The Recalls and Shortages Branch within the Office of Drug Security, Integrity and Response/ Division of Import Operations and Recalls:
- Class I recall: a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
- Class II recall: a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
- Class III recall: a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
A Market Withdrawal is a firm's removal or correction of a distributed product that involves a minor violation that would not be subject to legal action by FDA or that involves no violation. Market Withdrawals are not considered to be Recalls. For example, a product removed from the market due to tampering, without evidence of manufacturing or distribution problems, would be a market withdrawal.
- FDA 101: Product Recalls (video)
- Follow FDA Recalls on Twitter
- Product Recalls Mobile Phone App
- Index to Drug-Specific Information
- Chapter 7 - Recall Procedures
- 21CFR7 Subpart C--Recalls (Including Product Corrections)--Guidance on Policy, Procedures, and Industry Responsibilities
- Pill Identification
In July 2011, FDA began a pilot program to notify people of drug recalls before they are classified. These unclassified recalls will be published in the FDA Enforcement Report every Wednesday and will be listed under the heading, "Recalls Pending Classification: DRUGS." They will be reposted with their classification once that determination has been made. Send comments or suggestions to RecallPilot@fda.hhs.gov.