Synergy Rx Recalls Tri-Bleaching Cream Due to Sterility Assurance Concerns
Synergy Rx is recalling Tri-Bleaching Cream because the product lacks assurance of sterility and has CGMP deviations.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in a prescription drug, which meets the criteria for a Severe rating.
Plain-English summary
Synergy Rx is recalling Tri-Bleaching Cream (Retinoic Acid 0.05%, Hydroquinone 8%, Fluocinolone 0.01%), a prescription-only product, due to a lack of assurance of sterility. The recall also cites Current Good Manufacturing Practice (CGMP) deviations.
The recall covers all lots of the product. Distribution was nationwide within the United States.
Consumers should stop using the product and contact their healthcare provider or the recalling firm for instructions on return or disposal.
The recalled product
- Product
- TRI-BLEACHING CREAM (Retinoic Acid 0.05%, Hydroquinone 8%, Fluocinolone 0.01%), 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.
See all 81 products in this recall →Related recalls
Same manufacturer · Synergy Rx
See all →- SevereSynergy Rx Recalls Lidocaine Creams Due to Sterility Assurance Issues
FDA (Drugs) · 2017-03-22
- HighSynergy Rx Recalls Ultra Lite Cream Due to Sterility Concerns
FDA (Drugs) · 2017-03-22
- SevereSynergy Rx Recalls Lactic Acid Solution Due to Sterility Concerns
FDA (Drugs) · 2017-03-22
- HighSynergy Rx Modified Jessner Peel Recalled for Sterility Assurance Issues
FDA (Drugs) · 2017-03-22
- SevereSynergy Rx Recalls CLEAR 2 Due to Sterility Assurance Concerns
FDA (Drugs) · 2017-03-22
Same hazard · sterility
See all →- SevereRegeneron Recalls Libtayo Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-08-26
- SeverePrestige Recalls Clear Eyes Maximum Itchy Eye Relief Due to Sterility Concerns
FDA (Drugs) · 2026-08-19
- SevereROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29
- HighROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29
- SevereFDA Recalls ROHTO OPTIC GLOW Eye Drops Over Sterility Concerns
FDA (Drugs) · 2026-07-29