CLASS III Drug recall · Reported 5 Feb 2014 · FDA Enforcement Report
Ketoconazole Cream, 2% tube recalled by Fougera Pharmaceuticals
Fougera Pharmaceuticals is recalling Ketoconazole Cream, 2% tube, distributed nationwide in the US. The recall was initiated on 18 Nov 2013 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-1044-2014
- FDA event ID
- 66881
- Recalling firm
- Fougera Pharmaceuticals, Melville, NY
- Brand
- Ketoconazole
- Manufacturer
- E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 18 Nov 2013
- FDA classified
- 30 Jan 2014
- Reported
- 5 Feb 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Creams, Ointments & Gels
Timeline
| 18 Nov 2013 | Recall initiated by company | |
| 30 Jan 2014 | Classified by FDA | +73 days |
| 5 Feb 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications: Out-of-Specification degradant results.
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
KETOCONAZOLE CREAM, 2%, 30 gram tube, Rx only, E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0099-30, UPC 3 0168-0099-30 9.
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications: Out-of-Specification degradant results.
Which lots are affected?
Lot #: 495P, Exp 07/14
Where was it sold?
Nationwide and Puerto Rico
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 | Triamcinolone Acetonide Cream recalled by Fougera PharmaceuticalsTriamcinolone Acetonide | Fougera Pharmaceuticals | Other | Nationwide |
Other Ketoconazole recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ketoconazole Cream recalled by Mckesson Medical-SurgicalKetoconazole | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Ketoconazole 2%/hydrocortisone 1.5% Cream recalled by Synergy Rx | Synergy Rx | Sterility | Nationwide |
| Drug | CLASS III | Fougera Ketoconazole Cream 2% tube recalled by Fougera PharmaceuticalsKetoconazole | Fougera Pharmaceuticals | Potency & Assay | Nationwide |