One lot of Xanax XR extended-release tablets has been recalled nationwide by distributor Viatris after the drug failed to meet dissolution specifications, the Food and Drug Administration said.
The recall covers lot number 8177156 — 60-tablet bottles of 3mg extended-release tablets with an expiration date of Feb. 28, 2027. A Class II designation was assigned to the recall, which Viatris initiated on March 17 — a classification reserved for situations in which the probability of serious harm is considered remote, or in which any adverse health consequences would be temporary and medically reversible.
When a drug fails to meet dissolution specifications, NBC Chicago reports, health officials say the concern is that patients may receive an inconsistent or insufficient dose.
Distribution of the affected bottles spanned from Aug. 27, 2024, through May 29, 2025, the California State Board of Pharmacy said. The Board has directed patients holding the recalled lot to discontinue use and is calling on pharmacies to examine their recall procedures and quality assurance protocols to assess whether any corrective steps are warranted.
As of publication, Newsweek reports that patients have not reported any adverse reactions tied to the lot, and Viatris has yet to comment publicly on the matter. The total number of bottles swept up in the recall remains unknown.
Xanax is the brand name for alprazolam, a benzodiazepine used to treat anxiety and panic disorders. Newsweek says about 3.6 million people in the U.S. have prescriptions for it.
The FDA classifies recalls by how serious they are. Class I is the most severe and involves products that could cause death or serious harm. Class III is the least severe and covers products unlikely to cause health issues. This recall is Class II, which falls in between.