Use caution Drug recall · FDA · Published January 15, 2019

Lupin Recalls Fluocinolone Acetonide Topical Solution Due to Impurities

Lupin Pharmaceuticals recalls 24,180 bottles of Fluocinolone Acetonide Topical Solution due to elevated impurities from oxidative degradation.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0390-2019Drug Lupin Somerset ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmLUPIN SOMERSET400 Campus Dr · Somerset, NJ 08873-1145

✎ GovInfoNow plain-language explainer

Lupin Somerset is recalling Fluocinolone Acetonide Topical Solution because the product contains elevated levels of total impurities. These impurities have been chemically identified as oxidative degradation products of the active ingredient. The recall affects specific lots distributed nationwide in the USA and Puerto Rico. Read more at govinfonow.com/recall/39245-lupin-recalls-fluocinolone-acetonide-topical-solution-due-to-impurities.

Source Summary by GovInfoNow · govinfonow.com/recall/39245-lupin-recalls-fluocinolone-acetonide-topical-solution-due-to-impurities · Updated October 11, 2026 · FDA enforcement record: FDA #D-0390-2019

Cite this page

“Lupin Recalls Fluocinolone Acetonide Topical Solution Due to Impurities.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/39245-lupin-recalls-fluocinolone-acetonide-topical-solution-due-to-impurities. Based on FDA recall #D-0390-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0390-2019%22&limit=1).

Lupin Somerset is recalling Fluocinolone Acetonide Topical Solution, USP, 0.01%, due to elevated out-of-specification results for total impurities identified as oxidative degradation products. The FDA announced the recall on Jan. 15, 2019.

How to tell if you have it

Brand: Lupin Somerset
Product: Fluocinolone Acetonide Topical Solution, USP, 0.01%, 60 mL bottle
NDC: 43386-069-60
Lot codes: S700214 (Exp Apr-19), S700447 (Exp Jun-19), S700787 (Exp Oct-19), S701057 (Exp Nov-19), S800107 (Exp Feb-20), S800266 (Exp Mar-20), S800524 (Exp May-20), S800791 (Exp Jul-20)
Distribution: Nationwide in the USA and Puerto Rico

The hazard

The recall is due to failed impurities and degradation specifications, specifically elevated out-of-specification results for total impurities that have been chemically identified as oxidative degradation products of the fluocinolone active pharmaceutical ingredient.

Context

GovInfoNow's records show Lupin Somerset has 8 other recalls on record since May 24, 2018. Other recent recalls include a March 19, 2019 labeling error for Gavilyte-N packets and a Dec. 21, 2018 subpotent drug risk for Nitrofurantoin Oral Suspension. Similar products have faced recalls, including a Dec. 30, 2025 impurity risk for Sun Pharmaceutical Fluocinolone Acetonide Solution and an Nov. 13, 2025 impurity risk for Lupin Ganirelix Acetate Injection.

How to tell if you have this one

Check your bottle for the label 'Fluocinolone Acetonide Topical Solution, USP, 0.01 %, 60 mL bottle'. Look for NDC 43386-069-60 and one of the following lot numbers with their corresponding expiration dates: S700214 (Exp Apr-19), S700447 (Exp Jun-19), S700787 (Exp Oct-19), S701057 (Exp Nov-19), S800107 (Exp Feb-20), S800266 (Exp Mar-20), S800524 (Exp May-20), or S800791 (Exp Jul-20).

Brand
Lupin Somerset
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Your Bottle
Verify if your bottle matches the recalled NDC and lot numbers listed in the record.
Contact Your Pharmacist
Speak with your pharmacist or healthcare provider to determine if you have a recalled lot and discuss next steps for replacement or disposal.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide in the USA and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 4.1 years after the firm started it.

Jan 15, 2019Firm started the recall
Jan 23, 2019FDA classified it Class II
Jan 30, 2019Published in FDA’s Enforcement Report
Feb 17, 2023FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/39245-lupin-recalls-fluocinolone-acetonide-topical-solution-due-to-impurities">Lupin Recalls Fluocinolone Acetonide Topical Solution Due to Impurities (GovInfoNow)</a>

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 qwen3.6:35b-a3b on October 11, 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.