The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0796-2023·Announced 2023-06-07

Clobetasol Propionate Shampoo Recall Due to Manufacturing Compliance Issues

Akorn, Inc. is recalling all lots of Clobetasol Propionate Shampoo, 0.05% distributed nationwide after the firm closed and could not continue required stability studies.

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 without reported illnesses, injuries, or deaths. The hazard is procedural—incomplete stability data due to manufacturer closure—rather than an active contamination or defect. When no illnesses or injuries are reported and the hazard is theoretical, the score is at most 3; the procedural nature places it in the Moderate category.

Plain-English summary

Akorn, Inc. is recalling all lots of Clobetasol Propionate Shampoo, 0.05%, a prescription-only topical medication. The product was distributed nationwide in the USA and Puerto Rico under all NDCs.

The recall was issued because the manufacturer ceased operations and could not complete stability studies required by Current Good Manufacturing Practice (CGMP) regulations. Stability studies ensure that a drug maintains its safety and effectiveness throughout its shelf life.

The recalled product

Product
Clobetasol Propionate Shampoo, 0.05%, 4oz (118 mL) bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
Manufacturer
Akorn, Inc.
Category
Drug — Dermatological
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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