Recalls / Class III
Class IIID-0048-2025
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
- Affected lot / code info
- Lot #: 2024154238, 2024174344, Exp. Date 3/31/2026
Why it was recalled
Subpotent and Superpotent Drug. Out of specification assay results recorded as part of Uniformity of Container test during long-term stability testing.
Recalling firm
- Firm
- Padagis US LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3940 Quebec Ave N, N/A, Minneapolis, Minnesota 55427-1244
Distribution
- Quantity
- 10,872 jars
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2024-10-11
- FDA classified
- 2024-11-18
- Posted by FDA
- 2024-11-27
- Terminated
- 2025-09-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0048-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.