Fluocinolone Acetonide recalls

The FDA has published 13 recalls involving Fluocinolone Acetonide since 2014. The latest was reported on 21 Jan 2026. Most were for potency & assay. Hill Dermaceuticals has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls13since 2014
Last 12 months1reported
Class I00% of total
Ongoing1latest 21 Jan 2026

Recalls per month, last 24 months

click a bar for that month

Severity split

Class I 0 0%Class II 7 54%Class III 6 46%

Why fluocinolone acetonide is recalled

By year

Ongoing fluocinolone acetonide recalls

1 active
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIIFluocinolone Acetonide Solution Topical Solution recalledFluocinolone AcetonideSun Pharmaceutical IndustriesPotency & AssayNationwide

All fluocinolone acetonide recalls, newest first

13 total
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIIFluocinolone Acetonide Solution Topical Solution recalledFluocinolone AcetonideSun Pharmaceutical IndustriesPotency & AssayNationwide
DrugCLASS IIFluocinolone Acetonide Oil, 01% (Ear Drops), package in fill volume) recalledFluocinolone AcetonideGlenmark Pharmaceuticals Inc., UPotency & AssayNationwide
DrugCLASS IIDermOtic Oil (fluocinolone acetonide oil) 01% Ear Drops recalledDermoticHill DermaceuticalsForeign MaterialNationwide
DrugCLASS IIFluocinolone Acetonide Topical Solution, USP, 01 % recalledFluocinolone AcetonideLupin SomersetPotency & AssayNationwide
DrugCLASS IIFluocinolone Acetonide Topical Solution recalled by Lupin SomersetFluocinolone AcetonideLupin SomersetPotency & AssayNationwide
DrugCLASS IIFluocinolone Acetonide Topical Oil, 01% (Body Oil) recalledFluocinolone AcetonideLyne LaboratoriesPotency & AssayMA
DrugCLASS IIFluocinolone Acetonide Topical Oil, 01% (Ear Drops) recalledFluocinolone AcetonideLyne LaboratoriesPotency & AssayMA
DrugCLASS IIFluocinolone Acetonide Topical Oil, 01% (Scalp Oil) recalledFluocinolone AcetonideLyne LaboratoriesPotency & AssayMA
DrugCLASS IIIFluocinolone Acetonide Topical Solution USP 01% For Topical recalledFluocinolone AcetonideNovel LaboratoriesOtherNationwide
DrugCLASS IIIRoyal Pharmaceuticals Derma-Smoothe/FS fluocinolone recalledDerma-smoothe/fsHill DermaceuticalsPotency & AssayNationwide

Should you stop taking Fluocinolone Acetonide?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.