CLASS III Drug recall · Reported 19 Mar 2014 · FDA Enforcement Report
Triamcinolone Acetonide Cream recalled by Fougera Pharmaceuticals
Fougera Pharmaceuticals is recalling Triamcinolone Acetonide Cream USP, 0.1%, distributed nationwide in the US. The recall was initiated on 29 Jan 2014 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-1152-2014
- FDA event ID
- 67329
- Recalling firm
- Fougera Pharmaceuticals, Melville, NY
- Manufacturer
- E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 29 Jan 2014
- FDA classified
- 7 Mar 2014
- Reported
- 19 Mar 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Creams, Ointments & Gels
Timeline
| 29 Jan 2014 | Recall initiated by company | |
| 7 Mar 2014 | Classified by FDA | +37 days |
| 19 Mar 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Label Error on Declared Strength: There is a misprint on the end flap which read 01% rather than 0.1%.
Product as listed by the FDA
Triamcinolone Acetonide Cream USP, 0.1%, Net Wt 80 grams per tube, Rx only, E. Fougera & Co., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0004-80, UPC 3 0168-0004-80 8.
Where it was distributed
Nationwide.
Questions about this recall
Why was it recalled?
Labeling: Label Error on Declared Strength: There is a misprint on the end flap which read 01% rather than 0.1%.
Which lots are affected?
Lot #: 485P, 486P, 487P, 488P, Exp 06/15; 638P, 639P, 640P, Exp 07/15; 753P, 754P, 755P, Exp 08/15; 898P, 756P, 757P, 758P, 899P, 900P, 901P, 902P, Exp 09/15
Where was it sold?
Nationwide.
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 Fougera Pharmaceuticals
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Desonide Ointment recalled by Fougera Pharmaceuticals | Fougera Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS II | Fluocinonide Gel recalled by Fougera Pharmaceuticals | Fougera Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Triamcinolone Acetonide Lotion recalled by Fougera Pharmaceuticals | Fougera Pharmaceuticals | Other | Nationwide |
| Drug | CLASS III | Triamcinolone Acetonide Lotion recalled by Fougera Pharmaceuticals | Fougera Pharmaceuticals | Other | Nationwide |
| Drug | CLASS III | Ketoconazole Cream, 2% tube recalled by Fougera PharmaceuticalsKetoconazole | Fougera Pharmaceuticals | Potency & Assay | 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 |