Synergy Rx Recalls Retinoic Acid Solution Due to Sterility Concerns
Synergy Rx is recalling all lots of Retinoic Acid Solution due to a lack of assurance of sterility and CGMP deviations.
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, but the source text does not report any illnesses, injuries, or hospitalizations, and the hazard is a manufacturing deviation rather than a confirmed high-risk pathogen or structural defect.
Plain-English summary
Synergy Rx is recalling all lots of Retinoic Acid Solution in all strengths, including 0.3%, 0.4%, 0.5%, and 1%. The product is a prescription-only liquid solution distributed nationwide within the United States.
The recall was initiated due to a lack of assurance of sterility and Current Good Manufacturing Practice (CGMP) deviations. The source text does not specify the number of affected units or report any illnesses or injuries.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- RETINOIC ACID SOLUTION in all strengths including 0.3%, 0.4%, 0.5%, 1%, RETINOIC ACID SOLUTION LIQUID, 0.4%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
- Manufacturer
- Synergy Rx
- Category
- Drug — Topical Solution
- 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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