Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0589-2017·Announced 2017-03-22

Synergy Rx Recalls Tretinoin Cream Due to Sterility Assurance Issues

Synergy Rx is recalling Tretinoin 0.02% in Oil Free Cream because of a 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 2/5 (Moderate).

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, but the source text explicitly states no illnesses or injuries are reported and the hazard is theoretical (lack of assurance of sterility), which aligns with the Moderate severity criteria for voluntary precautionary recalls or low-risk contamination without reported harm.

Plain-English summary

Synergy Rx is recalling Tretinoin 0.02% in Oil Free Cream, a prescription-only medication. The recall is being conducted because of 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 includes all lots of the product. The source text does not specify the number of units affected or the specific dates of distribution.

Consumers should stop using the product and contact their healthcare provider or the recalling firm for further instructions. The source text does not report any illnesses or injuries associated with this recall.

The recalled product

Product: TRETINOIN 0.02% IN OIL FREE CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
Manufacturer: Synergy Rx
Category: Drug — Topical Prescription
Hazard: sterility
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

See all →

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Severe
Synergy Rx Recalls Lactic Acid Solution Due to Sterility Concerns
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High
Synergy Rx Modified Jessner Peel Recalled for Sterility Assurance Issues
FDA (Drugs) · 2017-03-22
Severe
Synergy Rx Recalls CLEAR 2 Due to Sterility Assurance Concerns
FDA (Drugs) · 2017-03-22

Same hazard · sterility