Why is Xanax XR being recalled nationwide?

Xanax XR 3mg tablets are being recalled nationwide because a specific lot, #8177156, failed dissolution specifications during quality control testing.

What is a Class II recall by the FDA?

A Class II recall, as designated by the FDA for the Xanax XR recall, means that use of or exposure to the violative product may cause temporary or medically reversible adverse health consequences.

Which specific Xanax XR product is affected by the recall?

The recall affects lot #8177156 of Xanax XR, alprazolam, extended-release tablets in 3 mg strength, provided in 60-tablet bottles, with an expiration date of February 28, 2027.

Home / Health / Xanax Recall: Critical Dissolution Failure

Xanax Recall: Critical Dissolution Failure

15 Apr

•

Summary

A specific lot of Xanax XR 3mg tablets recalled.
Recall due to failure in dissolution quality control tests.
FDA classified the event as a Class II recall.

Xanax Recall: Critical Dissolution Failure

A nationwide recall has been issued for a specific lot of Xanax XR, the popular medication for anxiety and panic disorders. The recall, initiated by pharmaceutical company Viatris Inc., affects lot #8177156 of the 3mg extended-release tablets in 60-tablet bottles, which expire on February 28, 2027.

The U.S. Food and Drug Administration (FDA) has classified this recall as Class II. This designation indicates that exposure to the recalled product may cause temporary or medically reversible adverse health effects. The primary reason for the recall is the drug's failure to meet dissolution specifications during quality control testing.