October 2024 FDA Recall Drug by Padagis Us Llc
D-0048-2025 - Subpotent and Superpotent Drug. Out of specification assay results recorded as part of Uniformity of Container test during long-term stability testing.

This Class III drug recall was voluntarily initiated by Padagis Us Llc on October 11, 2024 for the product Drug. The FDA reported the reason for recall as subpotent and superpotent drug. out of specification assay results recorded as part of uniformity of container test during long-term stability testing.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0048-2025

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.
Initiated
10-11-2024
Reported
11-27-2024
Quantity
10,872 jars

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
95736
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Padagis US LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2025
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# : 2024154238, 2024174344, Exp. Date 3/31/2026