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

• 2021 Biologics Recalls
• 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

Follow CBER

Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3103
Silver Spring, MD 20993-0002

ocod@fda.hhs.gov

(800) 835-4709
(240) 402-8010

For Updates on Twitter, follow @fdacber

• Resources for You (Biologics)
• About the Center for Biologics Evaluation and Research (CBER)
• Report a Problem to the Center for Biologics Evaluation & Research
• Recalls (Biologics)
• CBER-Regulated Products: Shortages and Discontinuations
• Biologics Products & Establishments