FDAHealthMarch 3, 2026
Rising Pharma Holding, Inc. — Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx only, Manufactured for: Rising Pharmaceuticals, Inc., Allendale, NJ 07401, Country of origin:
⚠️ Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- March 3, 2026
Nationwide within the U.S
What's affected?
- 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.
- Brand
- TEMOZOLOMIDE
- Lot code
- 1TM0524003A
Additional details
Lot #: 1TM0524003A, Exp. Date 09/2026.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 1200 bottles.
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