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.
Product description
Triamcinolone Acetonide Cream USP, 0.025%, 1 LB (454 g) per jar, Rx Only, Manufactured By Padagis, Minneapolis, MN 55427. NDC: 45802-0063-05
Lot numbers, UPCs & expiration codes
Lot #: 2024154238, 2024174344, Exp. Date 3/31/2026
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0048-2025
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 11, 2024
- FDA report date
- Nov 27, 2024
- Quantity
- 10,872 jars
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Padagis US LLC
Original FDA data
Every field from FDA enforcement report D-0048-2025, exactly as published.
Show all FDA fields
- City
- Minneapolis
- State
- MN
- Status
- Terminated
- Country
- United States
- Event ID
- 95736
- Address
- 3940 Quebec Ave N
- Code information
- Lot #: 2024154238, 2024174344, Exp. Date 3/31/2026
- Postal code
- 55427-1244
- Report date
- Nov 27, 2024
- Product type
- Drugs
- Recall number
- D-0048-2025
- Classification
- Class III
- Recalling firm
- Padagis US LLC
- Product quantity
- 10,872 jars
- Termination date
- Sep 29, 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Triamcinolone Acetonide Cream USP, 0.025%, 1 LB (454 g) per jar, Rx Only, Manufactured By Padagis, Minneapolis, MN 55427. NDC: 45802-0063-05
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Oct 11, 2024
- Initial firm notification
- Letter
- Center classification date
- Nov 18, 2024