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: Out-of-Specification dissolution results obtained during...
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, 20 mg, packaged in a) 5-count bottle(NCD 43975-253-05), b) 14-count bottle (NDC 43975-253-14), Rx only, Mfd. by: Stason Pharmaceuticals, Inc., Irvine, CA 92618, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ 07071.
Quantity: 5,232 bottles: a) 4,146 bottles; b) 1,086 bottles
Why Was This Recalled?
Failed dissolution specifications: Out-of-Specification dissolution results obtained during stability testing.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Amerigen Pharmaceuticals Inc.
Amerigen Pharmaceuticals Inc. has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report