# FDA recall D-0048-2025

> **Padagis US LLC** · Class III · drug recall initiated 2024-10-11.

## Product

Triamcinolone Acetonide Cream USP, 0.025%, 1 LB (454 g) per jar, Rx Only, Manufactured By Padagis, Minneapolis, MN 55427. NDC: 45802-0063-05

## Reason for recall

Subpotent and Superpotent Drug. Out of specification assay results recorded as part of Uniformity of Container test during long-term stability testing.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0048-2025
- **Recalling firm:** Padagis US LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2024-10-11
- **Report date:** 2024-11-27
- **Termination date:** 2025-09-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Minneapolis, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0048-2025

## Citation

> AI Analytics. FDA recall D-0048-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0048-2025. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*