Synergy Rx Recalls Tretinoin Cream Due to Sterility Assurance Issues
Synergy Rx is recalling Tretinoin 0.02% in Oil Free Cream because of 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 explicitly states no illnesses or injuries are reported and the hazard is theoretical (lack of assurance of sterility), which aligns with the Moderate severity criteria for voluntary precautionary recalls or low-risk contamination without reported harm.
Plain-English summary
Synergy Rx is recalling Tretinoin 0.02% in Oil Free Cream, a prescription-only medication. The recall is being conducted because of a lack of assurance of sterility and Current Good Manufacturing Practice (CGMP) deviations.
The affected product is distributed nationwide within the United States. The recall includes all lots of the product. The source text does not specify the number of units affected or the specific dates of distribution.
Consumers should stop using the product and contact their healthcare provider or the recalling firm for further instructions. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- TRETINOIN 0.02% IN OIL FREE CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
- Manufacturer
- Synergy Rx
- Category
- Drug — Topical Prescription
- 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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