Sept. 24, 2026

The U.S. Food and Drug Administration’s MedWatch program has two goals: 

• To alert providers about product recalls, safety labeling changes and new risks  

• To allow providers to report adverse events or quality concerns directly to the FDA  

You are uniquely positioned to observe and act on emerging safety concerns for your patients. 

The data MedWatch collects can help:  

• Promote early awareness about medication recalls, safety labeling changes and newly identified relevant adverse events 

• Provide a reliable resource to support patient counseling 

• Support clinical decision-making by integrating real-world safety data 

• Empower you and your patients to act on patient-reported adverse events and contribute to national pharmacovigilance, identifying trends that may lead to FDA actions such as black box warnings, risk evaluation and mitigation strategies or product withdrawals 

• Simplify safety monitoring and strengthen collaboration among providers in reporting and responding to drug safety concerns 

Alerts and reporting 

• Sign up for alerts at MedWatch: The FDA Safety Information and Adverse Event Reporting Program. 

• Submit reports via the MedWatch Online Voluntary Reporting Form for unexpected side effects, suspected medication errors, product defects, packaging concerns and patient complaints about unexpected adverse reactions. 

• Use the Vaccine Adverse Event Reporting System to report any issues with vaccines.