The anti-anxiety drug Xanax has been urgently recalled over fears it may not work as effectively as intended.
Pennsylvania-based Viatris, Inc., voluntarily recalled its 60-tablet bottles of Xanax due to ‘failed dissolution specifications,’ meaning they may not dissolve correctly and release their active ingredient at the expected rate.
This could mean someone taking Xanax, one of America’s most popular anti-anxiety drugs, may receive too much or too little of the medication, raising the risk of overdoses or intensifying feelings of anxiety.
The recall was initiated in March, but the FDA last week designated it class II, meaning the pills may cause ‘temporary or medically reversible adverse health consequences.’
Recalled bottles were distributed nationwide between August 27, 2024, and May 29, 2025, according to the California State Board of Pharmacy. It’s unclear how many bottles were affected and the number of consumers who may have received them.
The lot number was 8177156, with bottles containing 60, 3mg extended-release pills. The FDA noted the expiration date was February 28, 2027.
The California State Board said the recall was issued ‘out of an abundance of caution,’ adding it is not aware of any reports of adverse reactions.
Consumers can call their local pharmacy to see if their Xanax prescription is part of the recall.
The popular anxiety drug Xanax has been recalled because it may not properly dissolve and release its ingredients (stock image)
Xanax is the brand name for alprazolam, which belongs to a class of drugs called benzodiazepines that act as sedatives to slow the nervous system down.
The drug is typically prescribed to treat anxiety and panic disorders and provide short-term relief from situational anxiety, such as giving a speech or flying on an airplane.
About 16 million prescriptions for the drug are filled every year in the US.
The Xanax pills in the recall were extended-release, meaning they release the active ingredients slowly into the body over a prolonged period rather than all at once.
This is meant to reduce the number of daily doses needed and lower the risk of side effects such as drowsiness, fatigue, dizziness, impaired coordination, memory issues, slurred speech or blurry vision.
However, drugs that have failed dissolution specifications do not break down at the correct rate, meaning it may be released too quickly or too slowly, reducing overall effectiveness.
This is a particular concern for Xanax because the drug can be highly addictive, as it enhances the effects of the neurotransmitter GABA and the feel-good hormone dopamine. Accidentally taking doses higher than intended may increase the risk of addiction.
And if the body is already dependent on Xanax or used to it, suddenly taking a smaller dose may trigger withdrawal symptoms such as heightened anxiety, panic attacks, seizures and insomnia.
Xanax is the latest drug to be pulled from shelves due to failed dissolution. Last month, the blood pressure medication Metoprolol Succinate Extended-Release Tablets were recalled for the same reason and given a Class II designation.
And last year, the statin atorvastatin calcium was pulled for the same reason, with the recall affecting 10mg, 20mg, 40mg and 80mg tablets.
