CLASS III Drug recall · Reported 2 Apr 2014 · FDA Enforcement Report
Royal Pharmaceuticals Derma-Smoothe/FS fluocinolone recalled
Hill Dermaceuticals is recalling Royal Pharmaceuticals Derma-Smoothe/FS fluocinolone acetonide 01% (Scalp Oil), distributed nationwide in the US. The recall was initiated on 31 Jan 2014 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-1177-2014
- FDA event ID
- 67420
- Recalling firm
- Hill Dermaceuticals, Sanford, FL
- Brand
- Derma-smoothe/fs
- Manufacturer
- Royal Pharmaceuticals
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 31 Jan 2014
- FDA classified
- 24 Mar 2014
- Reported
- 2 Apr 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Potency & Assay
Timeline
| 31 Jan 2014 | Recall initiated by company | |
| 24 Mar 2014 | Classified by FDA | +52 days |
| 2 Apr 2014 | Published in enforcement report | +9 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
ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% (Scalp Oil), 4 fl.oz., Rx only Manufactured by: Hill Dermaceuticals for: Royal Pharmaceuticals NDC 68791-102-04
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Is Royal Pharmaceuticals Derma-Smoothe/FS fluocinolone acetonide 01% (Scalp Oil) recalled?
Yes. Hill Dermaceuticals recalled Royal Pharmaceuticals Derma-Smoothe/FS fluocinolone acetonide 01% (Scalp Oil) on 31 Jan 2014. The recall is Class III and its status is Terminated. Recall number D-1177-2014.
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?
13E014A exp. 11/14, 13F02C exp 12/14.
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 21 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) 01% Ear Drops recalledDermotic | Hill Dermaceuticals | Foreign Material | Nationwide |
| Drug | CLASS III | Seton Pharmaceuticals Fluocinolone Acetonide 01% Topical recalled | Hill Dermaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Royal Pharmaceuticals Derma-Smoothe/FS fluocinolone recalledDerma-smoothe/fs | Hill Dermaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | DermOtic Oil (fluocinolone acetonide) 01% Ear Drops recalled | Hill Dermaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Derma-Smoothe/FS fluocinolone acetonide 01% Topical Oil (Scalp Oil) recalled | Hill Dermaceuticals | Potency & Assay | Nationwide |
Other Fluocinolone Acetonide recalls
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Fluocinolone Acetonide Solution Topical Solution recalledFluocinolone Acetonide | Sun Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Fluocinolone Acetonide Oil, 01% (Ear Drops), package in fill volume) recalledFluocinolone Acetonide | Glenmark Pharmaceuticals Inc., U | Potency & Assay | Nationwide |
| Drug | CLASS II | DermOtic Oil (fluocinolone acetonide oil) 01% Ear Drops recalledDermotic | Hill Dermaceuticals | Foreign Material | Nationwide |
| Drug | CLASS II | Fluocinolone Acetonide Topical Solution, USP, 01 % recalledFluocinolone Acetonide | Lupin Somerset | Potency & Assay | Nationwide |
| Drug | CLASS II | Fluocinolone Acetonide Topical Solution recalled by Lupin SomersetFluocinolone Acetonide | Lupin Somerset | Potency & Assay | Nationwide |