Hill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Topical Oil
Hill Dermaceuticals is recalling 8,592 bottles of Derma-Smoothe/FS topical oil because the product was found to be subpotent at a 22-month stability timepoint.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 violation of labeling or the FD&C Act that is not likely to cause adverse health consequences. The hazard is a lack of efficacy (subpotency) rather than a direct safety risk like toxicity or infection.
Plain-English summary
Hill Dermaceuticals, Inc. is recalling 8,592 bottles of Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil. The product is a prescription-only scalp oil with a net content of 118.28 mL (4 fl. oz.). The specific lot affected is # D110550, with an expiration date of 04/2013.
The recall was initiated because the product was found to be subpotent at a 22-month stability timepoint. This means the medication may not contain the full amount of the active ingredient, fluocinolone acetonide, required to treat the condition it is prescribed for.
The affected product was distributed nationwide. Consumers and healthcare providers should stop using the recalled product and return it to the pharmacy or point of purchase for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if necessary.
The recalled product
- Product
- 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
- Manufacturer
- Hill Dermaceuticals, Inc.
- Category
- Drug — Topical Corticosteroid
- Hazard
- Affected units
- 8,592
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)
- Lot # D110550
- Exp. 04/2013.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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.
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