FDA Recall Regulations

This information collection supports FDA regulations governing recalls. The information collection provisions apply to all regulated products (i.e., food, including animal feed; drugs, including animal drugs; medical devices, including in vitro diagnostic products; cosmetics; biological products intended for human use; and tobacco). Respondents to the collection are those who introduce FDA-regulated products into interstate commerce or who are otherwise subject to the applicable regulations.

The latest form for FDA Recall Regulations expires 2027-06-30 and can be found here.

Firm Initiated Recall and Recall Communications

Federal Enterprise Architecture: Health - Public Health Monitoring