FDAFDA · Food and drugs·Recall number D-0384-2026
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.
Published March 11, 2026 · Recall initiated: March 3, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- TEMOZOLOMIDE
- Manufacturer
- Rising Pharma Holding, Inc.
- Distributor
- Nationwide within the U.S
- Lot
- Lot #: 1TM0524003A, Exp. Date 09/2026.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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