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Medium risk Drugs & MedicationsClass II

Rising Pharma Temozolomide 5mg Recall

Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx only, Manufactured for: Rising Pharmaceuticals, Inc., Allendale

Updated March 3, 2026

Rising Pharmaceuticals is recalling Temozolomide Capsules 5mg due to impurities found during stability testing. The capsules may contain unwanted chemical degradation that could affect the medication's safety or effectiveness.

Is the Rising Pharma Holding, Inc. recalled? Yes. This product was recalled by FDA on March 3, 2026. Details below.

What is recalled

Temozolomide Capsules, 5mg, packaged in 5-capsule bottles. NDC 16571-816-51. Manufactured for Rising Pharmaceuticals, Inc., Allendale, NJ 07401. Country of origin: Taiwan.

Am I affected

You're affected if your prescription bottle shows NDC 16571-816-51 and contains Temozolomide 5mg capsules in 5-capsule packaging from Rising Pharmaceuticals.

What to do right now

Contact your pharmacist or doctor right away about this recall. Do not stop taking Temozolomide without medical guidance, your doctor will advise whether to switch to another supply or continue with your current dose while a replacement is arranged.

The hazard

Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing

Brands affected

Rising Pharma Holding, Inc.
Source
FDA
Category
Drugs & Medications
Recall ID
fda-D-0384-2026
Classification
Class II
Recalled
March 3, 2026
Read the official notice

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