# FDA recall D-0854-2022

> **Viatris Inc** · Class II · drug recall initiated 2022-04-28.

## 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.

## Reason for recall

Failed Dissolution Specifications: low out of specification results for dissolution.

## Distribution

Product was distributed nationwide in the USA

## Key facts

- **Recall number:** D-0854-2022
- **Recalling firm:** Viatris Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-04-28
- **Report date:** 2022-05-18
- **Termination date:** 2023-07-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Canonsburg, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0854-2022

## Citation

> AI Analytics. FDA recall D-0854-2022. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-0854-2022. Source: US FDA. Licensed CC0.

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