The Recall Desk
HighFDA (Drugs)·D-0792-2023·Announced 2023-06-07

Ciclopirox Topical Solution Recalled Due to Manufacturing Practice Violations

Ciclopirox 8% topical solution (nail lacquer) is recalled nationwide. The manufacturer went out of business and could not complete required stability testing to ensure product safety.

What this means for you

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 involving CGMP deviations (incomplete stability studies). No illnesses or injuries are reported. The inability to complete stability testing represents a risk-of-harm situation where product safety cannot be verified, meeting the criterion for High severity.

Plain-English summary

Akorn, Inc. is recalling all lots of Ciclopirox Topical Solution 8% (Nail Lacquer), 6.6 mL bottles, distributed nationwide in the United States and Puerto Rico.

The FDA classified this as a Class II recall due to Current Good Manufacturing Practice (CGMP) deviations. The recalling firm went out of business and could no longer continue the stability studies required for this medication.

Consumers currently using this product should contact their healthcare provider for guidance.

The recalled product

Product
Ciclopirox Topical Solution 8% (Nail Lacquer), 6.6 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
Manufacturer
Akorn, Inc.
Category
Drug — Topical Antifungal
Hazard
  • cgmp-deviation
  • stability-testing-incomplete

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 (1)

  • All Lots

Distribution

Distributed nationwide across the United States.

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