Rising Pharma recalls 5mg Temozolomide capsules with impurities detected in stability testing. Patients should contact their doctor for alternative treatment options.
Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
Rising Pharma is recalling 5mg Temozolomide capsules that failed stability testing, potentially containing harmful impurities. This could cause serious health risks if used without proper medical supervision.
The capsules failed stability testing, indicating possible impurities that could harm patients. This risk is specific to the medication's intended use in cancer treatment, where precise dosing is critical.
Patients prescribed Temozolomide capsules by a doctor are affected. Those with cancer treatments using this medication are at highest risk.
Check for the product label: Temozolom: 5mg capsules in 5-capsule bottles, Rx only. The lot number 1TM0524003A with expiration date 09/2026 is associated with this recall.
Your doctor will advise on alternative treatment options and whether the capsules are safe to use.
The recall indicates potential impurities detected during stability testing, so it is not safe to use without medical supervision.
Contact your doctor for alternative treatment options and follow their instructions.
Check for the product label: Temozolomide 5mg capsules in 5-capsule bottles, Rx only, with lot number 1TM0524003A and expiration date 09/2026.
We’ve drafted a message you can send Rising Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0384-2026 — Rising Pharma Rising Pharma Hello, I own a Rising Pharma that is covered by recall D-0384-2026 from Rising Pharma. 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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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.
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