Rising Pharma Holding, Inc. recalls Product label: Temozolomide Capsules
- Recalling company
- Rising Pharma Holding, Inc.
- 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
- Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Mar 3, 2026
- Reported
- Mar 11, 2026
- Distribution
- Nationwide within the U.S
- Status
- Ongoing
- Quantity
- 1200 bottles
- Lot / codes
- Lot #: 1TM0524003A, Exp. Date 09/2026.
- Company location
- East Brunswick, NJ
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0384-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0384-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.