CLASS III Drug recall · Reported 10 Apr 2013 · FDA Enforcement Report
Fougera Ketoconazole Cream 2% tube recalled by Fougera Pharmaceuticals
Fougera Pharmaceuticals is recalling Fougera Ketoconazole Cream 2% tube, distributed nationwide in the US. The recall was initiated on 18 Jul 2012 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-241-2013
- FDA event ID
- 62625
- 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 Jul 2012
- FDA classified
- 2 Apr 2013
- Reported
- 10 Apr 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Creams, Ointments & Gels
Timeline
| 18 Jul 2012 | Recall initiated by company | |
| 2 Apr 2013 | Classified by FDA | +258 days |
| 10 Apr 2013 | Published in enforcement report | +8 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: Ketoconazole Cream 2% is the subject of a voluntary drug recall by Fougera due to an Out Of Specification result for an unknown degradant product
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
Fougera Ketoconazole Cream 2%, 15g tube, Rx only, Labeled with E. Fougera & Co., a division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0099-15
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications: Ketoconazole Cream 2% is the subject of a voluntary drug recall by Fougera due to an Out Of Specification result for an unknown degradant product
Which lots are affected?
Lot #: 835H, Exp 07/12
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 | 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 | Ketoconazole Cream, 2% tube recalled by Fougera PharmaceuticalsKetoconazole | Fougera Pharmaceuticals | Potency & Assay | Nationwide |