The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0844-2022·Announced 2022-05-11

Alprazolam XR Extended-Release Tablets Recalled Due to Dissolution Failure

Viatris Inc. is recalling alprazolam XR 3mg tablets (lot EH8348) distributed nationwide due to failed dissolution testing. Tablets may not dissolve properly, potentially reducing drug effectiveness.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall with no illnesses or injuries reported. The hazard—failed tablet dissolution—represents a theoretical risk of harm (reduced drug effectiveness) rather than documented injury. Per the rubric, recalls with no reported harm and theoretical hazards score at most High (3).

Plain-English summary

Viatris Inc. is recalling alprazolam XR 3mg extended-release tablets (60-count bottles) due to failed dissolution testing. The affected lot is EH8348 with an expiration date of August 2023 and was distributed nationwide.

Testing revealed low out-of-specification dissolution test results, meaning tablets from this lot may not dissolve properly in the body. This could reduce the drug's effectiveness in treating anxiety and panic disorders.

Patients taking tablets from lot EH8348 should discontinue use and contact their healthcare provider for a replacement prescription. Pharmacies and healthcare facilities should not dispense this product.

The recalled product

Product
ALPRAZOLAM (ALPRAZOLAM)
Brand
ALPRAZOLAM
Manufacturer
Viatris Inc
Category
Drug — Prescription Benzodiazepine
Hazard
Affected units
6,789

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot # EH8348
  • exp. date August 2023

Distribution

Distributed nationwide across the United States.

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