Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Fluocinolone Acetonide Topical Solution Recalled by LUPIN SOMERSET Due to Failed Impurities/Degradation Specifications:Out of specification result noticed for...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact LUPIN SOMERSET directly.
Affected Products
Fluocinolone Acetonide Topical Solution, USP 0.01%, 60ml Bottle, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, MD 21202 Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873. NDC 43386-069-60
Quantity: 2712 60-ml bottles
Why Was This Recalled?
Failed Impurities/Degradation Specifications:Out of specification result noticed for total impurities observed during stability analysis
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About LUPIN SOMERSET
LUPIN SOMERSET has 13 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report