Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx only, Manufactured f...
FDA Recall #D-0384-2026 — Class II — March 3, 2026
Product Description
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
Recalling Firm
Rising Pharma Holding, Inc. — East Brunswick, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
1200 bottles
Distribution
Nationwide within the U.S
Code Information
Lot #: 1TM0524003A, Exp. Date 09/2026.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated