Use cautionDrug recall · FDA · Published May 7, 2013
Hill Dermaceuticals Recalls Derma-Smoothe/FS Scalp Oil Due to Subpotency
Hill Dermaceuticals recalls Derma-Smoothe/FS scalp oil because the active ingredient was found to be subpotent. Check your lot number and expiration date.
Hill Dermaceuticals, Inc. is recalling Derma-Smoothe/FS (fluocinolone acetonide) Topical Oil because testing showed the active ingredient was subpotent. This means the medication may not work as intended to treat scalp conditions. The recall affects 8,808 bottles distributed nationwide and in Puerto Rico. Read more at govinfonow.com/recall/47932-hill-dermaceuticals-inc-recalls-derma-smoothe-fs-fluocinolone-acetonide-topical.
“Hill Dermaceuticals Recalls Derma-Smoothe/FS Scalp Oil Due to Subpotency.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/47932-hill-dermaceuticals-inc-recalls-derma-smoothe-fs-fluocinolone-acetonide-topical. Based on FDA recall #D-610-2013 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-610-2013%22&limit=1).
The FDA announced on May 7, 2013, that Hill Dermaceuticals, Inc. is recalling Derma-Smoothe/FS Scalp Oil due to subpotent drug risks. The agency classified the recall as Class III.
How to tell if you have it
Brand: Hill Dermaceuticals
Product: Derma-Smoothe/FS Scalp Oil
NDC: 28105-149-04
Lot #: H110940
Expiration: 08/13
The hazard
The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing. The FDA classified this as a Class III recall.
Context
GovInfoNow's records show Hill Dermaceuticals, Inc. has 5 other recalls on record since May 8, 2012. Other recent recalls of similar products include Hill Derm recalls DermOtic Oil Ear Drops (May 21, 2021), Hill Dermaceuticals, Inc. recalls ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% (January 31, 2014), and Hill Dermaceuticals Recalls Derma-Smoothe/FS Due to Subpotent Drug (September 8, 2013). 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 if you have Derma-Smoothe/FS Topical Oil, 0.01%, in an 118.28 mL (4 Fl. oz.) bottle with NDC 28105-149-04. The recalled lot number is H110940 with an expiration date of 08/13.
Brand
Hill Dermaceuticals
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Your Product Details
Verify if your bottle matches the NDC 28105-149-04 and lot number H110940 with expiration 08/13.
Consult Your Healthcare Provider
Contact your doctor or pharmacist to discuss alternative treatments since the remedy details are not provided in this record.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
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 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-610-2013 (May 7, 2013) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-610-2013 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.