Class III — Low Risk

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

Temozolomide Capsules Recalled by Amerigen Pharmaceuticals Inc. Due to Failed dissolution specifications

Date: February 19, 2019
Company: Amerigen Pharmaceuticals Inc.
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 Amerigen Pharmaceuticals Inc. directly.

Affected Products

Temozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 43975-252-05) b) 14-count bottle (NDC 43975-252-14), Rx only, Mfd. by: Stason Pharmaceuticals, Inc., Irvine, CA 92618, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ 07071

Quantity: a) 2,413 bottles b) 3,355 bottles

Why Was This Recalled?

Failed dissolution specifications

Where Was This Sold?

Product was distributed to 4 wholesalers/distributors and 1 retail account who may have further distribute the product throughout the United States.

About Amerigen Pharmaceuticals Inc.

Amerigen Pharmaceuticals Inc. has 4 total recalls tracked by RecallDetector.

Related Recalls

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