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.
Bo Ying Compound by Eu Yan Sang (Hong Kong) Ltd: FDA/CDER Statement - Risk of Lead Poisoning Exposure to lead can cause serious damage to the central nervous system, the kidneys, and the immune system. Posted 09/26/2014 Xolair (omalizumab): Drug Safety Communication - Slightly Elevated Risk of Cardiovascular and Cerebrovascular Serious Adverse Events FDA approves label changes after review of a five year safety study. Posted 09/26/2014 Potassium Chloride Injection (Baxter): Recall - Shipping Carton Mislabeling Potential risk of medication error or delay in therapy for patients that require high concentration potassium chloride. Posted 09/17/2014 Playtex Nurser Deluxe Double Electric Breast Pump: Recall - Potential for Electric Shock UPDATED 09/16/2014. One AC/DC power adapter production lot added to recall. Originally posted 03/19/2014 August 2014 Safety Labeling Changes includes 32 products with revisions to Prescribing Information. Heparin Sodium, 1,000 USP Heparin Units/500 mL (2 USP Heparin Units/mL), In 0.9 percent Sodium Chloride Injection, 500 mL by Hospira: Recall - Particulate Matter Risk of injected particulate material which may result in local inflammation, phlebitis, and/or low-level allergic response. Posted 09/12/2014 Sterile Drug Products by Downing Labs (aka NuVision Pharmacy): Drug Alert - Lack of Sterility Assurance UPDATED 09/09/2014. FDA has issued a formal request to Downing Labs for the immediate recall of all lots of its purportedly sterile products currently on the market that are not expired. Originally Posted 07/19/2014
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) Postmarket Drug and Biologic Safety Evaluations
Evaluations performed 18 months after drug approval, or after its use by 10,000 individuals.