FDA alerts

See the following links for alerts, announcements and safety recalls from the U.S. Food and Drug Administration.

MedWatch safety alerts for human medical products
Provide timely new safety information on human drugs, medical devices, vaccines and other biologics, dietary supplements and cosmetics

FDA drug information
Index of FDA-approved drugs

Index to drug-specific information
List that only includes drugs that have been the subject of a Drug Safety Communication, Healthcare Professional Information Sheet, Early Communication About an Ongoing Safety Review or other important information; use FDA Drug Information to find information on all FDA-approved drugs

Recalls, market withdrawals and safety alerts
List of recalls, alerts and warnings of foods, drugs, medical devices and cosmetics

FDA drug alerts and statements
Information on drug safety and availability for consumers and health professionals, new drug warnings and other safety information, drug label changes and shortages of medically necessary drug products

Safety alerts and advisories
FDA alerts for consumers and health care professionals

FDA device alerts
Problems with medical devices may be caused when devices malfunction. But problems also may arise when users (either health professionals or the general public) do not understand or follow proper use instructions. The FDA issues alerts and warnings to explain why problems may be occurring and to clarify proper procedures to ensure safe and effective use of devices.

Postmarket drug safety information for patients and providers
Links to safety sheets with the latest risk information about particular drugs, related press announcements and other fact sheets

Contact us

Lauren Wallace, MS, RAC-Drugs
Director of clinical research regulatory affairs

Brendan Baggot
Clinical research monitor
FDA program administrator

Regulatory affairs