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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Topical Products

LUPIN SOMERSET: Fluocinolone Acetonide Topical Solution Recalled for Failed Impurity Standards

Agency Publication Date: October 24, 2018
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Summary

Lupin Somerset is voluntarily recalling 2,712 bottles of Fluocinolone Acetonide Topical Solution, USP 0.01% (60ml), a prescription medication used to treat skin conditions. This recall was initiated after stability testing revealed that the product did not meet official specifications for total impurities and degradation over time. Consumers who have this medication should contact their healthcare provider or pharmacist for guidance and return any unused product to the pharmacy for a refund.

Risk

The presence of impurities or degradation products beyond specified limits means the medication may not be as effective as intended or could potentially cause unexpected side effects, though no specific adverse events have been reported for this lot.

What You Should Do

  1. Check your medication bottle for the product name 'Fluocinolone Acetonide Topical Solution, USP 0.01%' in a 60ml bottle size.
  2. Verify if your bottle belongs to the affected lot by looking for Lot Number M16666 with an expiration date of 12/2018 printed on the label.
  3. Confirm the National Drug Code (NDC) 43386-069-60 is present on the packaging.
  4. Contact your healthcare provider or pharmacist immediately to discuss alternative treatments if you are currently using this medication.
  5. Return any unused portion of the recalled medication to the place of purchase or pharmacy for a refund.
  6. Contact the manufacturer, Lupin Somerset, for further instructions regarding this recall.
  7. For additional information, you can contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

How to: Return the affected product to the place of purchase for a refund and consult a medical professional for alternative treatment.

Affected Products

Product: Fluocinolone Acetonide Topical Solution, USP 0.01% (60ml Bottle)
Model:
NDC 43386-069-60
Recall #: D-0092-2019
Lot Numbers:
M16666 (Exp 12/2018)
Date Ranges: Expiration Date 12/2018

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81168
Status: Resolved
Manufacturer: LUPIN SOMERSET
Sold By: pharmacies nationwide
Manufactured In: United States
Units Affected: 2712 60-ml bottles
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.