The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0534-2017·Announced 2017-03-22

Synergy Rx Recalls Topical Acne Medications Due to Sterility Concerns

Synergy Rx is recalling specific clindamycin and tretinoin products due to 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II, and the source text explicitly cites a 'Lack of Assurance of Sterility' and CGMP deviations, which aligns with the rubric criteria for Severe severity involving significant risk factors.

Plain-English summary

Synergy Rx is recalling several prescription topical acne medications, including Clindamycin 1% / Azelaic Acid 10% Cream, Clindamycin 1.2% / Tretinoin 0.05% Gel, Clindamycin 1.2% / Tretinoin 0.1% Gel, and Clindamycin 2.5% / Benzoyl Peroxide 5%. The recall covers all lots of these products.

The recall was initiated because of a lack of assurance of sterility and Current Good Manufacturing Practice (CGMP) deviations. The products were distributed nationwide within the United States.

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

The recalled product

Product
CLINDAMYCIN 1%, AZELAIC ACID 10% CREAM, CLINDAMYCIN 1.2%/ TRETINOIN 0.05% GEL, CLINDAMYCIN 1.2%/ TRETINOIN 0.1% GEL CLINDAMYCIN 2.5%, BENZOYL PEROXIDE 5%, 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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