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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 Impurities Specs

Agency Publication Date: January 23, 2019
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Summary

LUPIN SOMERSET has expanded a previous recall to include approximately 24,180 additional bottles of Fluocinolone Acetonide Topical Solution, USP, 0.01% (60 mL). This prescription medication is being recalled because testing found elevated levels of impurities that were chemically identified as oxidative degradation products of the active ingredient. The product was distributed nationwide across the United States and Puerto Rico.

Risk

The presence of these degradation products means the medication may not meet quality standards for purity and effectiveness, potentially altering the expected therapeutic results for patients treating skin conditions.

What You Should Do

  1. Locate your 60 mL bottle of Fluocinolone Acetonide Topical Solution, USP, 0.01% and check the label for NDC 43386-069-60.
  2. Identify if your product is part of the recall by checking for the following lot numbers and 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), and S800791 (Exp Jul-20).
  3. Contact your healthcare provider or pharmacist immediately to discuss using an alternative medication and to receive guidance on your treatment plan.
  4. Return any unused bottles from the affected lots to your pharmacy to request a refund.
  5. Contact the manufacturer, Lupin Pharmaceuticals, Inc., for further instructions regarding the return process or if you have questions about the product quality.
  6. For additional questions or to report a problem, 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 healthcare provider and return product for refund.

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

Affected Products

Product: Fluocinolone Acetonide Topical Solution, USP, 0.01 % (60 mL bottle)
Model:
NDC 43386-069-60
Recall #: D-0390-2019
Lot Numbers:
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)
Date Ranges: Apr-19, Jun-19, Oct-19, Nov-19, Feb-20, Mar-20, May-20, Jul-20

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81925
Status: Resolved
Manufacturer: LUPIN SOMERSET
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 24,180 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.