Class II · Moderate risk
Testosterone 87.5mg
Presence of Foreign substance - potential presence of metal particulate matter
Triamcinolone Acetonide Cream USP
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
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.
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
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 NDC
45802-0063-05
Compare with the code on your package — it is the most precise check available.
Drug: Triamcinolone
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Triamcinolone Acetonide NDC 45802-0063 |
.25 mg/g | Cream Topical |
Padagis Israel Pharmaceuticals Ltd | Rx |
- Recalling firm
- Padagis US LLC
- Origin
- MN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0048-2025 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Triamcinolone recalls
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Class II · Moderate risk
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Class II · Moderate risk
Testosterone 100mg
Presence of Foreign substance - potential presence of metal particulate matter
Class II · Moderate risk
Tri-Moxi+¿
Presence of particulate matter - Glass like particles.
Class II · Moderate risk
Testosterone / Triamcinolone Acetonide Pellet
CGMP Deviations: Potential presence of metal particulate matter
Other recalls by Padagis US LLC
All 2024 recalls
Class II · Moderate risk
Nystatin Cream USP
Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
Class II · Moderate risk
Estradiol Gel
Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product.
Class II · Moderate risk
Trospium Chloride Extended-Release Capsules
Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules
Class II · Moderate risk
Gynazole-1
Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process.
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