How Foreign Regulators and Stakeholders Can Receive Notifications of Recalled FDA-Regulated Products

The U.S. Food and Drug Administration (FDA) understands that foreign regulators and stakeholders are interested in receiving alerts about recalls involving FDA-regulated products. There are several ways to stay informed about FDA recalls. The Agency posts this information on its Recalls, Market Withdrawals, and Safety Alerts and Major Product Recalls web pages and offers a subscription service to receive notifications of all recalls, or recalls by commodity, via the FDA Enforcement Report.

For product-specific safety information and to sign up for commodity-specific email notifications, visit the following links:

• Drug Recalls: For recall-related information on drug products, see Drug Recalls.
• Animal Health Products: For safety information on products affecting animal health, see Animal & Veterinary Recalls & Withdrawals.
• Biological Products (Biologics): For recall and market withdrawal information for biologics, see Recalls (Biologics).
• Cosmetics: For safety information on cosmetic products, see Cosmetics Recalls and Alerts.
• Foods: For updates on FDA foodborne illness outbreak investigations, see Outbreaks of Foodborne Illness.  Food recall information can be accessed via the Recalls, Market Withdrawals, & Safety Alerts.
• Medical Devices: For a listing of medical device recalls, see Medical Device Recalls.
• MedWatch: the FDA Safety Information and Adverse Event Reporting Program: To subscribe to safety alerts from MedWatch, FDA’s medical product safety reporting program for health professionals, patients, and consumers, see FDA’s MedWatch.

To report FDA-regulated recalled products that have been exported from your country to the United States, foreign authorities should contact the Recall Operations Branch in the FDA’s Office of Policy, Compliance, and Enforcement at ORARECALLOE@FDA.HHS.GOV. This email address can also be shared with the firms in your country, although the various products might have different notification requirements.

The foreign authority should provide the following information: 

• Whether the FDA should work directly with the foreign firm, the importing firm (provide contact information), or the reporting authority from your country.
• Whether a federally recognized Tribe is involved and whether the firm is on tribal land and owned by the Tribe or a tribal member; email the Intergovernmental Affairs Staff within the Office of Policy, Legislation, and International Affairs at IGA@fda.hhs.gov.
• Reason for recall, including results from any laboratory analyses conducted.
• Product description and codes.
• Product label information, with clear images.
• List of U.S. consignees who received the recalled product (including address and telephone number), if known.
• Quantity distributed.
• Firm’s health hazard assessment, if available.
• Point of contact information for the recalling firm.

This information will help the FDA connect the foreign authority or firm to the division overseeing the recall. Additional information will be requested once this connection is established.

If you have any recall-related questions that are not addressed by the previous links, please email the FDA directly at: USFDAGlobalRecallNotifications@fda.hhs.gov.