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FDA issues Class II recall for anti-anxiety medication Oscar Ochoa | Unsplash

A certain batch of anti-anxiety drug Xanax is being recalled following reports that federal regulators discovered a manufacturing issue tied to its proper dissolution in the body once ingested. This means that the drug did not dissolve at the standard rate and could cause health-related issues.

Widely prescribed for people dealing with anxiety disorders or panic attacks, the recall only covers one lot of Xanax XR (alprazolam) extended-release 3-milligram tablets packaged in 60-count bottles according to the FDA.

Further, the recall refers to tablets that were released in the US between 27 August 2024 and 29 May 2025. Viatris Specialty was mentioned as the company behind the affected drug. The bottle, said to be under lot No. 8177156 carried an expiration date of 28 February 2027 according to the California State Board of Pharmacy.

FDA Class II Recall Raises Safety Concerns

As a standard, pharmacies are generally required to remove the medication from their shelves under Class II recalls. Under this kind of recall, the FDA warns that drugs covered by it could result in temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

So for people who may be taking medications that fall under a Class II recall, it would be best to stop taking them and seek the advice of their physician or doctor, KTLA.com reported.

Hence, those who may be using Xanax XR would do well to immediately consult their doctor on this recall. With the potential hazards of the drug, only licensed physicians are at liberty to suggest alternatives for the anti-anxiety drug.

This recall follows a previous initiative by Viatris on 17 March. At the time, the company recalled some of the pills because they did not meet dissolution specifications. This then indicates that the pill may not be as effective or may not release the correct dosage per a report by WCVB.

On its own, alprazolam has been known to potentially cause some side effects when ingested. Among the more common ones enumerated by Drugs.com include:

  • Forgetfulness
  • Changes in speech patterns or rhythm
  • Clumsiness or unsteadiness
  • Poor coordination
  • Feelings of discouragement
  • Drowsiness
  • Feeling sad or empty
  • Irritability
  • Reduced appetite
  • Lightheadedness
  • Loss of interest or pleasure
  • Feeling relaxed or unusually calm
  • Shakiness or an unsteady walk
  • Excessive sleepiness or unusual drowsiness
  • Slurred speech
  • Fatigue
  • Difficulty concentrating
  • Difficulty speaking
  • Difficulty carrying out routine tasks
  • Trouble sleeping
  • Unsteadiness, trembling, or other issues with muscle control or coordination
  • Unusual tiredness or weakness

Aside from these, there are also less common side effects such as stomach pain, blurred vision, body aches, chills or loss of voice among others. Some of the rare side effects it could render include chest pain, out of control actions, ear pain and feeling jittery.

It should be noted that not all of these side effects may occur. This is the reason why it is important for people prescribed to take alprazolam to check with their physician to avoid complications.

The recall for the affected batch raises risks, which is even more reason for anyone taking the medication to immediately stop taking it. There are alternatives, and only doctors can properly recommend the right treatment for affected patients.