A drug recall occurs when a medication is removed from the market because it is found to be either defective or potentially harmful. The FDA along with pharmaceutical companies monitors medications out on the market for unforeseen problems. If an issue is identified, or the safety of the medication becomes a concern, a recall is initiated.

Information provided below are important new safety information regarding drug recalls. If you are taking a medication that has been recalled, please talk to your health care providers about the best course of action.

• 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.
• Market Withdrawal: occurs when a product has a minor violation that would not be subject to FDA legal action. The firm removes the product from the market or corrects the violation. 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 new 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

Market Withdrawal – April 4, 2024

• Relyvrio Oral Powder for Suspension (Sodium Phenylbutyrate – Taurusodiol) 3 GM/1 Packet 

Class I Recall - April 3, 2024

• Treprostinil Injection 20mg/20 mL

• Past drug recalls, alerts and market withdrawals