21, 2015
RecallFDA
Akorn, Inc.
Hydrocortisone and Acetic Acid Otic Solution, USP, containing hydrocortisone (1%) and acetic acid (2%), 10 mL bottles, Rx Only, Hi-Tech P...
Drugs·13,896 affected·Aug 21, 2015
High RiskFDA
Cantrell Drug Company
Midazolam HCl in 0.9% Sodium Chloride Injection, 0.5 mg/mL 1 mL (0.5 mg/mL), 1 mL syringes, Rx Only, Cantrell Drug Co., Little Rock AR --...
Injectable Drugs·3,853 affected·Aug 21, 2015
High RiskFDA
Cantrell Drug Company
LIDocaine HCl 1% BUFFERED WITH SODIUM BICARBONATE Injection, packaged in 3 mL Syringes, Rx Only, Cantrell Drug Co., Little Rock, AR --- U...
Injectable Drugs·450 affected·Aug 21, 2015
RecallFDA
Silarx Pharmaceutical, Inc.
Lamivudine Oral Solution, USP, 10 mg per 1 mL, 240 mL bottle (8 ounces), Rx only, Manufactured by: Silarx Pharmaceuticals, Inc. Carmel, N...
Oral Drugs·576 affected·Aug 21, 2015
CriticalFDA
Cantrell Drug Company
Atropine Sulfate Injection Solution, 0.4 mg/1 mL (0.4 mg/mL), in a) 1 mL syringes and b) 2 mL syringes, Rx Only, Cantrell Drug Co., Litt...
Injectable Drugs·450 affected·Aug 21, 2015
High RiskFDA
Cantrell Drug Company
HEParin Sodium 0.5 USP UNITS/mL in 0.225% SODIUM CHLORIDE, in 3 mL Syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- UPC: 9999992212
Drugs·352 affected·Aug 21, 2015
CriticalFDA
Cantrell Drug Company
fentaNYL Citrate 1 MCG/mL in 0.9% Sodium Chloride Injection, in 3 mL Syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- UPC: 999999...
Injectable Drugs·42 affected·Aug 21, 2015
High RiskFDA
Cantrell Drug Company
MIDAZolam HCl 0.1 mg/mL in 5% DEXTROSE 2.5 mL syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- UPC: 9999993721
Drugs·212 affected·Aug 21, 2015
CriticalFDA
Tipico Products Company, Inc.
Dry Grated Romano, Tipico Item #1-00111000, Net Wt. 50 lbs.
Food·2,000 affected·Aug 20, 2015
CriticalFDA
Mcf Operating Llc
Hellmann's Zesty Italian Dressing, One Gallon (128 fl oz) 3.70 L
Food·1,384 affected·Aug 20, 2015
High RiskFDA
Brett Anthony Foods
The product is in the form of a salad kit. It contains two plastic bags and one plastic container. The contents are; salad 3.7 lbs/bag, a...
Produce·0 affected·Aug 20, 2015
CriticalFDA
P East Trading Corporation
Salted Smoked Split Herring in bulk wooden boxes, Net Wt. 18 lbs., Product of Canada --- No label provided for bulk product.
Food·17 affected·Aug 20, 2015
CriticalFDA
Chetak New York, Llc
Deep All Natural Spices Coriander Powder, Net Wt 400g/14.1 oz Product of India, Distributed by: Chetak New York, L.L.C. Edison, NJ 08837 USA
Food·300 affected·Aug 20, 2015
High RiskFDA
Hospira Inc.
Ketamine Hydrochloride Injection, USP (100 mg/mL) packaged in 5 mL multi-dose glass fliptop vials, 10 vials per box, Rx only, Manufacture...
Injectable Drugs·83,320 affected·Aug 20, 2015
RecallFDA
Akorn, Inc.
RIFAMPIN FOR INJECTION USP, 600 mg*/vial, Rx Only. Mfd. for: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-151-42.
Injectable Drugs·6,861 affected·Aug 20, 2015
High RiskFDA
Orthovita, Inc., Dba Stryker Orthobiologics.
Aliquot Delivery Kit (Syringe and Plunger); for use in open and percutaneous procedures to facilitate placement of bone cement in weakene...
Medical Devices·9,805 affected·Aug 20, 2015
High RiskFDA
Pharmakon Pharmaceuticals
Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 0.0625 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKO...
Injectable Drugs·0 affected·Aug 19, 2015
High RiskFDA
Pharmakon Pharmaceuticals
Ketamine 50 mg/mL, injectable packed in syringes, Total dosage 50 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
Injectable Drugs·250 affected·Aug 19, 2015
High RiskFDA
Pharmakon Pharmaceuticals
Ephedrine Sulfate 5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 25 mg/ 5mL, Rx only, PHARMAKON Pharmaceuti...
Injectable Drugs·4,123 affected·Aug 19, 2015
High RiskFDA
Pharmakon Pharmaceuticals
Phenylephrine (PF) 100 mcg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 500 mcg/ 5mL, Rx only, PHARMAKON Pharm...
