FDA Recalls, Market Withdrawals & Safety Information
To obtain the most current information on U.S. recalls of FDA-regulated products, FDA regulators are encouraged to monitor FDA’s web page at https://www.fda.gov/Safety/Recalls/default.htm. This page also contains information that FDA gathers from company press releases and other public notices about certain recalls of FDA-regulated products.
Regulators can also visit the following links for more safety information by specific product area:
- Drugs: For a list of Alerts for Human Medical Products, see MedWatch Safety Alerts for Human Medical Products. Also see FDA’s MedWatch, for the FDA Safety Information and Adverse Event Reporting System.
- Animal Health: For additional safety information about products affecting animal health, see FDA’s Animal & Veterinary Recalls & Withdrawals.
- Biologics: For Biologic Recalls and Market Withdrawal information, see FDA's Recalls (Biologics).
- Cosmetics: For additional safety information about cosmetic products, see FDA's Cosmetics Recalls and Alerts.
- Foods: For updates on FDA foodborne illness outbreak investigations, go to Outbreaks: Investigation, Response & Evaluation. You may also go to Major Product Recalls.
For food recalls, go to Recalls, Market Withdrawals, & Safety Alerts.
- Medical Devices: For a more complete listing of Medical Device Recalls, see FDA’s Medical Device Recalls.
FDA also provides contact information where regulators may report FDA-regulated recalled products that have been exported from their country to the USA. The foreign authority may report to the Recall Operations Branch in the FDA’s Office of Policy, Compliance, and Enforcement via email at ORARECALLOE@fda.hhs.gov. This contact information can also be shared with the firms located in your country. When reporting, indicate whether FDA should work directly with the firm, in which case contact information will be needed, or with the authority to obtain additional information. The following initial information should be provided:
- Reason for recall
- Product description and codes
- Product labeling
- If known, the list of U.S. consignees who received the recalled product
- Point of contact information
Questions? Please send them to: USFDAGlobalRecallNotifications@fda.hhs.gov.