FDA and industry press releases regarding product recalls
- How to report adverse reactions or other problems with products the FDA regulates.
Find clinically important safety information and report serious problems with human medical products.
Navigate the Safety Section
FDA and industry press releases regarding product recallsMedWatch The FDA Safety Information and Adverse Event Reporting Program
Find clinically important safety information and report serious problems with human medical products.Report a Problem
Useful tools for consumers and health professionals to report problems (adverse reactions) with products that FDA regulates.
Product safety for food, drugs, devices, vaccines, color additives, cosmetics, animal/veterinary concerns, and online sales.Sentinel Initiative - Transforming How We Monitor Product Safety
A proactive system to augment the Agency's current surveillance capabilities for FDA-regulated products
Key Reports on FDA Safety Efforts
FDA's Safe Use Initiative: Collaborating to Reduce Preventable Harm from Medications(PDF - 915KB)
Report announcing FDA's Safe Use Initiative (November 2009)
Report on FDA's Approach to Medical Product Supply Chain Safety(PDF - 302KB)
FDA Report to Congress (July 2009)
Changing the Future of Drug Safety: FDA Initiatives to Strengthen and Transform the Drug Safety System(PDF - 773KB)
FDA Report to Congress and update on its Jan. 2007 response to the IOM report (July 2009)
The Future of Drug Safety - Promoting and Protecting the Health of the Public(PDF - 433KB)
FDA response to the IOM's 2006 report, done at FDA's request to evaluate the nation's drug safety system (January 2007)
Managing the Risks from Medical Product Use: Creating a Risk Management Framework
Report to the Commissioner from the FDA Risk Management Task Force (May 1999)