Triamcinolone Acetonide Cream USP Recalled for Out-of-Specification Potency Variance
Padagis is recalling 10,872 jars of Triamcinolone Acetonide Cream USP 0.025% nationwide because some jars contain subpotent or superpotent active ingredient levels. The defect was discovered during long-term stability testing.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III recall with no reported illnesses or injuries. The potency variance was discovered during manufacturing testing, not in the field. FDA Class III recalls typically score 1-2; this rates 2 (Moderate) because it involves a pharmaceutical with actual potency defects.
Plain-English summary
Padagis US LLC is recalling 10,872 jars of Triamcinolone Acetonide Cream USP, 0.025%, a prescription corticosteroid cream distributed nationwide. The product was manufactured in Minneapolis, Minnesota. The recalled lots are 2024154238 and 2024174344, with an expiration date of March 31, 2026.
The FDA initiated the recall because out-of-specification assay results were identified during Uniformity of Container testing performed as part of long-term stability testing. Testing revealed that some jars contain less active ingredient than specified (subpotent), while others contain more than specified (superpotent).
Patients currently using the affected product should consult their healthcare provider or pharmacist. Healthcare professionals should verify inventory against the recalled lot numbers and discontinue use of affected stock.
The recalled product
- 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
- Manufacturer
- Padagis US LLC
- Category
- Drug — Topical Corticosteroid
- Hazard
- subpotency
- superpotency
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot #: 2024154238
- 2024174344
- Exp. Date 3/31/2026
Distribution
Distributed nationwide across the United States.
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