Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Remeven Cream Recalled by Stratus Pharmaceuticals Inc Due to Crystallization; Complaints that cream appears to have crystallized

Date: May 26, 2016
Company: Stratus Pharmaceuticals Inc
Status: Completed
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Stratus Pharmaceuticals Inc directly.

Affected Products

Remeven Cream, (50% Urea in a Cream Base), a) 5.0 oz (142 g) and b) 9.0 oz (255 g) tubes, Rx only, Manufactured by Sonar Products Inc, Carlstadt, NJ. Distributed by Stratus Pharmaceuticals Inc., Miami, FL.

Quantity: a) 12,345 tubes; b) 8,578 tubes

Why Was This Recalled?

Crystallization; Complaints that cream appears to have crystallized

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Stratus Pharmaceuticals Inc

Stratus Pharmaceuticals Inc has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report