Hill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Topical Oil
Hill Dermaceuticals is recalling 8,734 bottles of Derma-Smoothe/FS 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 a low risk of adverse health consequences. The hazard is a lack of efficacy (subpotency) rather than a direct safety threat like toxicity or contamination.
Plain-English summary
Hill Dermaceuticals, Inc. is recalling 8,734 bottles of Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil. The product is a prescription-only body oil manufactured by Hill Dermaceuticals, Inc. for Royal Pharmaceuticals. The recall involves bottles with the code 13E013A and an expiration date of 11/14.
The recall was initiated because the active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing. This means the medication may not contain the full amount of the active ingredient required to be effective.
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 treatments or replacements.
The recalled product
- Product
- DERMA-SMOOTHE/FS (FLUOCINOLONE ACETONIDE)
- Brand
- DERMA-SMOOTHE/FS
- Manufacturer
- Hill Dermaceuticals, Inc.
- Category
- Drug — Topical Corticosteroid
- Hazard
- Affected units
- 8,734
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)
- 13E013A exp. 11/14.
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 brand · DERMA-SMOOTHE/FS
- LowHill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Scalp Oil
FDA (Drugs) · 2014-04-02
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 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