Hill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Topical Oil
Hill Dermaceuticals is recalling 4,142 bottles of Fluocinolone acetonide 0.01% Topical Oil because the active ingredient was found to be subpotent during routine testing.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The hazard is a lack of therapeutic effect due to subpotency, which aligns with the Moderate severity criteria for low-risk issues.
Plain-English summary
Hill Dermaceuticals, Inc. is recalling 4,142 bottles of Fluocinolone acetonide 0.01% Topical Oil (Scalp Oil), 4 fl.oz., manufactured for Seton Pharmaceuticals. The product is identified by NDC 13925-507-04 and lot code 13F015C with an expiration date of 12/14.
The recall was initiated because the active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing. Subpotent drugs contain less of the active ingredient than labeled, which may result in a lack of therapeutic effect for the patient.
The affected product was distributed nationwide and in Puerto Rico. Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on alternative treatment options.
The recalled product
- Product
- 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
- Manufacturer
- Hill Dermaceuticals, Inc.
- Category
- Drug — Topical Steroid
- Hazard
- Affected units
- 4,142
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 13F015C exp. 12/14.
Distribution
Part of a larger recall action
This product is one of 9 recalled by Hill Dermaceuticals, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 9 products in this recall →Related recalls
Same manufacturer · Hill Dermaceuticals, Inc.
See all →- HighDermOtic fluocinolone acetonide ear drops recalled for broken glass risk
FDA (Drugs) · 2021-06-30
- LowHill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Scalp Oil
FDA (Drugs) · 2014-04-02
- ModerateHill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Topical Oil
FDA (Drugs) · 2014-04-02
- ModerateHill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Ear Drops
FDA (Drugs) · 2014-04-02
- ModerateHill Dermaceuticals Recalls Subpotent Dermotic Ear Drops
FDA (Drugs) · 2014-04-02
Same hazard · subpotent drug
See all →- ModerateAccord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
- HighAccord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
- SevereAccord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
- HighAccord Healthcare Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
- HighAccord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02