Class III โ€” Low Risk

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

Major Oral Peroxide (Carbamide Peroxide 10%) Recalled by Axcentria Pharmaceuticals LLC Due to Stability data does not support expiration date: Stability...

Date: August 17, 2012
Company: Axcentria Pharmaceuticals LLC
Status: Terminated
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 Axcentria Pharmaceuticals LLC directly.

Affected Products

Major Oral Peroxide (Carbamide Peroxide 10%), 2 fl oz (60 mL), Distributed by: Major Pharmaceuticals 31778 Enterprise Drive, Livonia, MI 48150, NDC 0904-4062-03

Quantity: 17,679 bottles

Why Was This Recalled?

Stability data does not support expiration date: Stability data indicates the Carbamide Peroxide will degrade below acceptable levels within the 24-month expiration date printed on the packaging.

Where Was This Sold?

This product was distributed to 1 state: MI

Affected (1 state)Not affected

About Axcentria Pharmaceuticals LLC

Axcentria Pharmaceuticals LLC has 2 total recalls tracked by RecallDetector.

Related Recalls

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