SETON PHARMACEUTICALS Fluocinolone Acetonide 0 — Class III drug recall D-1181-2014
Terminated recall by Hill Dermaceuticals, Inc., reported 2014-04-02, distributed nationwide. Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's rou
| Recall number | D-1181-2014 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hill Dermaceuticals, Inc., Sanford, FL, United States |
| Recall initiated | 2014-01-31 |
| Classified | 2014-03-24 |
| Reported by FDA | 2014-04-02 |
| Terminated | 2015-02-03 |
| Distributed | Nationwide (US) |
| Quantity | 13,591 bottles |
| Reason classes | potency |
| NDC | 13925-0508-20 |
Product
SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Oil EAR DROPS, 20 ml, Rx only Manufactured by: Hill Dermaceuticals, Inc. For: Seton Pharmaceuticals NDC 13925-508-20
Reason for recall
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
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-1181-2014. 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.