The Recall Desk
ModerateFDA (Drugs)·D-0477-2023·Announced 2023-04-05

Finasteride Tablets Recalled Nationwide for Manufacturing Practice Deviations

Direct Rx is recalling 19 bottles of Finasteride 5 mg Tablets nationwide due to cGMP deviations. The firm initiated this recall voluntarily.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The FDA classified this as a Class II recall initiated voluntarily for manufacturing practice deviations. Per the severity rubric, voluntary precautionary recalls without identified specific hazards warrant a Moderate severity rating.

Plain-English summary

Direct Rx is recalling 19 bottles of Finasteride, USP, 5 mg Tablets distributed nationwide. The recalled bottles are 90-count packages (NDC 61919-0733-90) from lot numbers 19AU2205 and 12OC2211, both expiring 12/31/24.

The recall was initiated voluntarily by Direct Rx on March 13, 2023, due to cGMP deviations discovered during manufacturing. The FDA classified this as a Class II recall. The recall was terminated on June 17, 2024.

The recalled product

Product
Finasteride, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0733-90; Packaged and Distributed By: Direct Rx
Manufacturer
Direct Rx
Category
Drug — Finasteride
Hazard
  • manufacturing-deviation

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 (4)

  • Lot
  • expiry: 19AU2205
  • exp 12/31/24
  • 12OC2211

Distribution

Distributed nationwide across the United States.

Related recalls

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