The Recall Desk
HighFDA (Drugs)·D-0444-2026·Announced 2026-04-15

Xanax XR 3 mg extended-release tablets fail dissolution specifications

Viatris is recalling one lot of Xanax XR (alprazolam) extended-release tablets, 3 mg, after the product failed dissolution specifications.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall for a failed dissolution specification, which can alter the rate of drug release and creates a risk of harm with no injuries reported.

Plain-English summary

Viatris, Inc. is recalling Xanax XR (alprazolam) extended-release tablets, 3 mg, supplied in bottles of 60 tablets, NDC 58151-506-91.

The stated reason is failed dissolution specifications. Dissolution testing measures how a tablet releases its active ingredient, and an extended-release formulation that falls outside specification may not deliver the drug at the intended rate. The FDA classified the action as Class II.

The affected lot is 8177156, expiry 02/28/2027. Distribution was US nationwide.

This is a prescription medicine. Patients should not stop taking a prescribed benzodiazepine without medical advice; anyone holding the affected lot should contact their pharmacy or prescriber about a replacement supply.

The recalled product

Product
XANAX (ALPRAZOLAM)
Brand
XANAX
Manufacturer
Viatris, Inc.
Category
Drug — Extended-release tablet
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot# 8177156
  • Exp Date: 02/28/2027

UPCs (4)

  • 0358151506910
  • 0358151504916
  • 0358151503919
  • 0358151505913

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · XANAX

Same manufacturer · Viatris, Inc.

See all →

Same hazard · failed dissolution

See all →