Data Composite

Recall D-0384-2026

US Class II Ongoing · initiated 2026-03-03

Recalling firm

Rising Pharma Holding, Inc., NJ

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

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