# FDA recall D-1549-2022

> **ALMIRALL, LLC** · Class III · drug recall initiated 2022-09-16.

## 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

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-1549-2022
- **Recalling firm:** ALMIRALL, LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-09-16
- **Report date:** 2022-10-05
- **Termination date:** 2023-07-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Malvern, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1549-2022

## Citation

> AI Analytics. FDA recall D-1549-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-1549-2022. Source: US FDA. Licensed CC0.

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