Xanax XR Tablets Recalled for Dissolution Failure

The US Food and Drug Administration (FDA) has classified a Class II recall for Xanax XR (alprazolam extended-release) tablets, 3 mg, packaged in 60-tablet bottles (NDC 58151-506-91). The product was manufactured in Ireland and distributed by Viatris Specialty LLC, Morgantown, WV. The recall applies to Lot #8177156, with an expiration date of February 28, 2027, and was initiated on March 17, 2026. The affected product was distributed nationwide in the US.

The recall was prompted by failed dissolution specifications, meaning the extended-release tablets did not meet required standards for drug release during quality testing. The FDA classified the recall as Class II on April 8, 2026, indicating that use of the affected product may result in temporary or medically reversible adverse health consequences, though serious harm is unlikely. In extended-release formulations, improper dissolution may lead to inconsistent absorption and variable therapeutic effect. Viatris notified consignees via letter; no public press release has been issued.

Xanax XR (alprazolam extended-release) is a benzodiazepine indicated for the treatment of panic disorder, with or without agoraphobia. As an extended-release formulation, consistent dissolution is essential to maintain stable plasma concentrations and symptom control. Pharmacists should identify and quarantine affected Lot #8177156, ensure removal from inventory, and coordinate with prescribers to provide unaffected supply. Patients should not abruptly discontinue benzodiazepine therapy due to the risk of withdrawal and should be managed under clinical supervision.

Reference

FDA. Enforcement Report. April 8, 2026. Accessed April 9, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm