Synergy Rx Fluocinonide Solution Recalled for Sterility Assurance Issues
Synergy Rx is recalling Fluocinonide 0.05% Solution due to a lack of assurance of sterility and CGMP deviations.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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. The source text does not report any illnesses, injuries, or hospitalizations, and the hazard is described as a lack of assurance of sterility rather than a confirmed contamination event, fitting the criteria for a moderate severity score.
Plain-English summary
Synergy Rx is recalling Fluocinonide 0.05% Solution, a prescription-only medication. The recall was initiated because the product lacks assurance of sterility and is associated with Current Good Manufacturing Practice (CGMP) deviations.
The affected product is distributed nationwide within the United States. The recall includes all lots of the medication. The source text does not specify the number of units recalled or the specific dates of distribution.
Consumers with this product should stop using it and contact their healthcare provider or pharmacist for guidance on disposal or replacement. The recall is classified as FDA Class II, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- FLUOCINONIDE 0.05% SOLUTION, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
- Manufacturer
- Synergy Rx
- Category
- Drug — Topical Steroid
- 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 (1)
- All Lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 81 recalled by Synergy Rx under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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