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A batch of Xanax XR is being recalled nationwide after the manufacturer found it may not release the medication in the body as intended.
Viatris, Inc. initiated the voluntary recall for ALPRAZolam extended-release tablets, 3 mg, distributed in 60-count bottles under lot number 8177156 with an expiration date of Feb. 28, 2027, according to the U.S. Food and Drug Administration.
Xanax XR is a benzodiazepine used to treat panic disorder and anxiety in adults.
The issue was classified as a Class II recall, meaning it may cause temporary or medically reversible health effects but is unlikely to result in serious harm.
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A pharmacy tech pulls medication from a shelf inside a pharmacy in Provo, Utah on Thursday, Aug. 7, 2025. (George Frey/Bloomberg via Getty Images / Getty Images)
“Failed dissolution specifications” indicate the tablets may not dissolve and release the medication at the intended rate. Because Xanax XR is designed to release gradually over time, any variation could affect how the drug is delivered in the body — and how well it works.
The affected product was distributed nationwide in the United States, though the recall applies only to the specific lot identified. The FDA lists the recall as ongoing, with no termination date yet announced.
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In this photo illustration, the Viatris Inc. logo is seen displayed on a smartphone screen. (Rafael Henrique/SOPA Images/LightRocket via Getty Images)
A spokesperson for Viatris told FOX Business the recall is limited in scope and does not pose a significant risk to patients.
“The voluntary recall of Xanax XR in the U.S. is specific to one lot of one strength (3mg) of the brand product only, and 51 bottles were distributed to U.S. wholesalers between Aug. 27, 2024, and May 29, 2025,” the spokesperson said. “No other batches of the Xanax XR brand product, or its generics, are impacted.”
A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020, in White Oak, Maryland. (Sarah Silbiger/Getty Images)
The spokesperson added that most patients in the U.S. are prescribed generic ALPRAZolam, which is not affected by the recall.
“The risk to the patient associated with this event is considered to be negligible. To date, no reports of adverse reactions associated with this lot have been received,” the spokesperson said.
Viatris said the recall is being conducted at the retail level, meaning pharmacies and wholesalers have been instructed to return the affected product.
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“Patients do not need to take any action,” the spokesperson said.
