Synergy Rx Recalls Jessner's Peel Due to Sterility Assurance Concerns
Synergy Rx is recalling all lots of Jessner's Peel 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (sterility failure) where injury has not yet been reported, which aligns with the High severity criteria.
Plain-English summary
Synergy Rx is recalling all lots of Jessner's Peel, a prescription-only chemical peel containing salicylic acid, resorcinol, and lactic acid. The recall was initiated because the product lacks assurance of sterility and has Current Good Manufacturing Practice (CGMP) deviations.
The affected product was distributed nationwide within the United States. The source text does not specify the number of units recalled or report any illnesses or injuries associated with the product.
Consumers with this product should stop using it and contact their healthcare provider or the recalling firm for instructions on how to proceed.
The recalled product
- Product
- JESSNERS PEEL (salicylic Acid 14% rescorcinol 14%, Lactic acid 14%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
- Manufacturer
- Synergy Rx
- Category
- Drug — Topical Prescription
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
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