CLASS III Drug recall · Reported 27 Nov 2024 · FDA Enforcement Report
Triamcinolone Acetonide Cream recalled by Padagis US
Padagis US is recalling Triamcinolone Acetonide Cream USP, 0.025% per, distributed nationwide in the US. The recall was initiated on 11 Oct 2024 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0048-2025
- FDA event ID
- 95736
- Recalling firm
- Padagis US, Minneapolis, MN
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 11 Oct 2024
- FDA classified
- 18 Nov 2024
- Reported
- 27 Nov 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Creams, Ointments & Gels
Timeline
| 11 Oct 2024 | Recall initiated by company | |
| 18 Nov 2024 | Classified by FDA | +38 days |
| 27 Nov 2024 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Triamcinolone Acetonide Cream USP, 0.025%, 1 LB (454 g) per jar, Rx Only, Manufactured By Padagis, Minneapolis, MN 55427. NDC: 45802-0063-05
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Subpotent and Superpotent Drug. Out of specification assay results recorded as part of Uniformity of Container test during long-term stability testing.
Which lots are affected?
Lot #: 2024154238, 2024174344, Exp. Date 3/31/2026
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Padagis US
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Nystatin Cream USP, (100,000 USP Nystatin Units) recalled by Padagis USNystatin | Padagis US | Potency & Assay | Nationwide |
| Drug | CLASS II | Estradiol Gel, 0.1%, 0.25 mg/g, 30 packets recalled by Padagis US | Padagis US | Packaging Defects | Nationwide |
| Drug | CLASS II | Trospium Chloride Extended-Release Capsules, 60 mg recalledTrospium Chloride | Padagis US | Other | Nationwide |
| Drug | CLASS II | Gynazole-1, (Butoconazole Nitrate) Vaginal Cream recalled by Padagis USGynazole 1 | Padagis US | Packaging Defects | Nationwide |
| Drug | CLASS III | Evamist (estradiol transdermal spray) recalled by Padagis USEvamist | Padagis US | Potency & Assay | Nationwide |
Other Triamcinolone Acetonide recalls
All 26| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Zilretta (triamcinolone acetonide extended-release recalledZilretta | Pacira Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Drug Vial Label: Zilretta¿ recalled by Pacira PharmaceuticalsZilretta | Pacira Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Triamcinolone Acetonide Injectable Suspension recalled by Eugia USTriamcinolone Acetonide | Eugia US | Particulate Matter | Nationwide |
| Drug | CLASS II | Triamcinolone Acetonide cream, 0.1% tube recalled by Direct RxTriamcinolone Acetonide | Direct Rx | Manufacturing (CGMP) Deviations | GA, ID |
| Drug | CLASS II | Triamcinolone Acetonide Cream USP, 0.1% tube recalled by Padagis USTriamcinolone Acetonide | Padagis US | Manufacturing (CGMP) Deviations | Nationwide |