Recalls / Class II
Class IID-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.
- Brand name
- Temozolomide
- Generic name
- Temozolomide
- Active ingredient
- Temozolomide
- Route
- Oral
- NDCs
- 16571-816, 16571-817, 16571-818, 16571-819, 16571-820, 16571-821
- FDA application
- ANDA206309
- Affected lot / code info
- Lot #: 1TM0524003A, Exp. Date 09/2026.
Why it was recalled
Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
Recalling firm
- Firm
- Rising Pharma Holding, Inc.
- Manufacturer
- Rising Pharma Holdings, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Tower Center Blvd Ste 1401, N/A, East Brunswick, New Jersey 08816-1149
Distribution
- Quantity
- 1200 bottles
- Distribution pattern
- Nationwide within the U.S
Timeline
- Recall initiated
- 2026-03-03
- FDA classified
- 2026-03-04
- Posted by FDA
- 2026-03-11
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0384-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.