Fluocinolone Acetonide recalls

Fluocinolone Acetonide products have been recalled 8 times, most recently on 21 Jan 2026. The recalling company is usually Lyne Laboratories. The most common reason is potency & assay.

Total recalls8since 2014

Last 12 months1reported

Class I00% of total

Ongoing1latest 21 Jan 2026

Recalls per month, last 24 months

click a bar for that month

0Dec '24 0 0 0Mar 0 0 0Jun 0 0 0Sep 0 0 0Dec 1 0 0Mar 0 0 0Jun 0 0 0Sep 0 0

Severity split

Class I 0 0%Class II 5 63%Class III 3 38%

Why fluocinolone acetonide is recalled

Potency & Assay675%
Other Reasons225%

Companies

Product types

Creams, Ointments & Gels788%
Eye Drops113%

By year

2026113%
2019113%
2018450%
2017113%
2014113%

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

8 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
30 Jan 2019Drug	CLASS II	Fluocinolone Acetonide Topical Solution, USP, 0.01 % 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, 0.01% (Body Oil) recalledFluocinolone Acetonide	Lyne Laboratories	Potency & Assay	MA
2 May 2018Drug	CLASS II	Fluocinolone Acetonide Topical Oil, 0.01% (Ear Drops) recalledFluocinolone Acetonide	Lyne Laboratories	Potency & Assay	MA
2 May 2018Drug	CLASS II	Fluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil) recalledFluocinolone Acetonide	Lyne Laboratories	Potency & Assay	MA
19 Apr 2017Drug	CLASS III	Fluocinolone Acetonide Topical Solution recalled by Novel LaboratoriesFluocinolone Acetonide	Novel Laboratories	Other	Nationwide
8 Jan 2014Drug	CLASS III	G & W Fluocinolone Acetonide Cream USP 0.025%, 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.