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A batch of Xanax XR is being recalled nationwide after the producer discovered it could not launch the treatment within the physique as supposed.
Viatris, Inc. initiated the voluntary recall for ALPRAZolam extended-release tablets, 3 mg, distributed in 60-count bottles below lot quantity 8177156 with an expiration date of Feb. 28, 2027, in response to the U.S. Meals and Drug Administration.
Xanax XR is a benzodiazepine used to deal with panic dysfunction and nervousness in adults.
The problem was labeled as a Class II recall, which means it could trigger short-term or medically reversible well being results however is unlikely to lead to severe hurt.
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A pharmacy tech pulls treatment from a shelf inside a pharmacy in Provo, Utah on Thursday, Aug. 7, 2025. (George Frey/Bloomberg by way of Getty Photos / Getty Photos)
“Failed dissolution specs” point out the tablets could not dissolve and launch the treatment on the supposed price. As a result of Xanax XR is designed to launch steadily over time, any variation might have an effect on how the drug is delivered within the physique — and the way nicely it really works.
The affected product was distributed nationwide in the USA, although the recall applies solely to the precise lot recognized. The FDA lists the recall as ongoing, with no termination date but introduced.
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On this photograph illustration, the Viatris Inc. brand is seen displayed on a smartphone display screen. (Rafael Henrique/SOPA Photos/LightRocket by way of Getty Photos)
A spokesperson for Viatris advised FOX Enterprise the recall is restricted in scope and doesn’t pose a major danger to sufferers.
“The voluntary recall of Xanax XR within the U.S. is restricted to 1 lot of 1 power (3mg) of the model product solely, and 51 bottles had been distributed to U.S. wholesalers between Aug. 27, 2024, and Could 29, 2025,” the spokesperson stated. “No different batches of the Xanax XR model product, or its generics, are impacted.”
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An indication for the Meals And Drug Administration is seen outdoors of the headquarters on July 20, 2020, in White Oak, Maryland. (Sarah Silbiger/Getty Photos)
The spokesperson added that the majority sufferers within the U.S. are prescribed generic ALPRAZolam, which isn’t affected by the recall.
“The danger to the affected person related to this occasion is taken into account to be negligible. To this point, no experiences of hostile reactions related to this lot have been obtained,” the spokesperson stated.
Viatris stated the recall is being carried out on the retail stage, which means pharmacies and wholesalers have been instructed to return the affected product.
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“Sufferers don’t have to take any motion,” the spokesperson stated.
