· The FDA announced a voluntary recall of select lots of Xanax.
· The impacted lots may dissolve too quickly or not fast enough in the body.
· Patients who have concerns should contact their doctor.
The Food and Drug Administration has announced a voluntary recall of select lots of Xanax. The incredibly popular anti-anxiety medication was originally recalled by its distributor Viatris in mid-March, but was recalled nationwide on Wednesday for “failed dissolution specifications,” per the FDA.
This is classified as Class II, which is the FDA’s second most severe recall category. Products that fall into this classification “may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote,” per the FDA.
If you take Xanax, it’s understandable to be concerned. Here’s what the recall notice means, plus what to do next.
Meet the experts: Jamie Alan, Ph.D., an associate professor of pharmacology and toxicology at Michigan State University; Thea Gallagher, Psy.D., clinical associate professor of psychology at NYU Langone Health
What is Xanax?
Xanax is the brand name for alprazolam. The medication is used to treat anxiety disorders and panic disorder, according to the National Library of Medicine.
The drug is in a class of medications called benzodiazepines, and works by decreasing abnormal excitement in the brain.
Xanax can be taken on demand or daily, and typically kicks in within 30 minutes of taking a dose. The impacted form of Xanax, Xanax XR, is taken once a day and is designed to provide a slow release of medication throughout the day.
What does the recall notice say?
The recall specifically impacts 3-milligram tablets of Xanax XR, which is sold in 60-tablet bottles.
The recall impacts pills with the lot number 8177156 and an expiration date of 02/28/2027, per the FDA’s notice.
“This lot is being recalled out of an abundance of caution after testing some of the tablets produced out-of-specification dissolution results,” a spokesperson for Viatris told Prevention in a statement. “Patient safety and the quality of our medicines are of the utmost importance to Viatris.”
The lot was distributed in the U.S. between August 27, 2024, and May 29, 2025. “The risk to the patient associated with this event is considered to be negligible,” the spokesperson said. “To date, no reports of adverse reactions associated with this lot have been received.”
What are ‘failed dissolution specifications’?
It comes down to how the medication responds once it’s in your body. “Failed dissolution specifications mean the tablets won’t break down properly in the body, potentially leading to lower-than-expected drug absorption and reduced therapeutic effect,” says Thea Gallagher, PsyD, clinical associate professor of psychology at NYU Langone Health.
But this could also mean that the drug dissolves at a faster-than-expected rate, according to Jamie Alan, Ph.D., an associate professor of pharmacology and toxicology at Michigan State University. “These are extended-release pills, so it gets a bit more complex because these release drug over time, verses releasing the drug all at once,” she says.
There’s no publicly-released data on how close the tablets were to the dissolution specifications, and Alan says it may have been close or very different. “It could be undetectable in most patients, and it could cause issues—it’s hard to say,” she says.
Those who notice a change may experience a range of potential issues, according to Gallagher. “If the tablets don’t dissolve properly, patients may experience inadequate control of their anxiety or panic symptoms,” she says. “This is particularly problematic because alprazolam is a short-acting benzodiazepine with a half-life of about 11 hours, meaning patients rely on consistent dosing throughout the day to maintain symptom control.”
People who have a lower-than-usual dose may also deal with withdrawal or rebound symptoms, Gallagher says. Those can include anxiety, insomnia, restlessness, irritability, and, in severe cases, seizures, hallucinations, or delirium
“Since the dissolution failure may not be uniform across all tablets, patients could experience unpredictable fluctuations in their blood levels, making it difficult to distinguish between their underlying condition worsening versus medication-related issues,” Gallagher says.
No other batches of Xanax XR or its generic versions are impacted.
Is it safe to keep taking Xanax?
Based on the date that this Xanax lot was distributed, people likely would have already taken it, Alan says. However, she points out that there’s a chance that some medication in this lot is still in pharmacies, which is why the recall was issued. (The recall is directed at pharmacies, according to the Viatris spokesperson.)
However, if you’re taking Xanax XR and have concerns, Alan says it’s a good idea to reach out to your prescribing doctor and pharmacy to see if your medication could be impacted.
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