Xanax XR Tablets (Viatris) – Dissolution Failure (2022)
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Viatris Inc
Lot Codes / Batch Numbers
Lot #: DX7983, exp. date 02/28/2023
Products Sold
Lot #: DX7983, exp. date 02/28/2023
Viatris Inc is recalling Xanax XR (alprazolam) extended-release tablets, 3 mg, 60-count bottle, Rx only, Distributed by Pharm due to Failed Dissolution Specifications: low out of specification results for dissolution.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Failed Dissolution Specifications: low out of specification results for dissolution.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026