MedWatch: The FDA Safety Information and Adverse Event Reporting Program
Your FDA gateway for clinically important safety information and reporting serious problems with human medical products.
What's New
Losartan Potassium Tablets, USP and Losartan Potassium/Hydrochlorothiazide Tablets, USP by Torrent Pharmaceuticals - Recall: Due to Detection of Trace Amounts of an Unexpected Impurity intended for Patient, Health Professional, Pharmacy, Cardiology. [04/19/2019]
Test Strips for at Home Use: Safety Communication - Warning That Some Sellers are Marketing Pre-owned Test Strips or Test Strips Not Authorized for Sale in the United States intended for Consumer, Patient, Health Professional, Risk Manager. [04/08/2019]
E-cigarette: Safety Communication - Related to Seizures Reported Following E-cigarette Use, Particularly in Youth and Young Adults. [04/03/2019]
DG/Health NATURALS Baby Cough Syrup + Mucus by Kingston Pharma: Recall - Possible Health Risk intended for Consumer, Pediatrics, Pharmacy. [03/22/2019]
BLUEFUSION Capsules by Ata Int: Recall - Due to Presence of Undeclared Sildenafil, Tadalafil, Desmethyl Carbodenafil, Dithiodesmethyl Carbodenafil, Scutellarin and Daidzein intended for Consumer, Pharmacy, Urology. [03/22/2019]
Levoleucovorin Injection by Mylan Institutional: Recall - Due to the Presence of Particulate Matter intended for Health Professional, Risk Manager, Pharmacy. [03/19/2019]
Transseptal Needle by Cook Medical: Class I Recall - Due to Risk of Detached Plastic Fragments intended for Health Professional, Risk Manager. [03/18/2019]
8.4% Sodium Bicarbonate Injection by Hospira: Recall - Due to the Presence of Particulate Matter intended for Health Professional, Risk Manager, Pharmacy. [03/18/2019]
Losartan Potassium Tablets by Legacy Pharmaceutical Packaging (by Camber Pharmaceuticals and by Torrent Pharmaceuticals): Recall - Due to The Detection of Trace Amounts Of N-Nitroso N-Methyl 4-Amino Butyric Acid Impurity Found in The Active Pharmaceutical Ingredient intended for Patient, Health Professional, Pharmacy. [03/18/2019]
2019 Safety Alerts for Human Medical Products
March 2019
- Levoleucovorin Injection by Mylan Institutional: Recall - Due to the Presence of Particulate Matter intended for Health Professional, Risk Manager, Pharmacy. [03/19/2019]
- Transseptal Needle by Cook Medical: Class I Recall - Due to Risk of Detached Plastic Fragments intended for Health Professional, Risk Manager. [03/18/2019]
- 8.4% Sodium Bicarbonate Injection by Hospira: Recall - Due to the Presence of Particulate Matter intended for Health Professional, Risk Manager, Pharmacy. [03/18/2019]
- Losartan Potassium Tablets by Legacy Pharmaceutical Packaging (by Camber Pharmaceuticals and by Torrent Pharmaceuticals): Recall - Due to The Detection of Trace Amounts Of N-Nitroso N-Methyl 4-Amino Butyric Acid Impurity Found in The Active Pharmaceutical Ingredient intended for Patient, Health Professional, Pharmacy. [03/18/2019]
- Paclitaxel-Coated Balloons and Paclitaxel-Eluting Stents: Letter to Health Care Providers - Potential for Increased Long-term Mortality After Use intended for Cardiology, Risk Manager, Health Professional. [03/15/2019]
- Pilocarpine 0.1% Ophthalmic Solution by Stokes Healthcare: Recall - Due to a High Level of Preservative intended for Consumer, Eye Care, Health Professional. [03/14/2019]
- Valsartan Tablets USP, 160 mg by American Health Packaging: Recall - Due to Detection of N-Nitrosodiethylamine (NDEA) Impurity. [03/08/2019]
- LifeVest 4000 Wearable Cardioverter Defibrillator by Zoll: Safety Communication - Software Update intended for: Cardiology, Patient, Health Professional. [03/06/2019]
February 2019
Robotically-Assisted Surgical Devices: Safety Communication - Caution When Using in Women's Health including Mastectomy and Other Cancer-Related Surgeries intended for: Patient, Oncology, Surgery, Health Professional. [02/28/2019]
