CLASS III Drug recall · Reported 22 Aug 2012 · FDA Enforcement Report

Derma-Smoothe/FS (Fluocinolone Acetonide) 0.01%, Body Oil ) recalled

Hill Dermaceuticals is recalling Derma-Smoothe/FS (Fluocinolone Acetonide) 0.01%, Body Oil ), distributed nationwide in the US. The recall was initiated on 8 May 2012 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot Numbers: -Body Oil: J100095 (exp 09/12), J100099 (exp 09/12), K100106 (exp 10/12), K100111 (exp 10/12), L100872 (exp 11/12), L100880 (exp 11/12), D110560 (exp 04/13).

Quantity recalled111,816 bottles

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-1647-2012
FDA event ID: 62607
Recalling firm: Hill Dermaceuticals, Sanford, FL
Classification: Class III
Status: Terminated
Recall initiated: 8 May 2012
FDA classified: 14 Aug 2012
Reported: 22 Aug 2012
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 May 2012	Recall initiated by company
14 Aug 2012	Classified by FDA	+98 days
22 Aug 2012	Published in enforcement report	+8 days

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

Reason for recall

Subpotent; fluocinolone acetonide

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%, Body Oil, 4 fl. oz. (118.28mL ), Rx only, FOR TOPICAL USE ONLY, Manufactured and Distributed by: Hill Dermaceuticals, Inc. SANFORD, FLORIDA --- NDC 28105-150-04

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Subpotent; fluocinolone acetonide

Which lots are affected?

Lot Numbers: -Body Oil: J100095 (exp 09/12), J100099 (exp 09/12), K100106 (exp 10/12), K100111 (exp 10/12), L100872 (exp 11/12), L100880 (exp 11/12), D110560 (exp 04/13).

Where was it sold?

Nationwide

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 62607

This product is part of a recall event; the main page for the event is Derma-Smoothe/FS (Fluocinolone Acetonide) 0.01% Topical Oil recalled.

Reported	Class	Recall	Company	Reason	Where
22 Aug 2012	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