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CLASS II · ModerateFDA

SUN PHARMACEUTICAL INDUSTRIES INC recalls Fluocinonide

📅 Mar 25, 2026 · 📍 Nationwide
Recalling company
SUN PHARMACEUTICAL INDUSTRIES INC
Product
Fluocinonide, USP, 0.05% Cream, 30g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-2.
Reason
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Mar 25, 2026
Reported
Apr 22, 2026
Distribution
Nationwide in the USA.
Status
Ongoing
Quantity
41,712 30g tubes
Lot / codes
Lot# AD76251, Exp Date: 6/30/2026.
Company location
Princeton, NJ
Recall type
Voluntary: Firm initiated
Recall number
D-0476-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number D-0476-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.