The Recall Desk
ModerateFDA (Drugs)·D-0539-2017·Announced 2017-03-22

Synergy Rx Recalls Glycolic Acid Products Due to Sterility Concerns

Synergy Rx is recalling specific glycolic acid prescription products due to 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 and involves CGMP deviations regarding sterility assurance without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Synergy Rx is recalling Glycolic Acid 15% Lotion, Glycolic Acid 20% Gel, Glycolic Acid 6% Lotion, and Glycolic Acid 5% Cream. The recall is being conducted because of a lack of assurance of sterility and Current Good Manufacturing Practice (CGMP) deviations.

The affected products are prescription-only (Rx only) and were distributed nationwide within the United States. All lots of these specific products are included in the recall.

Consumers with these products should stop using them and contact their healthcare provider or pharmacist for further instructions.

The recalled product

Product
GLYCOLIC ACID 15% LOTION, GLYCOLIC ACID 20% GEL, GLYCOLIC ACID 6% LOTION, GLYCOLIC ACID 5% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Manufacturer
Synergy Rx

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 →