The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0794-2023·Announced 2023-06-07

Clobetasol Propionate Cream Recalled Due to CGMP Violations and Unverified Stability

Akorn, Inc. is recalling all lots of Clobetasol Propionate Cream 0.05% nationwide because the manufacturer went out of business before completing required stability studies to verify product safety and efficacy.

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 2/5 (Moderate).

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: This is an FDA Class II recall initiated due to manufacturing quality deviations and the manufacturer's inability to complete required stability verification. No illnesses or injuries have been reported. The recall is precautionary in nature.

Plain-English summary

Clobetasol Propionate Cream, USP, 0.05% is being recalled by Akorn, Inc. The product is supplied in 15g, 30g, and 60g tubes and distributed nationwide in the United States and Puerto Rico under all lot numbers.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Akorn, Inc. went out of business and is unable to continue stability studies required by the FDA to verify that the product maintains its intended safety and efficacy throughout its shelf life. Stability studies are necessary to demonstrate that a drug product does not degrade in a manner that could compromise safety or effectiveness.

The recalled product

Product
Clobetasol Propionate Cream, USP, 0.05%, packaged in a) 15g tubes, b) 30g tubes, and c) 60g tubes, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
Manufacturer
Akorn, Inc.
Category
Drug
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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