The Recall Desk
Agency classClass IIOur severity: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.

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 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

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.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 86 recalled by Akorn, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 86 products in this recall →

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