A specific lot of the widely prescribed anti-anxiety drug Xanax has been recalled nationwide for not passing quality control tests concerning the time the pills take to dissolve, according to the Food and Drug Administration.
Prescription-only, 3-milligram pills of Xanax XR in bottles of 60 tablets made in Ireland have been voluntarily recalled by West Virginia-based distributor Viatris Specialty LLC, according to a notice posted by the FDA on April 15.
The recall was issued because the pills “failed dissolution specifications,” according to the FDA. A notice issued by the California State Board of Pharmacy said the recall is a result of “out-of-specification dissolution results.”
Xanax XR is a benzodiazepine used to treat panic disorder with or without agoraphobia in adults, according to the California State Board of Pharmacy.
Dissolution tests determine if a drug is dissolving at the correct speed to release its active ingredient after it’s ingested, according to the FDA. Failing the tests could mean the drug may not maintain its intended effectiveness or dosage consistency.
The FDA designated the recall as Class II, which is “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,” according to the agency.
The recall applies to pills with the lot number 8177156 and an expiration date of Feb. 28, 2027. The lot was distributed between Aug. 27, 2024, and May 29, 2025, according to the California State Board of Pharmacy notice.
Anyone who has the affected pills should stop taking them immediately and dispose of them.