Amerigen Pharmaceuticals Inc. recalls Temozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 43975-252-05) b) 14-count bottle (NDC 43975-252-14), Rx
Amerigen Pharmaceuticals recalls 5mg Temozolomide capsules (5-count and 14-count bottles) due to failed dissolution specifications. This is a prescription-only medication.
Lower-risk recall
Failed dissolution specifications
Contact the company & request your remedy
What happened, in plain English
Amerigen Pharmaceuticals is recalling 5mg Temozolomide capsules in 5-count and 14-count bottles because they failed dissolution specifications. This means the medication may not work as intended for cancer treatment. Read more at govinfonow.com/recall/39186-amerigen-temozolomide-capsules-5mg-recall-failed-dissolution-specifications.
Source Summary by GovInfoNow · govinfonow.com/recall/39186-amerigen-temozolomide-capsules-5mg-recall-failed-dissolution-specifications · Updated October 5, 2026 · FDA enforcement record: FDA #D-0516-2019
Cite this page
“Amerigen Temozolomide Capsules 5mg Recall: Failed Dissolution Specifications.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39186-amerigen-temozolomide-capsules-5mg-recall-failed-dissolution-specifications. Based on FDA recall #D-0516-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0516-2019%22&limit=1).
Why it’s dangerous
The capsules failed to dissolve properly as required by the manufacturer's specifications. This could affect the medication's effectiveness in treating cancer.
Who’s affected
Prescription patients using Temozolomide for cancer treatment. Those with the specific NDC numbers listed are most at risk.
How to tell if you have this one
Check for 5-count or 14-count bottles labeled 'Temozolomide Capsules, 5 mg' with NDC numbers 43975-252-05 or 43975-252-14. These are prescription-only medications.
- Brand
Amerigen Pharmaceuticals- Category
Drug
What to do — step by step
Check Product Details
Look for the NDC numbers 43975-252-05 or 43975-252-14 on the bottle label.
Questions people ask
Is this medication safe to use?
The recall is due to failed dissolution specifications, which may affect the medication's effectiveness. Patients should contact their healthcare provider for guidance.
What should I do if I have this medication?
The recall does not specify a remedy, so contact your healthcare provider for advice on whether to continue using the medication.
Are there any safety risks?
The hazard is related to the medication not dissolving properly, which could affect treatment effectiveness but does not pose an immediate safety risk.
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-0516-2019 — Amerigen Pharmaceuticals Amerigen Pharmaceuticals Hello, I own a Amerigen Pharmaceuticals that is covered by recall D-0516-2019 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-0516-2019 (February 19, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0516-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 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.