Vaccines, Blood & Biologics
Recalls are a firm's removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure. Recalls may be conducted on a firm's own initiative, by FDA request, or by FDA order under statutory authority.
Market Withdrawals are a firm's removal or correction of a distributed product which involves a minor violation that would not be subject to legal action by the FDA, or which involves no violation.
Recalls older than 5 years have been archived and can be obtained by placing a Freedom of Information (FOI) Request.
Recalls by Year
Recalls & Alerts
Approvals & Clearances
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Food and Drug Administration
10903 New Hampshire Avenue
Building 71 Room 3103Silver Spring, MD 20993-0002