FDA Issues Nationwide Recall of Xanax Due to Dissolution Concerns
The Food and Drug Administration (FDA) has announced a nationwide recall of select lots of Xanax, a widely used anti-anxiety medication. The recall, initiated by the distributor Viatris, is due to 'failed dissolution specifications,' meaning the tablets may not dissolve properly in the body. This could lead to either lower-than-expected drug absorption or a faster-than-expected release, potentially reducing the therapeutic effect. The recall is classified as Class II, indicating that the product may cause temporary or medically reversible adverse health consequences. The specific lot affected is 3-milligram tablets of Xanax XR, sold in 60-tablet bottles, with the lot number 8177156 and an expiration date of February 28, 2027. The lot was distributed in the U.S. between August 27, 2024, and May 29, 2025. No adverse reactions have been reported so far.