A drug recall may be conducted on a company’s own initiative or by FDA request. FDA’s role in a recall is to oversee a company’s recall strategy, assess the adequacy of the company’s action and classify the recall.
Visit recalls background and definitions page to learn about recall classifications.
Alerting the Public
Not all recalls are announced on FDA.gov or in the news media. Public notification is generally issued when a product that has been widely distributed or poses a serious health hazard is recalled. However, if a company does not issue public notification of a recall, FDA may do so if the agency determines it is necessary to protect patients and consumers. Patients and consumers also may learn that their medicine has been recalled through notification from the manufacturer, their doctor or pharmacist.
FDA recommends patients talk to their health care professional about the best course of action for their health if they have a medication that has been recalled.
Additionally, a company may suggest a patient or consumer return the product to the store in which they purchased it.
Stores generally have a return and refund policy when a company announces a product recall. Generally, Class I recall notifications provide instructions with actions for patients. FDA recommends that patients follow the instructions provided by the recalling company.
All recalls are posted weekly in the FDA enforcement report. Recalls that are classified will have a classification of Class I, Class II or Class III based on the level of hazard to patients. Recalls that have not been classified are included in the enforcement report as “not yet classified,” which is updated once a classification has been determined.
Determining the Effectiveness of the Recall
FDA evaluates the effectiveness of a recall by reviewing a company’s efforts to properly notify customers and remove the defective product from the market. If a recall is determined to be ineffective FDA will request the company take additional actions to protect patient health.
- Recalls, Market Withdrawals, & Safety Alerts
- MedWatch: The FDA Safety Information and Adverse Event Reporting Program
- Drug alerts and statements
- FDA Recall Coordinators
- Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C
- The Key Elements of Being "Recall-Ready"
- Best Practices for Drug Product Recalls [External Link Disclaimer]
- Additional recall-related guidance documents