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  1. Office of Global Policy and Strategy

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:

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 FDA’s Office of Enforcement and Import Operations, Division of Enforcement via email at ORAHQROE@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: USFDAOIPRecallNotifications@fda.hhs.gov.

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