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.

FDA recall notice · announced May 18, 2022 · Viatris

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: Product was distributed nationwide in the USA
Lot/code information: Lot #: DX7983, exp. date 02/28/2023
Quantity: 110 bottles
Status: Terminated
Products in this recall event:
- 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. (D-0854-2022)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.