Product: Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx only, Manufactured for: Rising Pharmaceuticals, Inc., Allendale, NJ 07401, Country of origin: Taiwan, NDC 16571-816-51.
Reason for recall: Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
Recall initiated: 20260303
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated