Drug Recalls and Withdrawals

The Alliance is committed to providing quality care to our members, which is why we prioritize equipping providers with the most up to date drug information. Staying informed about company and FDA-issued drug recalls and withdrawals can help providers deliver quality care to our members.

What is a drug recall?

When a company issues a drug recall, they will stop making and selling their product because the drug may not be safe to take. A company can voluntarily decide to issue a recall, or the U.S. Food and Drug Administration (FDA) might request or order a recall.

What are the types of drug recalls?

Recalls are categorized based on the severity of risk they pose to consumers.

• Class I recall: This is the most serious type of recall. This is when a product is removed from the market because there is a high likelihood that it will cause serious adverse health outcomes or death.
• Class II recall: This recall occurs when a product is removed because it may cause temporary adverse health outcomes or where the likelihood of the serious health outcomes is small.
• Class III recall: When a product is not likely to cause serious health outcomes, a Class III recall is issued and the product is removed from the market.
• Market withdrawal: A market withdrawal happens when a product has a smaller problem that could be fixed and is not subject to FDA legal action. The company removes the product from the market to fix the issue. For example, a product may be removed from the market due to tampering with no evidence of there being a manufacturing or distribution problem.

Where can I learn more about recalls?

The FDA will often update its website with the latest news about drug recalls. You can also subscribe to get notifications about the latest recalls on the FDA’s website.
If your patient is taking a medication that has been recalled or if your patient thinks they may have been affected by a recall, please talk to them about what to do next.
In response to a recall, you may need to:

•  Give your patients a new prescription or recommend an alternative.
• Contact the manufacturer with any questions.
• Report adverse side effects (if any) to the FDA's MedWatch Adverse Event Reporting program.

Thank you for taking care of our community.