Use caution Drug recall · FDA · Published September 8, 2013

Hill Dermaceuticals Recalls Derma-Smoothe/FS Due to Subpotent Drug

Hill Dermaceuticals recalls Derma-Smoothe/FS topical oil because the active ingredient was found to be subpotent. Check lot numbers and expiration dates.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-008-2014Drug Hill Dermaceuticals ›

Use caution until it’s fixed

Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.

Take action

Contact the company

Recalling firmHill Dermaceuticals, Inc.2650 S Mellonville Ave · Sanford, FL 32773-9311

✎ GovInfoNow plain-language explainer

Hill Dermaceuticals, Inc. is recalling Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil because routine testing revealed the active ingredient was subpotent. This means the medication may not work as intended for treating skin conditions. The recall affects specific lots distributed nationwide and in Puerto Rico. Read more at govinfonow.com/recall/46626-hill-dermaceuticals-inc-recalls-derma-smoothe-fs-fluocinolone-acetonide-0.

Source Summary by GovInfoNow · govinfonow.com/recall/46626-hill-dermaceuticals-inc-recalls-derma-smoothe-fs-fluocinolone-acetonide-0 · Updated October 13, 2026 · FDA enforcement record: FDA #D-008-2014

Cite this page

“Hill Dermaceuticals Recalls Derma-Smoothe/FS Due to Subpotent Drug.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/46626-hill-dermaceuticals-inc-recalls-derma-smoothe-fs-fluocinolone-acetonide-0. Based on FDA recall #D-008-2014 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-008-2014%22&limit=1).

The FDA announced on 2013-09-08 that Hill Dermaceuticals, Inc. is recalling Derma-Smoothe/FS Topical Oil due to subpotent active ingredients. The agency classified the Class III recall as voluntary.

How to tell if you have it

Brand: Hill Dermaceuticals
Product: Derma-Smoothe/FS Topical Oil
NDC: 28105-150-04
Lot codes: K111100, K111110, M111240, A120012
Expiration dates: 10/13, 12/13, 01/14

The hazard

The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing. The FDA said this constitutes a Subpotent Drug hazard.

Context

GovInfoNow's records show Hill Dermaceuticals, Inc. has 5 other recalls on record since 2012-05-08. Other recent recalls of similar products include CoValence Laboratories Skin Rehab Gel Recall (2026-03-18), CoValence Laboratories Remedy Gel Hydrocortisone 1% Recall (2026-03-18), and Sun Pharmaceutical Fluocinolone Acetonide Solution Recall (2025-12-30).

How to tell if you have this one

Check your bottle for the NDC 28105-150-04 and one of the following lot numbers with expiration dates: K111100 (exp. 10/13), K111110 (exp. 10/13), M111240 (exp. 12/13), or A120012 (exp. 01/14). The product is an 118.28 mL (4 fl. oz.) Rx-only bottle.

Brand
Hill Dermaceuticals
Category
Drug

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class III
Status
Terminated
Distribution
Nationwide and Puerto Rico.

Recall number	Product, codes & lots	Quantity
D-007-2014	Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil (Scalp Oil), 118.28 mL (4 Fl. oz.) bottle, Rx only, Manufactured and Distributed by: Hill Dermaceuticals, Inc., Sanford, Florida 32773, NDC 28105-149-04.; K111090 exp.10/13, K111122 exp10/13, K111140 exp.10/13, K111150 exp.10/13, 111180 exp.11/13, L111190 exp11/13, M111250 exp.12/13, M111270 exp.12/13, and M111292 exp.12/13	—
D-008-2014	Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil (Body Oil), 118.28 mL (4 fl. oz.) bottle, Rx only, Manufactured and Distributed by: Hill Dermaceuticals, Inc., Sanford, Florida 32773, NDC 28105-150-04.; K111100 exp.10/13, K111110 exp.10/13, M111240 exp.12/13, and A120012 exp.01/14	—

Based on the official FDA remedy

What to do — step by step

Check Your Bottle
Verify if your Derma-Smoothe/FS bottle matches the recalled lot numbers and expiration dates listed in the recall record.
Consult Your Doctor
Contact your healthcare provider to discuss alternative treatment options since the remedy details are not provided in this record.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide and Puerto Rico.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 11 months after the firm started it.

Sep 8, 2013Firm started the recall
Nov 20, 2013FDA classified it Class III
Nov 27, 2013Published in FDA’s Enforcement Report
Aug 4, 2014FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/46626-hill-dermaceuticals-inc-recalls-derma-smoothe-fs-fluocinolone-acetonide-0">Hill Dermaceuticals Recalls Derma-Smoothe/FS Due to Subpotent Drug (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-008-2014 (September 8, 2013) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-008-2014 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 13, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.