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Safety & Drug Recall

A drug recall is when a medication is removed from the market because it is either defective or could be harmful. The FDA along with pharmaceutical companies monitormedications out on the market for unexpected problems. If an issue is identified, or the safety of the medication becomes a concern, a recall is started.

Below you will find information regarding drug recalls. If you are taking a medication that has been recalled, please talk to your health care providers about what to do.

  • Class I Recall: a situation in which there is a chance that the use of or exposure to a violative product will cause serious harmful health effects or death.
  • Class II Recall: a situation in which use of or exposure to a violative product may cause temporary or medically reversible harmful health effects or where the chance of serious harmful health effects is remote.
  • Class III Recall: a situation in which use of or exposure to a violative product is not likely to cause harmful health effects.
  • Market Withdrawal: occurs when a product has a minor harm that would not be subject to FDA legal action. The firm removes the product from the market or corrects the harm. For example, a product removed from the market due to tampering, without evidence of manufacturing or distribution problems, would be a market withdrawal.

The hyperlinks below contain important safety information regarding drug recalls. If you are taking a medication that has been recalled, please talk to your health care provider about the best course of action.

  1. Enforcement Reports | FDA
  2. Recalls, Market Withdrawals, & Safety Alerts | FDA
  3. MedWatch: The FDA Safety Information and Adverse Event Reporting Program | FDA
  4. Recalls (Biologics) | FDA