Fluocinolone Acetonide: 7 recalls on record

Recalled by 1 agency: FDA (7).

First recall on record: January 8, 2014. Most recent: January 21, 2026.

Risk classification: Class II: 4 · Class III: 3

Most recent recalls

DateAgencyProduct
January 21, 2026FDAFluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx only, Dist…D-0256-2026
January 31, 2024FDAFluocinolone Acetonide Oil, 0.01% (Ear Drops), package in 1 Oz. (20 mL fill volume) bottl…D-0259-2024
October 31, 2018FDAFluocinolone Acetonide Topical Solution, USP 0.01%, 60ml Bottle, Manufactured for: Lupin …D-0092-2019
May 2, 2018FDAFluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil) 118.28 mL (4 fl.oz.) Rx Only, Manuf…D-0713-2018
May 2, 2018FDAFluocinolone Acetonide Topical Oil, 0.01% (Ear Drops) 20 mL, Rx Only, Manufactured by: Ly…D-0712-2018
April 19, 2017FDAFluocinolone Acetonide Topical Solution USP 0.01% For Topical Use Only, Not for Ophthalmi…D-0653-2017
January 8, 2014FDAG & W Fluocinolone Acetonide Cream USP 0.025%, a) 15 gm (NDC 0713-0222-15), b) 60 gm (NDC…D-391-2014

Questions about this brand

How many recalls does Fluocinolone Acetonide have?
Recalert has 7 U.S. recalls on record for Fluocinolone Acetonide, published between January 8, 2014 and January 21, 2026.
What was the most recent Fluocinolone Acetonide recall?
FDA recall D-0256-2026, published January 21, 2026: Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx only, Dist. by: Taro Pharmaceuticals Inc., Hawthorn, NY 10532. NDC 51672-1365-4
Which agencies have recalled Fluocinolone Acetonide products?
Fluocinolone Acetonide products appear in recalls from: FDA (7).

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