Amerigen Pharmaceuticals Inc. recalls Temozolomide Capsules, 180 mg, packaged in a 14 count bottles, Rx only, Mfd, by: Stason Pharmaceuticals, Inc., Irvine,
Amerigen Pharmaceuticals recalls 14-count Temozolomide capsules (180mg) due to failed dissolution specifications. Patients should contact their doctor for guidance.
Lower-risk recall
Failed Dissolution Specifications
Contact the company & request your remedy
What happened, in plain English
Amerigen Pharmaceuticals is recalling 14-count Temoz: 180mg capsules because they don't dissolve properly. This could affect medication effectiveness for cancer treatment. Read more at govinfonow.com/recall/39306-amerigen-temozolomide-capsules-180mg-recall-failed-dissolution-specifications.
Source Summary by GovInfoNow · govinfonow.com/recall/39306-amerigen-temozolomide-capsules-180mg-recall-failed-dissolution-specifications · Updated October 5, 2026 · FDA enforcement record: FDA #D-0345-2019
Cite this page
“Amerigen Temozolomide Capsules 180mg Recall: Failed Dissolution Specifications.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39306-amerigen-temozolomide-capsules-180mg-recall-failed-dissolution-specifications. Based on FDA recall #D-0345-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0345-2019%22&limit=1).
Why it’s dangerous
The capsules fail to dissolve correctly, which may lead to improper medication delivery. This could reduce treatment effectiveness for cancer patients.
Who’s affected
Patients prescribed Temozolomide for cancer treatment who received this specific capsule package. Those with cancer treatments using this medication are most at risk.
How to tell if you have this one
Check for 14-count bottles labeled Temozolomide 180mg, manufactured by Stason Pharmaceuticals, Inc., Irvine, CA, with lot number 18E031 and expiration 05/2020.
- Brand
Amerigen Pharmaceuticals- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Terminated- Distribution
Product was distributed to 4 wholesalers and 2 retail accounts who may have further distributed the products.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0344-2019 | Temozolomide Capsules, 20 mg, packaged in a a) 5-count (NDC 43975-253-05) and b) 14 count (NDC 43975-253-14) bottles, Rx only, Mfd, by: Stason Pharmaceuticals, Inc., Irvine, CA, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ; a) Lot # 18B005 A and b) Lot # 18B005 B, exp 02/2020 | 3552 bottles |
| D-0345-2019 | Temozolomide Capsules, 180 mg, packaged in a 14 count bottles, Rx only, Mfd, by: Stason Pharmaceuticals, Inc., Irvine, CA, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ ---- NDC 43975-256-14; Lot # 18E031, exp 05/2020 | 771 bottles |
What to do — step by step
Contact Your Doctor
Talk to your healthcare provider about the recall and possible next steps for your treatment.
Questions people ask
Is this product safe to use?
The recall is due to failed dissolution specifications, which may affect medication effectiveness. Consult your doctor for guidance.
What should I do if I have this product?
Contact your doctor for advice on next steps. Do not stop treatment without medical guidance.
How can I check if I have the recalled product?
Look for 14-count bottles labeled Temozolomide 180mg with lot number 18E031 and expiration 05/2020.
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-0345-2019 — Amerigen Pharmaceuticals Amerigen Pharmaceuticals Hello, I own a Amerigen Pharmaceuticals that is covered by recall D-0345-2019 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-0345-2019 (December 20, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0345-2019 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.