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.

Recalls older than 2 years are available on FDA Archive.

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Recalls by Year

• 2019 Biologics Recalls
• 2018 Biologics Recalls
• 2017 Biologics Recalls - ARCHIVED
• 2016 Biologics Recalls - ARCHIVED
• 2015 Biologics Recalls - ARCHIVED
• 2014 Biologics Recalls - ARCHIVED

CBER Recall Postings

• CBER FY 2019 Recall Postings
• CBER FY 2018 Recall Postings

Related Information

• Direct Recall Classification Program
• Enforcement Reports

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Food and Drug Administration
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Food and Drug Administration

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The latest information from the Center for Biologics Evaluation and Research.