Quick Facts at a Glance
- Recall Date
- March 3, 2026
- Hazard Level
- HIGH
- Brands
- Rising Pharmaceuticals, Temozolomide
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Rising Pharmaceuticals, Temozolomide
- Product type
- Temozolomide Capsules, 5mg
- Model numbers
- Lot #: 1TM0524003A
- UPC codes
- 16571-816, 16571-817, 16571-818, 16571-819, 16571-820, 16571-821, 16571-816-51, 16571-816-02 +8 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
March 3, 2026
Reported by FDA DRUG
March 11, 2026
RecallRadar source check
March 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Rising Pharma Holding, Inc. or your healthcare provider for guidance. Notification method: Letter
About This Product
Temozolomide is a chemotherapy drug used in brain cancer treatment. The recall concerns impurities and degradation detected in stability testing.
Why This Is Dangerous
Out-of-spec impurities can cause unknown toxicity or reduced drug efficacy. A stability failure indicates potential safety risk.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Patients relying on Temozolomide may experience disruption in treatment. The recall affects 1,200 bottles nationwide and requires medical guidance.
Practical Guidance
How to identify if yours is affected
- Check lot 1TM0524003A on the bottle
- Confirm Exp 09/2026 and 5 mg dosage
Where to find product info
NDC, lot number, and expiration appear on the bottle label. The recall URL provides official details.
What timeline to expect
Refunds or replacements, if offered, typically take 4-8 weeks after submission.
If the manufacturer is unresponsive
- Document all communications with the manufacturer.
- If the company is slow, contact the FDA recall page for guidance and report delays.
- Consult your clinician for alternative treatments and prescriptions if needed.
How to prevent similar issues
- Always verify NDC and lot numbers before dispensing Rx drugs.
- Obtain Rx drugs from licensed pharmacies only.
- Keep recall notices with medical records for future reference.
Documentation advice
Keep packaging, recall notification, and all correspondence for records.
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Product Details
NDC: 16571-816-51. Lot: 1TM0524003A. Expiration: 09/2026. Quantity: 1,200 bottles. Distribution: Nationwide in the U.S. Manufactured for: Rising Pharmaceuticals, Allendale, NJ 07401. Country of origin: Taiwan.
Key Facts
- 1,200 bottles recalled nationwide
- Reason: out-of-spec impurities/degradation in stability testing
- Remedy: stop use and contact physician or manufacturer
- Recall status: ACTIVE; Hazard level HIGH
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Safety Guide
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