Derma-Smoothe/FS — Class III drug recall D-610-2013
Terminated recall by Hill Dermaceuticals, Inc., reported 2013-07-03, distributed nationwide. Subpotent Drug: the active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's rou
| Recall number | D-610-2013 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hill Dermaceuticals, Inc., Sanford, FL, United States |
| Recall initiated | 2013-05-07 |
| Classified | 2013-06-21 |
| Reported by FDA | 2013-07-03 |
| Terminated | 2013-07-19 |
| Distributed | Nationwide (US) |
| Quantity | 8,808 bottles |
| Reason classes | potency |
| NDC | 28105-0149-04 |
| Lot numbers | 08/13, H110940 |
Product
Derma-Smoothe/FS (fluocinolone acetonide) Topical Oil (SCALP OIL), 0.01 %, 118.28 mL (4 Fl. oz.) bottle, Rx only, Manufactured and Distributed by: Hill Dermaceuticals, Inc. SANFORD, FLORIDA 32773; NDC 28105-149-04.
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-610-2013. 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.