Akorn Inc recalls Clobetasol Propionate Emollient Cream 0.05%, a) 30 gram (NDC 50383-270-30) and b) 60 gram (NDC 50383-270-60) tubes, Rx
Akorn recalls 0.05% Clobetasol Propionate Emollient Cream tubes due to stability failure. Out of specification preservative results at 9-month study. Rx only.
Lower-risk recall
Failed Stability Specification; out of specification (OOS) results for a preservative at 9 month stability study.
Contact the company & request your remedy
What happened, in plain English
Akorn is recalling 0.05% Clobetasol Propionate Emollient Cream tubes that failed stability testing. This means the preservative may not work properly over time, potentially causing the product to become unsafe. People with prescriptions for this medication should check their tubes. Read more at govinfonow.com/recall/39229-akorn-clobetasol-cream-0-05-recall-stability-issue.
Source Summary by GovInfoNow · govinfonow.com/recall/39229-akorn-clobetasol-cream-0-05-recall-stability-issue · Updated October 5, 2026 · FDA enforcement record: FDA #D-0515-2019
Cite this page
“Akorn Clobetasol Cream 0.05% Recall: Stability Issue.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39229-akorn-clobetasol-cream-0-05-recall-stability-issue. Based on FDA recall #D-0515-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0515-2019%22&limit=1).
Why it’s dangerous
The product failed a 9-month stability test, showing the preservative was out of specification. This could mean the cream might not stay safe or effective over time, but it doesn't indicate immediate harm.
Who’s affected
Prescription holders of the 30g and 60g Clobetasol cream tubes. Those with the specific NDC numbers and expiration dates listed are most at risk.
How to tell if you have this one
Check for 30g or 60g tubes labeled 'Clobetasol Propionate Emollient Cream 0.05%'. Look for NDC numbers 50383-270-30 or 50383-270-60 with specific expiration dates.
- Brand
Akorn- Category
Drug
What to do — step by step
Check Product Details
Look for the NDC numbers 50383-270-30 or 50383-270-60 on the tube.
Questions people ask
Is this product safe to use?
The product failed stability testing but does not indicate immediate harm. It may become unsafe over time.
What should I do with the recalled product?
The recall record does not specify a remedy, so no action is required beyond checking if you have the product.
How can I tell if I have the recalled product?
Check for the NDC numbers 50383-270-30 or 50383-270-60 with specific expiration dates listed.
Contact Akorn
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0515-2019 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0515-2019 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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Where this comes from
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.
- Official source: FDA Recall #D-0515-2019 (January 25, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0515-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.