Xolegel — Class III drug recall D-1549-2022
Terminated recall by ALMIRALL, LLC, reported 2022-10-05, distributed nationwide. Failed Viscosity specification: Slightly higher OOS results obtained for viscosity
| Recall number | D-1549-2022 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ALMIRALL, LLC, Malvern, PA, United States |
| Recall initiated | 2022-09-16 |
| Classified | 2022-09-29 |
| Reported by FDA | 2022-10-05 |
| Terminated | 2023-07-13 |
| Distributed | Nationwide (US) |
| Quantity | 5,315 tubes |
| Reason classes | specification failure |
| NDC | 16110-0080-45 |
| Expiration dates | 2022-12 |
Product
Xolegel (ketoconazole) gel 2%, 45 gram tubes, Rx only, Manufactured by: DPT Laboratories, San Antonio, TX 78215, NDC 16110-080-45
Reason for recall
Failed Viscosity specification: Slightly higher OOS results obtained for viscosity
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1549-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.