Akorn recalls 0.05% clobetasol propionate cream tubes due to stability concerns after manufacturer went out of business. All sizes and lots affected. No remedy specified.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn is recalling all sizes of 0.05% clobetasol propionate cream tubes because the company went out of business and can no longer ensure the product's stability. This means the cream may not be safe to use as intended.
The manufacturer went out of business and stopped stability testing, which means the product's effectiveness and safety could be compromised over time. Without ongoing testing, the cream might degrade or become unsafe for use.
Prescription users of the 15g, 30g, or 60g clobetasol cream tubes are affected. Those who have the product and are using it for medical purposes are at risk.
Check for Akorn-branded clobetasol propionate cream tubes labeled 15g, 30g, or 60g. All lots and all National Drug Codes (NDCs) are affected.
Identify the tube size (15g, 30g, or 60g) and confirm it's an Akorn brand product.
The recall states the manufacturer went out of business and can no longer ensure stability, so the product may not be safe. No specific remedy is provided.
The recall does not specify a remedy, so there is no instruction to stop using the product immediately.
Check for Akorn-branded clobetasol propionate cream tubes in 15g, 30g, or 60g sizes. All lots and NDCs are affected.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0794-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0794-2023 from Akorn. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
