Fougera Recalls Fluocinonide Gel Due to Residual Solvent Concerns
Fougera Pharmaceuticals is recalling specific lots of Fluocinonide Gel USP, 0.05% because they may not meet USP requirements for residual solvents.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The hazard involves potential residual solvents, which is a quality control issue rather than a high-risk pathogen or structural defect.
Plain-English summary
Fougera Pharmaceuticals Inc. is recalling specific lots of Fluocinonide Gel USP, 0.05%, a prescription-only topical medication. The affected products are available in 15-gram and 60-gram tubes and were distributed nationwide and in Puerto Rico.
The recall was initiated because the recalled lots may not meet the requirements for residual solvents as outlined in USP <467>. The specific lot numbers and expiration dates are listed in the structured product information.
Consumers with this product should stop using it and contact their healthcare provider or pharmacist for guidance on returning the product or obtaining a replacement.
The recalled product
- Product
- FLUOCINONIDE GEL USP, 0.05%, Rx only, For External Use Only, Not For Ophthalmic Use, a) NET WT 15 gram tubes and b) NET WT 60 grams tubes, E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0135-15 (15 g) and NDC 0168-0135-60 (60 g)
- Manufacturer
- Fougera Pharmaceuticals Inc.
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- a) 15 gram lot numbers: 549N
- 550N
- 551N Exp. 1/2015
- EB1961
- Exp. 2/2017
- b) 60 gram lot numbers: 546N
- 547N
- 548N
- Exp. 1/2015
- EB0144
Distribution
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