LUPIN SOMERSET recalls Fluocinolone Acetonide Topical Solution, USP 0.01%, 60ml Bottle, Manufactured for: Lupin Pharmaceutical, Inc.
Lupin Somerset recalls Fluocinolone Acetonide Topical Solution 0.01% 60ml bottles due to impurities detected during stability testing. Affected lots may pose safety risks.
Recall notice
Failed Impurities/Degradation Specifications:Out of specification result noticed for total impurities observed during stability analysis
Contact the company & request your remedy
What happened, in plain English
Lup: Lupin Somerset is recalling Fluocinolone Acetonide Topical Solution 0.01% 60ml bottles because impurities were found during stability testing. This could pose safety risks to users. Read more at govinfonow.com/recall/39534-lupin-somerset-fluocinolone-acetonide-topical-solution-recall-impurities-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/39534-lupin-somerset-fluocinolone-acetonide-topical-solution-recall-impurities-risk · Updated October 6, 2026 · FDA enforcement record: FDA #D-0092-2019
Cite this page
“Lupin Somerset Fluocinolone Acetonide Topical Solution Recall: Impurities Risk.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/39534-lupin-somerset-fluocinolone-acetonide-topical-solution-recall-impurities-risk. Based on FDA recall #D-0092-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0092-2019%22&limit=1).
Why it’s dangerous
The product failed stability testing, showing impurities that could affect safety. This means the solution might not be as safe as it should be for skin use.
Who’s affected
People using the recalled topical solution for skin conditions. Those with sensitive skin or using the product long-term may be at higher risk.
How to tell if you have this one
Check for the 60ml bottle labeled 'Fluocinolone Acetonide Topical Solution, USP 0.01%'. The lot number M16666 with expiration date 12/2018 is affected.
- Brand
Lupin Somerset- Category
Drug
What to do — step by step
Check Product Details
Look for the 60ml bottle with lot number M16666 and expiration date 12/2018.
Questions people ask
Is this product safe to use?
The recall indicates impurities were found during stability testing, so it may not be safe. Consult a healthcare provider for advice.
How can I tell if I have the recalled product?
Check for the 60ml bottle with lot number M16666 and expiration date 12/2018.
What should I do if I have the recalled product?
The recall does not specify a remedy, so contact Lupin Somerset for guidance.
Contact Lupin Somerset
We’ve drafted a message you can send Lupin Somerset to request your refund or repair — edit it as you like.
Subject: Recall D-0092-2019 — Lupin Somerset Lupin Somerset Hello, I own a Lupin Somerset that is covered by recall D-0092-2019 from Lupin Somerset. 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-0092-2019 (October 5, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0092-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 6, 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.