Agency classClass IIOur severity:High FDA (Drugs)·D-0854-2022·Announced 2022-05-18

Xanax XR Extended-Release Tablets Recalled for Failed Dissolution Specifications

Viatris Inc recalls Xanax XR (alprazolam) 3 mg extended-release tablets due to failed dissolution specifications. Affected tablets may not break down properly, potentially reducing medication effectiveness.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 involving a quality control failure that affects drug efficacy. The source reports no illnesses or injuries, and the hazard—failed dissolution specifications—represents a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Viatris Inc is recalling Xanax XR (alprazolam) extended-release tablets, 3 mg, in 60-count bottles. The recall affects 110 bottles distributed nationwide in the United States under NDC 0009-0068-07, lot DX7983 with an expiration date of 02/28/2023. The tablets failed to meet dissolution specifications required by quality control standards.

Dissolution specifications ensure that extended-release tablets break down properly in the digestive tract to release medication gradually as designed. Tablets that fail these standards may not work as intended, potentially affecting treatment effectiveness and drug absorption.

Consumers who have purchased Xanax XR tablets from lot DX7983 should contact their pharmacist or healthcare provider immediately. They should not use the recalled product and should follow their healthcare provider's guidance regarding continued treatment.

The recalled product

Product: Xanax XR (alprazolam) extended-release tablets, 3 mg, 60-count bottle, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Fizer Inc, NY, NY 10017, NDC 0009-0068-07.
Manufacturer: Viatris Inc
Category: Drug
Hazard: failed-dissolution
reduced-bioavailability
Affected units: 110

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 #: DX7983
exp. date 02/28/2023

Distribution

Distributed nationwide across the United States.

Same manufacturer · Viatris Inc

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