FDA RECALL: Nationwide Recall for Xanax XR 3 mg Tablets

Viatris issues Class II recall after extended‑release tablets fail dissolution testing.

FDA Nationwide Recall — Issued for a specific lot of Xanax XR (alprazolam) 3 mg extended‑release tablets, according to the U.S. Food and Drug Administration’s Enforcement Reports. The manufacturer, Viatris, initiated the recall after the product failed dissolution specifications, meaning the tablets may not break down properly in the body.

The recall is classified as Class II, indicating the defect may cause temporary or medically reversible adverse health consequences. The FDA advises patients not to stop taking alprazolam abruptly without medical guidance due to the risk of withdrawal.

Recalled Product Information
– Product: Xanax XR (alprazolam)
– Strength: 3 mg
– Form: Extended‑release tablets
– Bottle size: 60‑count
– Lot number: 8177156
– Expiration date: February 28, 2027
– Distribution: Nationwide
– Reason: Failed dissolution testing

Patients and providers with questions may contact Viatris Customer Relations at 800.796.9526 or customer.service@viatris.com

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