CLASS III Drug recall · Reported 27 Nov 2013 · FDA Enforcement Report

Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil recalled

Hill Dermaceuticals is recalling Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil (Body Oil), distributed nationwide in the US. The recall was initiated on 8 Sep 2013 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesK111100 exp.10/13, K111110 exp.10/13, M111240 exp.12/13, and A120012 exp.01/14

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-008-2014
FDA event ID: 66371
Recalling firm: Hill Dermaceuticals, Sanford, FL
Classification: Class III
Status: Terminated
Recall initiated: 8 Sep 2013
FDA classified: 20 Nov 2013
Reported: 27 Nov 2013
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Potency & Assay
Drug class: Creams, Ointments & Gels

Timeline

8 Sep 2013	Recall initiated by company
20 Nov 2013	Classified by FDA	+73 days
27 Nov 2013	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil (Body Oil), 118.28 mL (4 fl. oz.) bottle, Rx only, Manufactured and Distributed by: Hill Dermaceuticals, Inc., Sanford, Florida 32773, NDC 28105-150-04.

Where it was distributed

Nationwide and Puerto Rico.

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.

Which lots are affected?

K111100 exp.10/13, K111110 exp.10/13, M111240 exp.12/13, and A120012 exp.01/14

Where was it sold?

Nationwide and Puerto Rico.

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 66371

Reported	Class	Recall	Company	Reason	Where
27 Nov 2013	CLASS III	Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil recalled	Hill Dermaceuticals	Potency & Assay	Nationwide

More recalls from Hill Dermaceuticals

All 17

Reported	Class	Recall	Company	Reason	Where
30 Jun 2021Drug	CLASS II	DermOtic Oil (fluocinolone acetonide oil) 0.01% Ear Drops recalledDermotic	Hill Dermaceuticals	Foreign Material	Nationwide
2 Apr 2014Drug	CLASS III	Royal Pharmaceuticals Derma-Smoothe/FS fluocinolone recalledDerma-smoothe/fs	Hill Dermaceuticals	Potency & Assay	Nationwide
2 Apr 2014Drug	CLASS III	Seton Pharmaceuticals Fluocinolone Acetonide 0.01% Topical recalled	Hill Dermaceuticals	Potency & Assay	Nationwide
2 Apr 2014Drug	CLASS III	Royal Pharmaceuticals Derma-Smoothe/FS fluocinolone recalledDerma-smoothe/fs	Hill Dermaceuticals	Potency & Assay	Nationwide
2 Apr 2014Drug	CLASS III	DermOtic Oil (fluocinolone acetonide) 0.01% Ear Drops recalled	Hill Dermaceuticals	Potency & Assay	Nationwide

Other Derma-smoothe recalls

All 8

Reported	Class	Recall	Company	Reason	Where
2 Apr 2014Drug	CLASS III	Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil recalled	Hill Dermaceuticals	Potency & Assay	Nationwide
2 Apr 2014Drug	CLASS III	Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Body Oil) recalled	Hill Dermaceuticals	Potency & Assay	Nationwide
27 Nov 2013Drug	CLASS III	Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil recalled	Hill Dermaceuticals	Potency & Assay	Nationwide
3 Jul 2013Drug	CLASS III	Derma-Smoothe/FS (fluocinolone acetonide) Topical Oil recalled	Hill Dermaceuticals	Potency & Assay	Nationwide
3 Apr 2013Drug	CLASS III	Derma-Smoothe/FS (fluocinolone acetonide) recalled	Hill Dermaceuticals	Potency & Assay	Nationwide