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.

Recall Number: D-0384-2026

Firm: Rising Pharma Holding, Inc.

Classification: Class II

Status: Ongoing

Report Date: 20260311

Initiation Date: 20260303

Termination Date:

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

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.