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Viatris recalls Xanax over dissolution failure risks

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Viatris recalls Xanax over dissolution failure risks
Key Points
  • Viatris voluntarily recalled a specific lot of Xanax due to dissolution failures that could cause overdose or anxiety risks.
  • The FDA designated it a class II recall, with bottles distributed nationwide between August 2024 and May 2025.
  • Consumers should check with pharmacies, as no adverse reactions have been reported yet, but the recall's full impact is unknown.

The Pennsylvania-based company initiated the recall in March, but the FDA recently classified it as class II, indicating the pills may cause temporary or medically reversible adverse health consequences. The recall affects 60-tablet bottles of 3mg extended-release Xanax with lot number 8177156 and an expiration date of February 28, 2027. According to the California State Board of Pharmacy, these bottles were distributed nationwide between August 27, 2024, and May 29, 2025.

The recall was prompted by 'failed dissolution specifications,' meaning the pills may not dissolve correctly and release their active ingredient at the expected rate. This could lead to patients receiving too much or too little medication, increasing risks of overdoses or intensified anxiety. Xanax, the brand name for alprazolam, is a benzodiazepine that acts as a sedative to slow the nervous system.

out of an abundance of caution

California State Board, Pharmacy regulatory body

S. The recalled pills are extended-release, designed to release active ingredients slowly over time rather than all at once. The California State Board said the recall was issued 'out of an abundance of caution,' adding it is not aware of any adverse reaction reports.

Consumers are advised to contact their local pharmacy to check if their prescription is part of the recall. The full scope of the recall's impact, including how many bottles were affected and how many consumers may have received them, remains unclear. Xanax is the latest drug to be pulled from shelves due to dissolution failures, though specific test failures have not been disclosed.

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