The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0595-2017·Announced 2017-03-22

Synergy Rx Recalls Metronidazole and Azelaic Acid Products for Sterility Concerns

Synergy Rx is recalling Metronidazole 1% Gel and Metronidazole/Niacinamide/Azelaic Cream 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 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, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Synergy Rx is voluntarily recalling Metronidazole 1% Gel and Metronidazole 1%/Niacinamide 4%/Azelaic Cream 10% 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 medications distributed nationwide within the United States. The recall covers all lots of these specific products.

Consumers and healthcare providers should stop using the recalled products and contact their healthcare provider or pharmacist for further instructions. Synergy Rx can be reached at (855) 792-6676 for additional information.

The recalled product

Product
METRONIDAZOLE 1% GEL, METRONIDAZOLE 1%/ NIACINAMIDE 4%/ AZELAIC CREAM 10% 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

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 →

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