Seton Fluocinolone Scalp Oil Recall: Subpotent Drug Hazard
Seton Pharmaceuticals recalls 4,142 bottles of fluocinolone acetonide scalp oil due to subpotent active ingredients. Check your NDC and expiration date.
Use caution until it’s fixed
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Contact the company
What happened, in plain English
Seton Pharmaceuticals is recalling Fluocinolone acetonide 0.01% Topical Oil because routine testing found the active ingredient was subpotent. This means the medication may not work as intended for treating scalp conditions. The recall affects 4,142 bottles distributed nationwide and in Puerto Rico. Read more at govinfonow.com/recall/46272-hill-dermaceuticals-inc-recalls-seton-pharmaceuticals-fluocinolone-acetonide-0-01.
Source Summary by GovInfoNow · govinfonow.com/recall/46272-hill-dermaceuticals-inc-recalls-seton-pharmaceuticals-fluocinolone-acetonide-0-01 · Updated October 13, 2026 · FDA enforcement record: FDA #D-1179-2014
Cite this page
“Seton Fluocinolone Scalp Oil Recall: Subpotent Drug Hazard.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/46272-hill-dermaceuticals-inc-recalls-seton-pharmaceuticals-fluocinolone-acetonide-0-01. Based on FDA recall #D-1179-2014 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1179-2014%22&limit=1).
Why it’s dangerous
The active ingredient, fluocinolone acetonide, was found to be subpotent during routine testing. This means the concentration of the drug is lower than labeled, potentially rendering it ineffective for its intended medical use without posing a direct physical injury hazard like toxicity or burns.
Who’s affected
Consumers who purchased Seton Pharmaceuticals Fluocinolone acetonide 0.01% Topical Oil (Scalp Oil) between the manufacturing date and January 31, 2014. Individuals relying on this prescription for scalp conditions are at risk of receiving ineffective treatment.
How to tell if you have this one
Look for bottles containing Fluocinolone acetonide 0.01% Topical Oil (Scalp Oil), 4 fl.oz., Rx only. Check the label for NDC 13925-507-04 and lot number 13F015C with an expiration date of 12/14. The product was manufactured by Hill Dermaceuticals, Inc.
- Brand
Seton Pharmaceuticals- Category
Drug
All 9 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 | NDC |
|---|---|---|---|
| D-1173-2014 | DermOtic Oil (fluocinolone acetonide) 0.01% Ear Drops, 20 mL bottle, Rx only Manufactured and Distributed by: Hill Dermaceuticals, Inc. Sanford, Florida 32773 NDC 28105-160-20; 12H028B exp. 01/14 | 4,080 bottles | — |
| D-1174-2014 | Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Scalp Oil), 4 fl. oz., Rx only. Manufactured and Distributed by: Hill Dermaceuticals, Inc. Sanford, Florida 32773 NDC 28105-149-04; 12J030C exp. 03/14, 12L041C exp. 05/14 | 14,226 bottles | — |
| D-1175-2014 | Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Body Oil) 4 fl. oz., Rx only Manufactured and Distributed by: Hill Dermaceuticals, Inc. Sanford, Florida 32773 NDC 28105-150-04; 13D010A exp. 10/14. | 8,734 bottles | — |
| D-1176-2014 | ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Body Oil) 4 fl. oz., Rx only Manufactured by: Hill Dermaceuticals, Inc. for: Royal Pharmaceuticals NDC 68791-101-04; 13E013A exp. 11/14. | 8,734 bottles | 68791-101-04, 68791-101-01 |
| D-1177-2014 | ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% (Scalp Oil), 4 fl.oz., Rx only Manufactured by: Hill Dermaceuticals for: Royal Pharmaceuticals NDC 68791-102-04; 13E014A exp. 11/14, 13F02C exp 12/14. | 7,292 bottles | 68791-102-04, 68791-102-01 |
| D-1178-2014 | ROYAL PHARMACEUTICALS DermOtic Oil fluocinolone acetonide 0.01% (Ear Drops), 20 ml, Rx only Manufactured by: Hill Dermaceuticalsfor: Royal Pharmaceuticals NDC 68791-103-20; 13F015B exp. 12/14, 13G023B exp. 01/15 | 13,379 bottles | 68791-103-20 |
| D-1179-2014 | SETON PHARMACEUTICALS Fluocinolone acetonide 0.01% Topical Oil (Scalp Oil), 4 fl.oz., Rx only Manufactured by: Hill Dermaceuticals, Inc. For: Seton Pharmaceuticals NDC 13925-507-04; 13F015C exp. 12/14. | 4,142 bottles | — |
| D-1180-2014 | SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Topical Oil (Body Oil), 4 fl.oz., Rx only Manufactured by: Hill Dermaceuticals, Inc. For: Seton Pharmaceuticals NDC 13925-506-04; 13F016A exp. 12/14. | 7,676 bottles | — |
| D-1181-2014 | SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Oil EAR DROPS, 20 ml, Rx only Manufactured by: Hill Dermaceuticals, Inc. For: Seton Pharmaceuticals NDC 13925-508-20; 13F017B exp. 12/14, 13F020B exp 12/14 | 13,591 bottles | — |
What to do — step by step
Check Your Product Details
Verify if you have the recalled Seton Pharmaceuticals scalp oil by checking for NDC 13925-507-04 and lot 13F015C exp. 12/14.
Consult Your Healthcare Provider
Contact your doctor or pharmacist to discuss alternative treatments since the remedy details are not specified in the 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 12 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.
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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-1179-2014 (January 31, 2014) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1179-2014 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.