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Class II · ModerateActive recall

Fluocinonide

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot# AD76252, Exp Date: 6/30/2026.
Where it was soldNationwide in the USA.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made bySun Pharmaceutical Industries, Inc.
Brand nameFLUOCINONIDE
Generic nameFLUOCINONIDE
Active ingredient(s)FLUOCINONIDE
Distributed by / forSUN PHARMACEUTICAL INDUSTRIES INC
NDC51672-1386-1
Show the full FDA record
Full product labelFluocinonide, USP, 0.05% Cream, 15g 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 51672-1386-1
Recalling firmSUN PHARMACEUTICAL INDUSTRIES INC
DistributionNationwide in the USA.
Quantity24,672 15 g tubes
Recall initiated2026-03-25
Report date2026-04-22
Recall completed—
Recall numberD-0475-2026
ClassificationClass II
FDA statusOngoing
Origin on filePrinceton NJ United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.