Derma-Smoothe/FS — Class III drug recall D-1646-2012
Terminated recall by Hill Dermaceuticals, Inc., reported 2012-08-22, distributed nationwide. Subpotent; fluocinolone acetonide
| Recall number | D-1646-2012 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hill Dermaceuticals, Inc., Sanford, FL, United States |
| Recall initiated | 2012-05-08 |
| Classified | 2012-08-14 |
| Reported by FDA | 2012-08-22 |
| Terminated | 2015-02-10 |
| Distributed | Nationwide (US) |
| Quantity | 161,064 bottles |
| Reason classes | potency |
| NDC | 28105-0149-04 |
Product
Derma-Smoothe/FS (Fluocinolone Acetonide) 0.01% Topical Oil (Scalp Oil), 4 fl oz (118.28mL) bottle, Rx only, FOR TOPICAL USE ONLY NOT, Manufactured and Distributed by: Hill Dermaceuticals, Inc. SANFORD, FLORIDA --- NDC 28105-149-04
Reason for recall
Subpotent; fluocinolone acetonide
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-1646-2012. 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.