Pennsylvania-based pharmaceutical and health care corporation Viatris initially issued the recall March 17, and the recall was classified as a Class II recall on Apr. 8. Class II recalls indicate that the product may “cause temporary or medically reversible adverse health consequences,” according to the FDA’s website.
The medication was recalled due to “failed dissolution specifications,” according to the recall notice. Dissolution tests determine whether a drug is dissolving at the correct speed to release its active ingredient after users ingest it, according to the FDA.
A failed test could mean the drug may not maintain its intended effectiveness or dosage consistency.
The recall affects 3 mg, 60 tablet Xanax XR bottles distributed by Viatris. The affected medication is prescription-only.
The affected lot number is # 8177156 with an expiration date of 02/28/2027, according to the recall notice. The lot of Xanax was distributed nationwide between Aug. 27, 2024, and May 29, 2025, the California State Board of Pharmacy stated in a notice.
Xanax XR is a benzodiazepine used to treat panic disorder with or without agoraphobia in adults, according to the California State Board of Pharmacy.
Anyone who has been prescribed the affected pills should stop taking them immediately and dispose of them.