CLASS II Drug recall · Reported 7 Sep 2022 · FDA Enforcement Report
Triamcinolone Acetonide Cream USP, 0.1% tube recalled by Padagis US
Padagis US is recalling Triamcinolone Acetonide Cream USP, 0.1% tube, distributed nationwide in the US. The recall was initiated on 17 Aug 2022 and the FDA has classified it as Class II.
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-1497-2022
- FDA event ID
- 90790
- Recalling firm
- Padagis US, Minneapolis, MN
- Manufacturer
- Padagis Israel Pharmaceuticals Ltd
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Aug 2022
- FDA classified
- 7 Sep 2022
- Reported
- 7 Sep 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Creams, Ointments & Gels
Timeline
| 17 Aug 2022 | Recall initiated by company | |
| 7 Sep 2022 | Classified by FDA | +21 days |
| 7 Sep 2022 | Published in enforcement report | +0 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
Product as listed by the FDA
Triamcinolone Acetonide Cream USP, 0.1%, 80 g tube, Rx Only, Manufactured By Perrigo, Bronx, NY 10457, Distributed By Perrigo, Allegan, MI 49010, NDC 45802-064-36.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
Which lots are affected?
Lot 2CT0486 , Exp 02/29/2024
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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
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|---|---|---|---|---|---|
| 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 III | Triamcinolone Acetonide Cream recalled by Padagis US | Padagis US | Potency & Assay | 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 |
Other Triamcinolone Acetonide recalls
All 26| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Triamcinolone Acetonide Cream recalled by Padagis US | Padagis US | Potency & Assay | Nationwide |
| 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 |