Fluocinolone Acetonide recalls

Fluocinolone Acetonide products have been recalled 9 times, most recently on 21 Jan 2026. The recalling company is usually Lyne Laboratories. The most common reason is potency & assay.

Total recalls9since 2014

Last 12 months1reported

Class I00% of total

Ongoing1latest 21 Jan 2026

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 1Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 6 67%Class III 3 33%

Why fluocinolone acetonide is recalled

Potency & Assay778%
Other Reasons222%

Companies

Product types

Creams, Ointments & Gels778%
Eye Drops111%

By year

2026111%
2024111%
2019111%
2018444%
2017111%
2014111%

Ongoing fluocinolone acetonide recalls

1 active

Reported	Class	Recall	Company	Reason	Where
21 Jan 2026Drug	CLASS III	Fluocinolone Acetonide Solution Topical Solution recalledFluocinolone Acetonide	Sun Pharmaceutical Industries	Potency & Assay	Nationwide

All fluocinolone acetonide recalls, newest first

9 total

Reported	Class	Recall	Company	Reason	Where
21 Jan 2026Drug	CLASS III	Fluocinolone Acetonide Solution Topical Solution recalledFluocinolone Acetonide	Sun Pharmaceutical Industries	Potency & Assay	Nationwide
31 Jan 2024Drug	CLASS II	Fluocinolone Acetonide Oil, 01% (Ear Drops), package in fill volume) recalledFluocinolone Acetonide	Glenmark Pharmaceuticals Inc., U	Potency & Assay	Nationwide
30 Jan 2019Drug	CLASS II	Fluocinolone Acetonide Topical Solution, USP, 01 % recalledFluocinolone Acetonide	Lupin Somerset	Potency & Assay	Nationwide
31 Oct 2018Drug	CLASS II	Fluocinolone Acetonide Topical Solution recalled by Lupin SomersetFluocinolone Acetonide	Lupin Somerset	Potency & Assay	Nationwide
2 May 2018Drug	CLASS II	Fluocinolone Acetonide Topical Oil, 01% (Body Oil) recalledFluocinolone Acetonide	Lyne Laboratories	Potency & Assay	MA
2 May 2018Drug	CLASS II	Fluocinolone Acetonide Topical Oil, 01% (Ear Drops) recalledFluocinolone Acetonide	Lyne Laboratories	Potency & Assay	MA
2 May 2018Drug	CLASS II	Fluocinolone Acetonide Topical Oil, 01% (Scalp Oil) recalledFluocinolone Acetonide	Lyne Laboratories	Potency & Assay	MA
19 Apr 2017Drug	CLASS III	Fluocinolone Acetonide Topical Solution USP 01% For Topical recalledFluocinolone Acetonide	Novel Laboratories	Other	Nationwide
8 Jan 2014Drug	CLASS III	G & W Fluocinolone Acetonide Cream USP 025%, a) 15 gm recalledFluocinolone Acetonide	G & W Laboratories	Other	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.