Agency classClass IIOur severity:High FDA (Drugs)·D-0543-2017·Announced 2017-03-22

Synergy Rx Recalls Salicylic Acid and 5-FU Products for Sterility Concerns

Synergy Rx is recalling salicylic acid and 5-FU prescription products due to lack of assurance of sterility and 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 involves a risk-of-harm product (sterility failure) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Synergy Rx is recalling Salicylic Acid Solution in all strengths (including 20%, 25%, 30%, and 40%), Salicylic Acid 20%/5-FU 2.5% Cream, and Salicylic Acid 20%/5-FU 2.5% Medication Stick. These are prescription-only products distributed nationwide within the United States. The recall covers all lots of these products.

The recall was initiated due to a lack of assurance of sterility and Current Good Manufacturing Practice (CGMP) deviations. The source text does not report any specific illnesses, injuries, or fatalities associated with these products.

Consumers and healthcare providers should stop using these products and contact their healthcare provider or the recalling firm, Synergy Rx, for further instructions.

The recalled product

Product: SALICYLIC ACID SOLUTION in all strengths including 20%, 25%, 30%, and 40%, SALICYCLIC ACID 20%. 2.5%5-FU, SALICYCLIC ACID 20%, 5-FU 2.5% CREAM, SALICYCLIC ACID 20%/5-FU 2.5% MEDICATION STICK, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Manufacturer: Synergy Rx
Category: Drug — Topical Prescription Medication
Hazard: sterility-failure
cgmp-deviation

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 →

Same manufacturer · Synergy Rx

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Same hazard · sterility failure