The maker of Xanax is recalling a batch of the widely prescribed anxiety medication across the United States, according to a notice published by the Food and Drug Administration (FDA).
U.S.-based pharmaceutical company Viatris Inc. is recalling Xanax, or alprazolam, because it failed to meet dissolution specifications, says the FDA report uploaded to its website this week.
That means that a drug may not be able to deliver the correct dosage over time, which could impact how the medication is absorbed into the body, or that the consistency of the batch is compromised, the FDA says on its website.
The drug under recall is Xanax XR in extended-release tablets in 3-milligram doses in 60-tablet bottles, the FDA notice said. The drug, which was manufactured in Ireland, was distributed by Viatris Inc., based in Morgantown, West Virginia.
One lot of the medication is under recall. It has an expiration date of 02/28/2027 and an NDC number of 58151-506-91.
This lot of Xanax was distributed in the United States between Aug 27, 2024, and May 29, 2025, according to the California Board of Pharmacy in a separate notice.
“The risk to the patient associated with this event is considered to be negligible,” the board said, adding that the lot was recalled “out of an abundance of caution” after testing. “To date, no reports of adverse reactions associated with this lot have been received.”
The FDA classified the recall on April 8 as Class II, or what the federal regulator described as “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.”
No press release was issued for the action. The FDA said the recall is currently ongoing.
Alprazolam is classified as a benzodiazepine and is used to treat anxiety disorders and anxiety that is caused by depression. The medication is also used to treat panic disorders, says the California Board of Pharmacy.
The medication is commonly used. Drug database ClinCalc says it is the 37th most-prescribed medication in the United States, with more than 15 million prescriptions filled out with 3.2 million patients in 2023.
The National Institutes of Health (NIH) says it has a high propensity for misuse and addiction, with NIH officials in 2016 declaring alprazolam “abuse has reached epidemic levels and results in poor outcomes, particularly when combined with concomitant central nervous system depressants.”
The Epoch Times contacted Vitaris for comment on Thursday.