Resources for You
- Report a Serious Medical Product Problem Online
- Report Dietary Supplements and Tobacco Product Problems Online
Reporting Unlawful Sales of Medical Products on the Internet
- Consumer-Friendly Reporting Form 3500B (PDF - 1.2MB)
Current Drug Shortages Index Identifying Recalled Products Voluntary Adverse Event Reporting Contact Information MedWatch Partners
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.
DePuy Synthes Craniomaxillofacial Distraction System: Class I Recall - May Reverse Directions After Surgery Infants at highest risk for injury. Sudden obstruction of trachea could lead to respiratory arrest/death. In all patient populations, failure may result in need for surgical intervention to replace failed device. Posted 08/28/2014 CloverSnare 4-Loop Vascular Retrieval Snare by Cook Medical: Recall - Risk of Loop to Separate From Shaft UPDATED 08/27/2014. Lot numbers added. Originally posted 08/20/2014 Sterile Convenience Surgical Packs by Customed, Inc.: Recall - Potential Loss of Sterility Potential adhesion defect which may lead to infection. Posted 08/26/2014 Children’s Medical Ventures Gel-E Donut and Squishon 2: Class 1 Recall - Possibility of Mold Cladosporium and Penicillium Fungi which may cause difficulty in breathing, allergic reactions and serious health consequences, including death. Posted 08/22/2014
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.)
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) (formerly AERS) Postmarket Drug and Biologic Safety Evaluations
Evaluations performed 18 months after drug approval, or after its use by 10,000 individuals.