Recalls and Shortages Branch
The Recalls and Shortages Branch within the Office of Drug Security, Integrity and Recalls/ Division of Import Operations and Recalls:
- Monitors, screens and evaluates incoming recall alerts to identify events that may pose a significant health risk that require immediate FDA response, including the need for press statements or other regulatory action.
- Evaluates and coordinates Health Hazard Evaluation (HHE) requests, and assigns classifications to recall actions initiated to remove violative and defective human drug products from the market.
- Serves as the coordinator between the Office of Compliance and the CDER Drug Shortage Staff to help avert drug shortages of medically necessary drugs.
A Recall is a firm's removal or correction of a marketed product that FDA considers to be in violation of the laws it administers, and against which the Agency would initiate legal action, such as a seizure. Recall does not include a market withdrawal. Recalls may be conducted on a firm's own initiative or, by FDA request. Recalls are classified by FDA with a numerical designation of I, II, or III to indicate the relative degree of health hazard presented by the product being recalled.
- 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.
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.
If you have a medicine that has been recalled, talk to your health care professional about the best course of action. Stores generally have a return and refund policy when a company has announced a recall of its products.
It is FDA's policy to help prevent or alleviate shortages primarily of medically necessary drug products, since these can have significant public health consequences. A drug shortage may involve either an actual or a potential shortage of a drug product. The Recalls and Shortages Branch serves as the liaison between the Office of Compliance and CDER's Drug Shortage Staff located within the Office of New Drugs to help address drug shortage situations.
Drug Shortages Links