FLUOCINONIDE GEL USP — Class II drug recall D-0245-2015
Terminated recall by Fougera Pharmaceuticals Inc., reported 2014-11-19, distributed nationwide. Failed Stability Specifications: The lots of Fluocinonide Gel USP, 0.05% recalled, may not meet the requiremen
| Recall number | D-0245-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fougera Pharmaceuticals Inc., Melville, NY, United States |
| Recall initiated | 2014-08-28 |
| Classified | 2014-11-12 |
| Reported by FDA | 2014-11-19 |
| Terminated | 2016-06-21 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 00168-0135-15, 00168-0135-60 |
| Lot numbers | 546N, 547N, 548N, 549N, 550N, 551N, EB0144, EB1961 |
| Expiration dates | 2015-01, 2017-02 |
Product
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)
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>.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0245-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.