The Recall Desk
HighFDA (Drugs)·D-0795-2023·Announced 2023-06-07

Clobetasol Propionate Ointment recalled due to manufacturing compliance failures

Akorn, Inc. is recalling all lots of Clobetasol Propionate Ointment 0.05% due to manufacturing practice violations and inability to complete required stability studies. Product was distributed nationwide in the USA and Puerto Rico.

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: Class II FDA recall triggered by manufacturing practice deviations and inability to complete required stability testing. Product is a potent topical corticosteroid; unverified stability represents a risk-of-harm condition. No reported illnesses or injuries.

Plain-English summary

Akorn, Inc. is recalling Clobetasol Propionate Ointment, USP, 0.05%, distributed in 15 gram tubes, affecting all lots and all NDC codes. The product is a prescription-only topical corticosteroid.

The recall results from Current Good Manufacturing Practice (CGMP) deviations in the manufacturer's operations. Akorn, Inc. ceased business operations and was unable to continue the stability studies required to verify that the product maintains its labeled potency, purity, and safety characteristics throughout its shelf life.

The affected product was distributed nationwide in the United States and Puerto Rico.

The recalled product

Product
Clobetasol Propionate Ointment, USP, 0.05%, 15 g tubes, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
Manufacturer
Akorn, Inc.
Category
Drug — Topical Corticosteroid
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 →

Related recalls

Same manufacturer · Akorn, Inc.

See all →

Same hazard · cgmp violation

See all →