Xolegel Ketoconazole Gel Recalled Due to Failed Viscosity Specification
ALMIRALL, LLC is recalling 5,315 tubes of Xolegel ketoconazole 2% gel because tests found the product failed viscosity specifications, with out-of-specification results showing values slightly higher than acceptable.
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: This is an FDA Class III recall with no reported illnesses or injuries. The issue is a manufacturing specification failure where viscosity testing showed out-of-specification results slightly higher than the acceptable range. FDA Class III recalls are typically scored 1 or 2 per the severity rubric; the specification failure elevates this to Moderate rather than Low.
Plain-English summary
Xolegel is a prescription antifungal gel containing ketoconazole 2%, used to treat fungal skin infections. ALMIRALL, LLC is recalling 5,315 tubes (NDC 16110-080-45, manufactured by DPT Laboratories) because the product failed viscosity testing. Out-of-specification results showed viscosity values slightly higher than the acceptable range.
The affected product (Lot #RGAF, expiration date 12/2022) was distributed nationwide within the United States. The product is available by prescription only.
Consumers who have this product should consult their healthcare provider or pharmacist. Do not discontinue use without speaking to your doctor. Those with this lot can contact their pharmacy for a replacement or alternative antifungal treatment.
The recalled product
- Product
- Xolegel (ketoconazole) gel 2%, 45 gram tubes, Rx only, Manufactured by: DPT Laboratories, San Antonio, TX 78215, NDC 16110-080-45
- Manufacturer
- ALMIRALL, LLC
- Category
- Drug — Topical Antifungal
- Hazard
- Affected units
- 5,315
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 #: RGAF
- Exp. Date 12/2022
Distribution
Distributed nationwide across the United States.
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