CLASS III Drug recall · Reported 3 Jul 2013 · FDA Enforcement Report
Derma-Smoothe/FS (fluocinolone acetonide) Topical Oil recalled
Hill Dermaceuticals is recalling Derma-Smoothe/FS (fluocinolone acetonide) Topical Oil (Scalp OIL), 0.01 %, distributed nationwide in the US. The recall was initiated on 7 May 2013 and the FDA has classified it as Class III.
Check your package
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-610-2013
- FDA event ID
- 65434
- Recalling firm
- Hill Dermaceuticals, Sanford, FL
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 7 May 2013
- FDA classified
- 21 Jun 2013
- Reported
- 3 Jul 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Creams, Ointments & Gels
Timeline
| 7 May 2013 | Recall initiated by company | |
| 21 Jun 2013 | Classified by FDA | +45 days |
| 3 Jul 2013 | Published in enforcement report | +12 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) Topical Oil (SCALP OIL), 0.01 %, 118.28 mL (4 Fl. oz.) bottle, Rx only, Manufactured and Distributed by: Hill Dermaceuticals, Inc. SANFORD, FLORIDA 32773; NDC 28105-149-04.
Where it was distributed
Nationwide and 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?
Lot #: H110940, Exp 08/13
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.
More recalls from Hill Dermaceuticals
All 17| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | DermOtic Oil (fluocinolone acetonide oil) 0.01% Ear Drops recalledDermotic | Hill Dermaceuticals | Foreign Material | Nationwide |
| Drug | CLASS III | Royal Pharmaceuticals Derma-Smoothe/FS fluocinolone recalled | Hill Dermaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Seton Pharmaceuticals Fluocinolone Acetonide 0.01% Topical recalled | Hill Dermaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Royal Pharmaceuticals Derma-Smoothe/FS fluocinolone recalled | Hill Dermaceuticals | Potency & Assay | Nationwide |
| Drug | 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 |
|---|---|---|---|---|---|
| Drug | CLASS III | Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil recalled | Hill Dermaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Body Oil) recalled | Hill Dermaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil recalled | Hill Dermaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil recalled | Hill Dermaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Derma-Smoothe/FS (fluocinolone acetonide) recalled | Hill Dermaceuticals | Potency & Assay | Nationwide |