The Recall Desk
ModerateFDA (Drugs)·D-0592-2017·Announced 2017-03-22

Synergy Rx Recalls RETIN-A 0.05% Cream Due to Sterility Concerns

Synergy Rx is recalling RETIN-A 0.05% Cream because of 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 and sterility assurance issues, which aligns with the criteria for moderate severity involving low-risk contamination or voluntary precautionary measures without reported injuries.

Plain-English summary

Synergy Rx is recalling RETIN-A 0.05% Cream, a prescription-only medication. The recall is being conducted due to a lack of assurance of sterility and Current Good Manufacturing Practice (CGMP) deviations.

The affected product is distributed nationwide within the United States. The recall applies to all lots of the product.

Consumers with this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
RETIN-A 0.05% 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 →