CLASS II Drug recall · Reported 19 Nov 2014 · FDA Enforcement Report
Fluocinonide Gel recalled by Fougera Pharmaceuticals
Fougera Pharmaceuticals is recalling Fluocinonide Gel USP, 0.05%, distributed nationwide in the US. The recall was initiated on 28 Aug 2014 and the FDA has classified it as Class II.
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-0245-2015
- FDA event ID
- 68839
- Recalling firm
- Fougera Pharmaceuticals, Melville, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Aug 2014
- FDA classified
- 12 Nov 2014
- Reported
- 19 Nov 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Eye Drops
Timeline
| 28 Aug 2014 | Recall initiated by company | |
| 12 Nov 2014 | Classified by FDA | +76 days |
| 19 Nov 2014 | 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
Failed Stability Specifications: The lots of Fluocinonide Gel USP, 0.05% recalled, may not meet the requirements for residual solvents as outlined in USP <467>.
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
FLUOCINONIDE GEL USP, 0.05%, Rx only, For External Use Only, Not For Ophthalmic Use, a) NET WT 15 gram tubes and b) NET WT 60 grams tubes, E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0135-15 (15 g) and NDC 0168-0135-60 (60 g)
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
Failed Stability Specifications: The lots of Fluocinonide Gel USP, 0.05% recalled, may not meet the requirements for residual solvents as outlined in USP <467>.
Which lots are affected?
a) 15 gram lot numbers: 549N, 550N,551N Exp. 1/2015, EB1961, Exp. 2/2017; b) 60 gram lot numbers: 546N, 547N, 548N, Exp. 1/2015, EB0144, Exp. 2/2017
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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 Fougera Pharmaceuticals
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|---|---|---|---|---|---|
| Drug | CLASS II | Desonide Ointment recalled by Fougera Pharmaceuticals | Fougera Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS III | Triamcinolone Acetonide Lotion recalled by Fougera Pharmaceuticals | Fougera Pharmaceuticals | Other | Nationwide |
| Drug | CLASS III | Triamcinolone Acetonide Lotion recalled by Fougera Pharmaceuticals | Fougera Pharmaceuticals | Other | Nationwide |
| Drug | CLASS III | Triamcinolone Acetonide Cream recalled by Fougera PharmaceuticalsTriamcinolone Acetonide | Fougera Pharmaceuticals | Other | Nationwide |
| Drug | CLASS III | Ketoconazole Cream, 2% tube recalled by Fougera PharmaceuticalsKetoconazole | Fougera Pharmaceuticals | Potency & Assay | Nationwide |
Other Fluocinonide recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Fluocinonide, USP, 0.05% Cream tube recalledFluocinonide | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Fluocinonide, USP, 0.05% Cream tube recalledFluocinonide | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Fluocinonide, USP, 0.05% Cream tube recalledFluocinonide | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Fluocinonide Topical Solution recalled by Teligent Pharma | Teligent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Fluocinonide Gel recalled by Teligent Pharma | Teligent Pharma | Potency & Assay | Nationwide |