Use caution Drug recall · FDA · Published May 8, 2012

Hill Dermaceuticals Recalls Derma-Smoothe/FS Scalp Oil Due to Subpotency

Hill Dermaceuticals recalls Derma-Smoothe/FS topical oil because it may be subpotent. Check lot numbers and expiration dates for affected batches.

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

🇺🇸 FDA recall #D-1646-2012Drug Hill Dermaceuticals ›

Use caution until it’s fixed

Subpotent; fluocinolone acetonide

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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 the product may be subpotent, meaning it might not contain enough of the active ingredient to work as intended. The recall affects approximately 161,064 bottles distributed nationwide. No remedy or specific action steps are currently listed in the record. Read more at govinfonow.com/recall/48892-hill-dermaceuticals-inc-recalls-derma-smoothe-fs-fluocinolone-acetonide-0.

Source Summary by GovInfoNow · govinfonow.com/recall/48892-hill-dermaceuticals-inc-recalls-derma-smoothe-fs-fluocinolone-acetonide-0 · Updated October 13, 2026 · FDA enforcement record: FDA #D-1646-2012

Cite this page

“Hill Dermaceuticals Recalls Derma-Smoothe/FS Scalp Oil Due to Subpotency.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/48892-hill-dermaceuticals-inc-recalls-derma-smoothe-fs-fluocinolone-acetonide-0. Based on FDA recall #D-1646-2012 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1646-2012%22&limit=1).

The FDA announced on May 8, 2012, that Hill Dermaceuticals, Inc. voluntarily recalled Derma-Smoothe/FS Scalp Oil due to subpotent fluocinolone acetonide levels. The recall affects 161,064 bottles distributed nationwide.

How to tell if you have it

Brand: Hill Dermaceuticals
Product: Derma-Smoothe/FS Scalp Oil
NDC: 28105-149-04
Lot Numbers: H100084, H100086, J100093, J100094, J100097, K100101, K100103, K100104, K100108, K100112, L100860, L100890, L100910
Quantity: 161,064 bottles

The hazard

The product contains subpotent fluocinolone acetonide. The FDA classified this as a Class III recall.

Context

GovInfoNow's records show Hill Dermaceuticals, Inc. has issued five other recalls since November 21, 2012. Other recent recalls of similar products include CoValence Laboratories Remedy Gel Hydrocortisone 1% Recall (March 18, 2026), CoValence Laboratories Skin Rehab Gel Recall (March 18, 2026), and Sun Pharmaceutical Fluocinolone Acetonide Solution Recall (December 30, 2025).

How to tell if you have this one

Check your bottle for the NDC number 28105-149-04 and look at the lot numbers printed on the packaging. Affected lots include H100084, H100086, J100093, J100094, J100097, K100101, K100103, K100104, K100108, K100112, L100860, L100890, and L100910. Verify the expiration dates associated with these lots, which range from August 2012 to November 2012.

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

Recall number	Product, codes & lots	Quantity
D-1646-2012	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; Lot Numbers: -Scalp Oil: H100084 (exp 08/12), H100086 (08/12), J100093 (exp 08/12), J100094 (exp 09/12), J100097 (exp 09/12), K100101 (exp 09/12), K100103 (exp 10/12), K100104 (exp 10/12), K100108 (exp 10/12), K100112 (exp 10/12), L100860 (exp 11/12), L100890 (exp 11/12), L100910 (exp 11/12).	161,064 bottles
D-1647-2012	Derma-Smoothe/FS (Fluocinolone Acetonide) 0.01%, Body Oil, 4 fl. oz. (118.28mL ), Rx only, FOR TOPICAL USE ONLY, Manufactured and Distributed by: Hill Dermaceuticals, Inc. SANFORD, FLORIDA --- NDC 28105-150-04; Lot Numbers: -Body Oil: J100095 (exp 09/12), J100099 (exp 09/12), K100106 (exp 10/12), K100111 (exp 10/12), L100872 (exp 11/12), L100880 (exp 11/12), D110560 (exp 04/13).	111,816 bottles

Where it went and when

Where it was distributed

Distributed nationwide.

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

Distributed nationwide.

Recall timeline

FDA terminated this recall 2.8 years after the firm started it.

May 8, 2012Firm started the recall
Aug 14, 2012FDA classified it Class III
Aug 22, 2012Published in FDA’s Enforcement Report
Feb 10, 2015FDA 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/48892-hill-dermaceuticals-inc-recalls-derma-smoothe-fs-fluocinolone-acetonide-0">Hill Dermaceuticals Recalls Derma-Smoothe/FS Scalp Oil Due to Subpotency (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-1646-2012 (May 8, 2012) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1646-2012 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.