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.
| Source | FDA Drug Enforcement |
|---|---|
| Category | Drug |
| Severity | Medium |
| Status | ongoing |
| Recall date | March 03, 2026 |
| Reported | March 11, 2026 |
| Recalling firm | Rising Pharma Holding, Inc. |
| Country / region | United States NJ |
Hazard
Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
Affected products
- Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx only, Manufactured for: Rising Pharmaceuticals, Inc., Allendale, NJ 07401, Country
Related recalls
Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials, Rx only, Mfd. for Sagent PharmacPrimidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, MG217 Multi-Symptom Treatment Cream & Skin Protectant (colloidal oatmeal 2%), NET WT 6 oz (170 g), ManufactureLiraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, Fcimzia (certolizumab pegol), 2x200mg/mL PREFILLED SYRINGES (2 single-dose), Rx ONLY, Manufactured by: UCB Inc.