Amerigen Pharmaceuticals Inc. recalls Temozolomide capsules, 20 mg, packaged in a) 5-count bottle(NCD 43975-253-05), b) 14-count bottle (NDC 43975-253-14),
Amerigen Pharmaceuticals recalls 20mg Temozolomide capsules (5-count and 14-count bottles) due to failed dissolution testing. These prescription drugs may not release medication properly.
Lower-risk recall
Failed dissolution specifications: Out-of-Specification dissolution results obtained during stability testing.
Contact the company & request your remedy
What happened, in plain English
Amerigen Pharmaceuticals is recalling 20mg Temozolomide capsules in 5-count and 14-count bottles because they failed dissolution testing. This means the capsules might not release medication properly when taken, which could affect treatment effectiveness. Read more at govinfonow.com/recall/39535-amerigen-temozolomide-capsules-20mg-recall-failed-dissolution-testing.
Source Summary by GovInfoNow · govinfonow.com/recall/39535-amerigen-temozolomide-capsules-20mg-recall-failed-dissolution-testing · Updated October 6, 2026 · FDA enforcement record: FDA #D-0249-2019
Cite this page
“Amerigen Temozolomide Capsules 20mg Recall: Failed Dissolution Testing.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/39535-amerigen-temozolomide-capsules-20mg-recall-failed-dissolution-testing. Based on FDA recall #D-0249-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0249-2019%22&limit=1).
Why it’s dangerous
The capsules failed dissolution testing, meaning they may not release medication properly when taken. This could lead to inconsistent drug levels in the body, potentially reducing treatment effectiveness. However, the recall does not indicate immediate safety risks like injury or death.
Who’s affected
Patients prescribed Temozolomide for cancer treatment who received these specific bottle sizes. Those with the 5-count (lot 17F058A) or 14-count (lot 17F058B) bottles are most at risk.
How to tell if you have this one
Check for 20mg Temozolomide capsules in 5-count bottles labeled NDC 43975-253-05 or 14-count bottles labeled NDC 43975-253-14. These are prescription-only medications manufactured by Stason Pharmaceuticals and distributed by Amerigen.
- Brand
Amerigen Pharmaceuticals- Category
Drug
What to do — step by step
Check Product Details
Look for the bottle size and NDC code on the packaging to confirm if it's affected.
Questions people ask
Why is this product being recalled?
The capsules failed dissolution testing, meaning they may not release medication properly when taken, which could affect treatment effectiveness.
What should I do if I have these capsules?
The recall does not specify a remedy, so contact your healthcare provider for guidance on next steps.
Are there any safety risks from using these capsules?
The recall indicates potential treatment effectiveness issues, but no immediate safety risks like injury or death are mentioned.
Contact Amerigen Pharmaceuticals
We’ve drafted a message you can send Amerigen Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0249-2019 — Amerigen Pharmaceuticals Amerigen Pharmaceuticals Hello, I own a Amerigen Pharmaceuticals that is covered by recall D-0249-2019 from Amerigen Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0249-2019 (October 5, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0249-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 6, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.