Akorn recalls all 0.05% clobetasol propionate ointment tubes due to stability concerns after the company went out of business and could no longer conduct required testing.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn has recalled all 15g tubes of prescription clobetasol prop: the company went out of business and can no longer ensure the ointment remains stable. This means the product may not be safe for use as it could degrade over time.
The company went out of business and could no longer perform stability studies. This means the ointment's quality and safety over time cannot be guaranteed, potentially leading to degradation.
Prescription users of clobetasol propionate ointment 0.05% 15g tubes. Those who have the product and are using it for medical purposes are most at risk.
Check for Akorn brand 0.05% clobetasol propionate ointment 15g tubes. All lots and all NDC numbers are affected.
Identify the product by checking the label for Akorn, 0.05% clobetasol propionate ointment, 15g tubes.
The company went out of business and could no longer continue stability studies, so the product's safety and quality cannot be guaranteed.
The recall record does not specify a remedy.
Check for Akorn brand 0.05% clobetasol propionate ointment 15g tubes; all lots and all NDC numbers 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-0795-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0795-2023 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
