Fougera Pharmaceuticals recalls

Fougera Pharmaceuticals has 8 recalls on record with the FDA and USDA, the earliest in 2012 and the latest reported on 29 Mar 2017. The most frequent reason is potency & assay.

Total recalls8since 2012

Last 12 months0reported

Class I00% of total

Ongoing0latest 29 Mar 2017

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 2 25%Class III 6 75%

Why fougera pharmaceuticals is recalled

Product types

Creams, Ointments & Gels563%
Eye Drops338%

Brands

Ketoconazole225%
Triamcinolone Acetonide113%

By year

2017113%
2014563%
2013113%
2012113%

All fougera pharmaceuticals recalls, newest first

8 total

Reported	Class	Recall	Company	Reason	Where
29 Mar 2017Drug	CLASS II	Desonide Ointment recalled by Fougera Pharmaceuticals	Fougera Pharmaceuticals	Packaging Defects	Nationwide
19 Nov 2014Drug	CLASS II	Fluocinonide Gel recalled by Fougera Pharmaceuticals	Fougera Pharmaceuticals	Potency & Assay	Nationwide
23 Jul 2014Drug	CLASS III	Triamcinolone Acetonide Lotion recalled by Fougera Pharmaceuticals	Fougera Pharmaceuticals	Other	Nationwide
23 Jul 2014Drug	CLASS III	Triamcinolone Acetonide Lotion recalled by Fougera Pharmaceuticals	Fougera Pharmaceuticals	Other	Nationwide
19 Mar 2014Drug	CLASS III	Triamcinolone Acetonide Cream recalled by Fougera PharmaceuticalsTriamcinolone Acetonide	Fougera Pharmaceuticals	Other	Nationwide
5 Feb 2014Drug	CLASS III	Ketoconazole Cream, 2% tube recalled by Fougera PharmaceuticalsKetoconazole	Fougera Pharmaceuticals	Potency & Assay	Nationwide
10 Apr 2013Drug	CLASS III	Fougera Ketoconazole Cream 2% tube recalled by Fougera PharmaceuticalsKetoconazole	Fougera Pharmaceuticals	Potency & Assay	Nationwide
1 Aug 2012Drug	CLASS III	Erythromycin Topical Solution USP, 2% bottle with applicator recalled	Fougera Pharmaceuticals	Foreign Material	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.