FDA Drug recall D-1549-2022
Xolegel (ketoconazole) gel 2%, 45 gram tubes, Rx only, Manufactured by: DPT Laboratories, San Antonio, TX 78215, NDC 16110-080-45
- FDA Drug
- Class III
- terminated
- Published 2022-10-05
On 2022-10-05 the FDA classified a Class III recall of Xolegel (ketoconazole) gel 2%, 45 gram tubes, Rx only, Manufactured by: DPT Laboratories, San Antonio, TX 78215, NDC 16110-080-45 by Almirall, citing failed Viscosity specification: Slightly higher OOS results obtained for viscosity.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1549-2022 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2022-09-16 |
| Published | 2022-10-05 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Almirall |
| Distribution | US |
Product
Xolegel (ketoconazole) gel 2%, 45 gram tubes, Rx only, Manufactured by: DPT Laboratories, San Antonio, TX 78215, NDC 16110-080-45
Reason
Failed Viscosity specification: Slightly higher OOS results obtained for viscosity
Identifiers
| code_info | Lot #: RGAF, Exp. Date 12/2022 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1549-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.