Class II

Drug Recall: 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.

Rising Pharma Holding, Inc. · March 3, 2026

Reason for Recall

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

Distribution

Nationwide within the U.S

States Affected

NATIONWIDE

Quantity Affected

1200 bottles

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0384-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.