Hill Dermaceuticals Recalls Derma-Smoothe/FS Scalp Oil Due to Subpotency
Hill Dermaceuticals recalls Derma-Smoothe/FS scalp oil because it may be subpotent. Check lot D110550 and expiration date 04/2013 for details.
Use caution until it’s fixed
Subpotent; 22 month stability timepoint
Contact the company
What happened, in plain English
Hill Dermaceuticals, Inc. is recalling Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil because the product may be subpotent at the 22-month stability timepoint. This means the medication might not contain enough active ingredient to work as intended. The recall affects 8,592 bottles distributed nationwide. Read more at govinfonow.com/recall/48476-hill-dermaceuticals-inc-recalls-derma-smoothe-fs-fluocinolone-acetonide-0.
Source Summary by GovInfoNow · govinfonow.com/recall/48476-hill-dermaceuticals-inc-recalls-derma-smoothe-fs-fluocinolone-acetonide-0 · Updated October 13, 2026 · FDA enforcement record: FDA #D-218-2013
Cite this page
“Hill Dermaceuticals Recalls Derma-Smoothe/FS Scalp Oil Due to Subpotency.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/48476-hill-dermaceuticals-inc-recalls-derma-smoothe-fs-fluocinolone-acetonide-0. Based on FDA recall #D-218-2013 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-218-2013%22&limit=1).
Why it’s dangerous
The primary hazard is that the drug is subpotent, meaning it contains less of the active ingredient than labeled. This could result in the treatment failing to manage the intended condition effectively. The record does not describe immediate physical injury risks like burns or allergic reactions.
Who’s affected
Consumers who purchased Derma-Smoothe/FS scalp oil between its manufacture and April 2013 are affected. Individuals relying on this prescription medication for scalp conditions may receive insufficient treatment.
How to tell if you have this one
Look for Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil, Net Contents 118.28 mL (4 fl. oz.). Check the label for NDC 28105-149-04, Lot # D110550, and an expiration date of 04/2013.
- Brand
Hill Dermaceuticals- Category
Drug
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-217-2013 | Derma-Smoothe/FS (fluocinolone acetonide), 0.01% Topical Oil (Body Oil), Rx only, Hill Dermaceuticals, Inc., Sanford, Florida 32773 --- NDC 28105-150-04; Lot J111040, Exp. (09/13) | 8,736 bottles |
| D-218-2013 | Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil(SCALP OIL), Rx only, FOR TOPICAL USE ONLY, NOT FOR ORAL, OPHTHALMIC, OR INTRAVAGINAL USE, Net Contents 118.28 mL (4 fl. oz.), Hill Dermaceuticals, Inc., Sanford, Florida --- NDC 28105-149-04; Lot # D110550, Exp. 04/2013. | 8,592 bottles |
What to do — step by step
Check Your Product Details
Verify if your bottle matches NDC 28105-149-04, Lot # D110550, and Exp. 04/2013.
Consult Your Healthcare Provider
Contact your doctor or pharmacist to discuss alternative treatments since the remedy is not stated in the record.
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 6 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
How many bottles are affected by this recall?
Approximately 8,592 bottles are included in this recall.
Similar recalls
Latest drug recalls
Keep exploring
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-218-2013 (November 21, 2012) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-218-2013 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.