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The U.S. Food and Drug Administration (FDA) announced this Wednesday a voluntary nationwide recall of a specific batch of Xanax XR, the popular extended-release anxiolytic, for failing to meet the required quality standards.
The recall was initiated voluntarily by Viatris Specialty, a company based in West Virginia and the current manufacturer of the product.
The decision exclusively affects batch number 8177156, corresponding to three-milligram tablets in bottles of 60 pills, with an expiration date of February 28, 2027.
According to the official statement, the medication was recalled because it did not meet the dissolution specifications, meaning that the tablets do not dissolve at the required standard rate and the product may not have passed quality control tests.
The affected lot was distributed throughout the territory of United States between August 27, 2024 and May 29, 2025.
The formal withdrawal process began on April 8, although Viatris initiated the voluntary process in late March.
The FDA classified the product as Class II, which indicates that it may cause temporary or medically reversible adverse health effects, but does not pose an immediate serious or fatal risk.
As of the date of the announcement, no illnesses or injuries associated with the recalled lot have been reported.
The recall is highly specific and does not affect any other lot of Xanax XR or the generic Alprazolam, which represent the vast majority sold in the country.
A spokesperson for Viatris was clear on the matter: "The of a single strength of the branded product, and no other lot of Xanax XR or its generics are affected."
Both Viatris and the FDA agree that patients who have consumed the affected lot do not need to take any immediate action.
The FDA also warned that "in some cases, discontinuing a medication can be more harmful to health than continuing to take the recalled medication."
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