Recalls (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.

The most recent action is added to the top of the list. Dates refer to the effective date of the recall, withdrawal, correction, or notification.

Recalls older than 5 years have been archived and can be obtained by placing a Freedom of Information (FOI) Request.