A nationwide recall has been issued for a specific lot of the widely prescribed anxiety medication Xanax after federal regulators identified a potential quality issue that could affect how the drug performs in patients.

According to the U.S. Food and Drug Administration, pharmaceutical company Viatris initiated a voluntary recall on Monday, March 17, 2025. The recall involves one lot of extended-release tablets that failed to meet required dissolution specifications, a standard that determines how a drug breaks down and releases its active ingredients in the body.

Health officials noted that when medications do not meet dissolution requirements, they may not deliver the intended dosage effectively. This could result in reduced therapeutic benefit or inconsistent drug release, which may impact patients relying on the medication for managing anxiety and panic disorders. The FDA classified the action as a Class II recall, indicating that temporary or medically reversible adverse health effects are possible.

The affected lot, identified as number 8177156, includes bottles containing 60 tablets of 3-milligram extended-release formulation. The products carry an expiration date of February 28, 2027, according to regulatory information.

Distribution records show the recalled medication was shipped nationwide between August 27, 2024, and May 29, 2025, reaching pharmacies across the United States. Officials have not disclosed the total number of bottles impacted by the recall.

Patients currently using this medication are advised to consult their healthcare providers or pharmacists if they have concerns about their prescriptions. Regulators continue to monitor the situation as part of ongoing efforts to ensure medication safety and effectiveness across the U.S. healthcare system.