The Recall Desk
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.

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: 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
  • cgmp-deviation
  • incomplete-stability-data

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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