Fluocinolone Acetonide recalls

The FDA has published 11 recalls involving Fluocinolone Acetonide since 2014. The latest was reported on 21 Jan 2026. Most were for potency & assay. Lyne Laboratories 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 recalls11since 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 7 64%Class III 4 36%

Why fluocinolone acetonide is recalled

Companies

Brands

By year

202619%
202119%
201919%
2018545%
201719%
2014218%

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

11 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 Jun 2021Drug	CLASS II	DermOtic Oil (fluocinolone acetonide oil) 0.01% Ear Drops recalledDermotic	Hill Dermaceuticals	Foreign Material	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
18 Jul 2018Drug	CLASS II	Fluocinolone Acetonide Topical Solution recalledFluocinolone Acetonide Topical	Teva Pharmaceuticals USA	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
2 Apr 2014Drug	CLASS III	Royal Pharmaceuticals DermOtic Oil fluocinolone acetonide recalledDermotic	Hill Dermaceuticals	Potency & Assay	Nationwide
8 Jan 2014Drug	CLASS III	G & W Fluocinolone Acetonide Cream USP 0.025%, a) 15 gm recalledFluocinolone Acetonide	G & W Laboratories	Other	Nationwide

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.

Alert me about Fluocinolone Acetonide

One email the day a new recall is posted for Fluocinolone Acetonide. Unsubscribe any time.

At a glance

Latest recall: 21 Jan 2026
First on record: 8 Jan 2014
Class I share: 0%
Ongoing: 1

Drug classes

Injectable & IV Drugs 4,641Pain Medication 1,519Creams, Ointments & Gels 937Blood Pressure Medication 839Compounded Drugs 722Eye Drops 606Hormones & Birth Control 495Antibiotics 491Allergy Medication 348Stomach & Acid Reflux Medication 317Cold & Cough Medicine 312Diabetes Medication 252

Recall classes

CLASS ISerious harm or death possible.

CLASS IITemporary or reversible harm.

CLASS IIIUnlikely to cause harm.