Hill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Topical Oil
Hill Dermaceuticals is recalling 14,226 bottles of Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil because the active ingredient was found to be subpotent during routine testing.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which by definition indicates that use of the product is not likely to cause adverse health consequences, aligning with the 'Low' severity criteria for documentation or minor issues.
Plain-English summary
Hill Dermaceuticals, Inc. is recalling 14,226 bottles of Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Scalp Oil), 4 fl. oz., prescription only. The product was distributed nationwide and in Puerto Rico. The recall involves specific lot codes 12J030C (expiration 03/14) and 12L041C (expiration 05/14).
The recall was initiated because the active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing. A subpotent drug contains less of the active ingredient than labeled, which may result in a lack of therapeutic effect for the patient.
Consumers and healthcare providers should stop using the affected product and return it to the pharmacy or point of purchase for a refund or replacement. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
The recalled product
- Product
- 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
- Manufacturer
- Hill Dermaceuticals, Inc.
- Category
- Drug — Topical Corticosteroid
- Hazard
- Affected units
- 14,226
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 (2)
- 12J030C exp. 03/14
- 12L041C exp. 05/14
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
- ModerateHill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Topical 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 Topical Oil
FDA (Drugs) · 2014-04-02
- ModerateHill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide 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