Medications & Supplements/Topical Products

Triamcinolone Acetonide Cream Recalled for Potency Issues

Agency Publication Date: November 18, 2024

Summary

Padagis US LLC is recalling 10,872 jars of Triamcinolone Acetonide Cream USP, 0.025% (triamcinolone acetonide). Long-term stability testing revealed that the medication was not meeting potency specifications, resulting in jars that could be either subpotent (too weak) or superpotent (too strong). The recall affects prescription 1 lb (454 g) jars sold under NDC 45802-0063-05.

Risk

A subpotent drug may not effectively treat the underlying skin condition, while a superpotent drug can increase the risk of side effects from the corticosteroid. No incidents or injuries have been reported to date.

What You Should Do

This recall affects 1 lb (454 g) jars of Padagis Triamcinolone Acetonide Cream USP, 0.025% (NDC 45802-0063-05).
Check the label of your medication jar for lot numbers 2024154238 or 2024174344, both of which have an expiration date of 3/31/2026.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Padagis US LLC directly for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Triamcinolone Acetonide Cream USP, 0.025% (1 lb / 454 g jar)

Variants: 0.025%, 1 LB (454 g), Cream

Lot Numbers:

2024154238 (Exp. 3/31/2026)

2024174344 (Exp. 3/31/2026)

NDC:

45802-0063-05

Rx Only. Manufactured By Padagis, Minneapolis, MN 55427.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95736

Status: Resolved

Manufacturer: Padagis US LLC

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 10,872 jars

Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects 1 lb (454 g) jars of Padagis Triamcinolone Acetonide Cream USP, 0.025% (NDC 45802-0063-05).

Check the label of your medication jar for lot numbers 2024154238 or 2024174344, both of which have an expiration date of 3/31/2026.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Padagis US LLC directly for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.