Drug recall D-0384-2026
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
Lots and codes
Lot #: 1TM0524003A, Exp. Date 09/2026.
Recall details
- Recalling firm
- Rising Pharma Holding, Inc., East Brunswick, NJ
- Quantity
- 1200 bottles
- Distribution
- Nationwide within the U.S
- Type
- Voluntary: Firm initiated
- Recall initiated
- March 3, 2026
Related products
- Temozolomide – drug information
- NDC 16571-821 Temozolomide · Temozolomide 250 mg/1 · Rising Pharma Holdings, Inc.
- NDC 16571-818 Temozolomide · Temozolomide 100 mg/1 · Rising Pharma Holdings, Inc.
- NDC 16571-819 Temozolomide · Temozolomide 140 mg/1 · Rising Pharma Holdings, Inc.
- NDC 16571-817 Temozolomide · Temozolomide 20 mg/1 · Rising Pharma Holdings, Inc.
- NDC 16571-816 Temozolomide · Temozolomide 5 mg/1 · Rising Pharma Holdings, Inc.
- NDC 16571-820 Temozolomide · Temozolomide 180 mg/1 · Rising Pharma Holdings, Inc.