LIFEPAK15 by Physio-Control: Class I Recall - Due to Risk of Device "Lockup" (Freezing). [02/27/2019]
Xeljanz, Xeljanz XR (tofacitinib): Drug Safety Communication - Safety Trial Finds Increased Risk of Blood Clots in the Lungs and Death with Higher Dose in Rheumatoid Arthritis Patients intended for: Patient, Health Professional, Pharmacy, Rheumatology. [02/25/2019]
FDA Warns Thermography Should Not Be Used in Place of Mammography to Detect, Diagnose, or Screen for Breast Cancer intended for: Oncology, Radiology, Health Professional. [02/25/2019]
ChemoLock Vial Spike by ICU Medical: Class I Recall - Due to Risk of Detached Plastic Particles. [02/22/2019]
Uloric (febuxostat): Boxed Warning Added - Due to Increased Risk of Death with Gout Medicine intended for: Health Professional, Patient, Pharmacy. [02/21/2019]
Dual Chamber Implantable Pulse Generators by Medtronic: Recall - Due to Possible Circuit Error. [02/15/2019]
Breast Implants: Letter to Health Care Providers - Due to Associated-Anaplastic Large Cell Lymphoma. [02/07/2019]
Levetiracetam in 0.54% Sodium Chloride Injection 1500mg/100mL by Dr. Reddy's Laboratories: Recall - Due to Mislabeling. [02/05/2019]
Impella RP System by Abiomed: Letter to Health Care Providers - Increased Rate of Mortality intended for: Cardiology, Surgery, Transplantation. [02/04/2019]
Sterile Saline and Sterile Water for Inhalation by Medex Cardio-Pulmonary, Doing Business as Smiths Medical: Class I Recall - Due to Potential Exposure to Infectious Agents as a Result of Leaking Containers. [02/04/2019]
FDA Warns Compounders Not to Use Glutathione from Letco Medical to Compound Sterile Drugs Intended for: Pharmacy, Risk Manager. [02/01/2019]
LIFEPAK 15 Monitor/Defibrillator by Stryker: Recall - Due to Lock Up (blank monitor display with LED lights on) after a Defibrillation Shock is Delivered. [02/01/2019]
CoaguChek XS PT Test Strips by Roche Diagnostics: Recall - Due to Inaccurate Test Results. [02/01/2019]
Vial2Bag Fluid Transfer Systems by West Pharmaceutical Services: Recall - Due to Potential Malfunctions. [02/01/2019]
January 2019
Infants’ Ibuprofen Concentrated Oral Suspension by Tris Pharma: Recall - Due to Potential Higher Concentrations of Ibuprofen. [01/30/2019]
Silver Bullet 10x by Nature’s Rx: Recall - Due Undeclared PDF-5 Inhibitors in the Product. [01/29/2019]
VentStar and ID Breathing Circuits and Anesthesia Sets by Draeger Medical: Class I Recall - Due to a Risk of the Devices Being Incorrectly Assembled. [01/25/2019]
Losartan Potassium Tablets, USP and Losartan Potassium and Hydrochlorothiazide Tablets, USP by Torrent Pharmaceuticals: Recall Due to the Detection of N-nitrosodiethylamine (NDEA). [01/23/2019]
Paclitaxel-Coated Balloons and Paclitaxel-Eluting Stents Potentially Associated with Increased Mortality When Used for Treatment of Peripheral Arterial Disease - Letter to Health Care Providers. [01/17/2019]
Synergy Cranial Software and Stealth Station S7 Cranial Software by Medtronic: Recall - Due to Inaccuracies Displayed During Surgical Procedures. [01/08/2019]
FDA Approved Safety Information
DailyMed (National Library of Medicine)
Current Drug Prescribing Information. (NOTE: Drugs marked "unapproved" on this site have not been reviewed by FDA for safety and efficacy, and their labeling has not been approved.)Medication Guides
Paper handouts that come with many prescription medicines. Medication Guides address issues specific to particular drugs and drug classes. They contain FDA-approved information that can help patients avoid serious adverse events.Potential Signals of Serious Risks/New Safety Information Identified from the FDA Adverse Event Reporting System (FAERS) Postmarket Drug and Biologic Safety Evaluations
Evaluations performed 18 months after drug approval, or after its use by 10,000 individuals.