Injectable Drugs·0 affected·Aug 19, 2015
High RiskFDA
Pharmakon Pharmaceuticals
Ketamine 100 mg/mL, injectable packed in syringes, Total dosage 100 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
Injectable Drugs·600 affected·Aug 19, 2015
High RiskFDA
Pharmakon Pharmaceuticals
Midazolam (PF) 0.1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.2 mg/ 2mL, Rx only, PHARMAKON Pharmaceuti...
Injectable Drugs·665 affected·Aug 19, 2015
High RiskFDA
Pharmakon Pharmaceuticals
Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 4 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pha...
Injectable Drugs·0 affected·Aug 19, 2015
High RiskFDA
Pharmakon Pharmaceuticals
Rocuronium 10 mg/mL, injectable packed in syringes, Total dosage 50 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
Injectable Drugs·5,875 affected·Aug 19, 2015
High RiskFDA
Pharmakon Pharmaceuticals
Midazolam (PF) 0.5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.5 mg/ 1mL, Rx only, PHARMAKON Pharmaceuti...
Injectable Drugs·210 affected·Aug 19, 2015
High RiskFDA
Pharmakon Pharmaceuticals
Ondansetron 2 mg/mL, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.
Injectable Drugs·4,100 affected·Aug 19, 2015
High RiskFDA
Pharmakon Pharmaceuticals
Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 1 mg/ 1mL, Rx only, PHARMAKON Pharmaceutic...
Injectable Drugs·8,000 affected·Aug 19, 2015
High RiskFDA
Pharmakon Pharmaceuticals
Succinylcholine 20 mg/mL, injectable packed in syringes, Total dosage 100 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
Injectable Drugs·2,750 affected·Aug 19, 2015
High RiskFDA
Pharmakon Pharmaceuticals
Epinephrine (PF) 10 mcg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 50 mg/ 5mL, Rx only, PHARMAKON Pharmaceut...
Injectable Drugs·1,150 affected·Aug 19, 2015
High RiskFDA
Pharmakon Pharmaceuticals
Morphine Sulfate (PF) 0.5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.5 mg/ 1mL, Rx only, PHARMAKON Phar...
Injectable Drugs·475 affected·Aug 19, 2015
High RiskFDA
Pharmakon Pharmaceuticals
Fentanyl Citrate (PF) 50 mcg/mL, injectable packed in syringes a) Total dosage 250 mcg/ 5mL, b) Total dosage 100 mcg/ 2mL, Rx only, PHARM...
Injectable Drugs·7,100 affected·Aug 19, 2015
High RiskFDA
Pharmakon Pharmaceuticals
Lidocaine HCI (PF) Inj, USP 2%, injectable packed in syringes, Total dosage 100 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
Injectable Drugs·400 affected·Aug 19, 2015
High RiskFDA
Pharmakon Pharmaceuticals
Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 16 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Ph...
Injectable Drugs·378 affected·Aug 19, 2015
High RiskFDA
Pharmakon Pharmaceuticals
Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 0.25 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON ...
Injectable Drugs·0 affected·Aug 19, 2015
High RiskFDA
Pharmakon Pharmaceuticals
Midazolam 1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 2 mg/ 2mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
Injectable Drugs·5,000 affected·Aug 19, 2015
High RiskFDA
Pharmakon Pharmaceuticals
Glycopyrrolate 0.2 mg/mL, injectable packed in syringes, Total dosage 1 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
Injectable Drugs·1,530 affected·Aug 19, 2015
High RiskFDA
Pharmakon Pharmaceuticals
Morphine Sulfate (PF) 0.1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.1 mg/ 1mL, Rx only, PHARMAKON Phar...
Injectable Drugs·525 affected·Aug 19, 2015
High RiskFDA
Pharmakon Pharmaceuticals
Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 1 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pha...
Injectable Drugs·0 affected·Aug 19, 2015
CriticalFDA
Covidien Llc
MediTrace Cadence Adult Zoll, Preconnect Defibrillation Electrode, Nonsterile Item Code:22770PC
Cardiac Devices·114,000 affected·Aug 19, 2015
CriticalFDA
Covidien Llc
Physio-Control QuikCombo Pacing/Defibrillation/ECG Electrodes RediPak¿ Preconnect System Item Code:PM20022
Cardiac Devices·56,000 affected·Aug 19, 2015
High RiskFDA
Resource Optimization & Innovation Llc
Regard Custom Surgical Pack, Item Number: 800208002; Sterile, CV0361B - CABG A&B. Used in cardiovascular surgical procedures.
Surgical Devices·67 affected·Aug 19, 2015
CriticalFDA
Covidien Llc
MediTrace Cadence Adult Multi-Function Defibrillation Electrodes Item Code:22550PC
Cardiac Devices·7,660 affected·Aug 19, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc.
ACUSON SC2000 Ultrasound System with software versions VB10B and lower; Model 10433816; Product Usage: The SC2000 ultrasound imaging ...
Cardiac Devices·2,039 affected·Aug 19, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Force; computed tomography x-ray system. Intended to generate and process cross-sectional images of patients.
Medical Devices·21 affected·Aug 18, 2015
High RiskFDA
Medtronic Perfusion Systems
MEDTRONIC PERFUSION TUBING PACKS (with potentially affected Hemoconcentrators). Model # 7U65R2, 8C72R4, 6N21R2, BB7M38R11, TL2Q68R17, H...
Medical Devices·1,594 affected·Aug 18, 2015