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Class III · Lower riskActive recall

Fluocinolone Acetonide

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot #: AD81290, AD81291, AD81292 and AD81293, Exp. Date 1/31/2027
Where it was soldNationwide within 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 Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.

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 nameFLUOCINOLONE ACETONIDE
Generic nameFLUOCINOLONE ACETONIDE
Active ingredient(s)FLUOCINOLONE ACETONIDE
Distributed by / forSUN PHARMACEUTICAL INDUSTRIES INC
NDC51672-1365-4
Show the full FDA record
Full product labelFluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx only, Dist. by: Taro Pharmaceuticals Inc., Hawthorn, NY 10532. NDC 51672-1365-4
Recalling firmSUN PHARMACEUTICAL INDUSTRIES INC
DistributionNationwide within the USA
Quantity24,624 bottles
Recall initiated2025-12-30
Report date2026-01-21
Recall completed—
Recall numberD-0256-2026
ClassificationClass III
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.