LUPIN SOMERSET recalls Fluocinolone Acetonide Topical Solution, USP, 0.01 %, 60 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals,
Lupin Somerset recalls fluocinolone acetonide topical solution 0.01% 60mL bottles due to impurities from oxidative degradation. This may cause serious injury. Stop using and contact for return.
Stop using this now
Failed Impurities/Degradation Specifications: Expansion of October 2018 recall due to elevated out of specification results for total impurities that have been chemically identified as oxidative degradation products of the fluocinolone active pharmaceutical ingredient.
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What happened, in plain English
Lupin Somerset is recalling fluocinolone acetonide topical solution 0.01% 60mL bottles because they contain impurities from oxidative degradation of the active ingredient. This could lead to serious injury if used as intended. Read more at govinfonow.com/recall/39245-lupin-somerset-fluocinolone-acetonide-topical-solution-recall-impurities-risk-serious.
Source Summary by GovInfoNow · govinfonow.com/recall/39245-lupin-somerset-fluocinolone-acetonide-topical-solution-recall-impurities-risk-serious · Updated October 5, 2026 · FDA enforcement record: FDA #D-0390-2019
Cite this page
“Lupin Somerset Fluocinolone Acetonide Topical Solution Recall: Impurities Risk Serious Injury.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39245-lupin-somerset-fluocinolone-acetonide-topical-solution-recall-impurities-risk-serious. Based on FDA recall #D-0390-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0390-2019%22&limit=1).
Why it’s dangerous
The product contains impurities that are chemical breakdown products of the active ingredient. These impurities can cause serious injury when applied to the skin.
Who’s affected
People with prescriptions for this topical solution from Lupin Somerset. Those using the product for skin conditions are most at risk.
How to tell if you have this one
Check for the 60mL bottle labeled 'Fluocinolone Acetonide Topical Solution, USP, 0.01%'. Look for lot numbers S700214 through S800791 with expiration dates up to July 2020.
- Brand
Lupin Somerset- Category
Drug
What to do — step by step
Stop Using Now
Immediately stop using the recalled product as it may cause serious injury.
Questions people ask
Why is this product being recalled?
The product contains impurities from oxidative degradation of the active ingredient, which can cause serious injury.
What should I do if I have this product?
Stop using it immediately and contact Lupin Somerset for a return or refund.
How can I tell if I have the recalled product?
Check for the 60mL bottle labeled 'Fluocinolone Acetonide Topical Solution, USP, 0.01%' with lot numbers S700214 through S800791.
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-0390-2019 — Lupin Somerset Lupin Somerset Hello, I own a Lupin Somerset that is covered by recall D-0390-2019 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-0390-2019 (January 15, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0390-2019 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.