Synergy Rx Recalls Gentle Bleaching Cream Due to Sterility Concerns
Synergy Rx is recalling Gentle Bleaching Cream because the product lacks assurance of sterility and has 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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, which corresponds to a Severe severity score under the rubric for significant injury or property damage reports or high-risk conditions.
Plain-English summary
Synergy Rx is recalling Gentle Bleaching Cream (Retinoic Acid 0.025, Kojic Acid 3%, Hydrocortisone 1%), a prescription-only product. The recall was initiated due to a lack of assurance of sterility and Current Good Manufacturing Practice (CGMP) deviations.
The product was distributed nationwide within the United States. All lots are affected by this recall.
Consumers with this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- GENTLE BLEACHING CREAM (Retinoic Acid 0.025, Kojic Acid 3%,Hydrocortisone 1%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
- Manufacturer
- Synergy Rx
- 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 →- SevereK.C. Pharmaceuticals Recalls Target Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tri-MIX Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Semaglutide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tirzepatide Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Leader Advanced Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
Similar recalls
- SevereSpecialty Compounding Recalls All Prescription Products Due to Sterility Concerns
FDA (Drugs) · 2014-11-05
- SevereGentle Eyes Lubricant Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- Severe
- SevereRed Mountain Compounding Recalls S-TRIMIX Injection Due to Sterility Concerns
FDA (Drugs) · 2019-11-13
- SevereRXQ Compounding Recalls Diazepam Injection Due to Sterility Concerns
FDA (Drugs) · 2019-08-14
- SevereRXQ Compounding Recalls Phenylephrine Syringes Due to Sterility Concerns
FDA (Drugs) · 2019-08-14