FDA Drug Recalls

Recalls / Generics / Fluocinolone Acetonide

Fluocinolone Acetonide

13 FDA drug recalls involving generic “Fluocinolone Acetonide”.

DateClassProductFirm
2025-12-30Class IIIFluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx only, Dist. by: Taro PharmaceutSUN PHARMACEUTICAL INDUSTRIES INC
2024-01-04Class IIFluocinolone Acetonide Oil, 0.01% (Ear Drops), package in 1 Oz. (20 mL fill volume) bottle, Rx only, ManufactuGlenmark Pharmaceuticals Inc., USA
2021-05-21Class IIDermOtic Oil (fluocinolone acetonide oil) 0.01% Ear Drops 20 mL bottles, Rx only, Manufactured by: Hill DermHill Dermaceuticals, Inc.
2019-01-15Class IIFluocinolone Acetonide Topical Solution, USP, 0.01 %, 60 mL bottle, Rx Only, Manufactured for: Lupin PharmaceuLUPIN SOMERSET
2018-10-05Class IIFluocinolone Acetonide Topical Solution, USP 0.01%, 60ml Bottle, Manufactured for: Lupin Pharmaceutical, Inc. LUPIN SOMERSET
2018-04-13Class IIFluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil) 118.28 mL (4 fl.oz.) Rx Only, Manufactured by: Lyne LaboLyne Laboratories, Inc.
2018-04-13Class IIFluocinolone Acetonide Topical Oil, 0.01% (Ear Drops) 20 mL, Rx Only, Manufactured by: Lyne Laboratories, Inc.Lyne Laboratories, Inc.
2018-04-13Class IIFluocinolone Acetonide Topical Oil, 0.01% (Body Oil) 118.28 mL (4 fl. oz.) Rx Only, Manufactured by: Lyne LaboLyne Laboratories, Inc.
2017-02-22Class IIIFluocinolone Acetonide Topical Solution USP 0.01% For Topical Use Only, Not for Ophthalmic Use, 60 mL bottle,Novel Laboratories, Inc.
2014-01-31Class IIIROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% (Scalp Oil), 4 fl.oz., Rx only ManufacturHill Dermaceuticals, Inc.
2014-01-31Class IIIROYAL PHARMACEUTICALS DermOtic Oil fluocinolone acetonide 0.01% (Ear Drops), 20 ml, Rx only Manufactured by:Hill Dermaceuticals, Inc.
2014-01-31Class IIIROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Body Oil) 4 fl. oz., Rx only Hill Dermaceuticals, Inc.
2013-09-30Class IIIG & W Fluocinolone Acetonide Cream USP 0.025%, a) 15 gm (NDC 0713-0222-15), b) 60 gm (NDC 0713-0222-60 ), Rx OG & W Laboratories Inc