FDA US Enforcement
All recalls monitored by FDA are included in the Enforcement Report once they are classified. Information about how to navigate the report and for definitions of the report labels are found on the Enforcement Report Navigation and Definitions page.
For information gathered from press releases and other public notices about certain recalls of FDA-regulated products you can visit Recalls, Market Withdrawals, & Safety Alerts.
FDA is conducting two pilot programs to expedite notifications of Non-Blood (HCT/P, Vaccine, Derivative, etc.) and human drug product recalls to the public which can be found in the below links:
- Human Drug Product Recalls Pending Classification (also available by selecting “Pending Recalls”)
- Non-Blood Product On-Going Recalls
To subscribe to the enforcement report mailing list please follow this link: Enforcement Report email subscription.
Please e-mail enforcementreports@fda.hhs.gov with any comments.
An additional enforcement tool is the Import Alert, which informs FDA field staff and the public that the agency has enough evidence to allow for Detention Without Physical Examination (DWPE) of products that appear to be in violation of FDA laws and regulations. More information can be found at Import Alerts.
