Akorn recalls 0.05% Clobetasol Propionate Shampoo bottles due to CGMP deviations after firm went out of business. No remedy provided in official notice.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn is recalling 0.0:05% Clobetasol Propionate Shampoo bottles because the manufacturer went out of business and can no longer ensure product stability. This means the shampoo may not be safe for use.
The manufacturer went out of business and stopped stability testing. Without ongoing testing, the shampoo's effectiveness and safety cannot be guaranteed. This could lead to skin irritation or other issues if the product degrades.
People with prescriptions for this shampoo are affected. Those using it for skin conditions may be at risk if the product has degraded.
Check for Akorn brand shampoo bottles labeled 0.05% Clobetasol Propionate, 4oz (118 mL), with a prescription. All lots and all NDC numbers are affected.
Identify the product by checking the label for 0.05% Clobetasol Propionate, 4oz (118 mL), and prescription status.
The manufacturer went out of business and can no longer continue stability studies, which means the product's safety and effectiveness cannot be guaranteed.
The official notice does not provide a remedy.
Check for Akorn brand shampoo bottles labeled 0.05% Clobetasol Propionate, 4oz (118 mL), with a prescription. 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-0796-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0796-2023 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.
