Rising Pharma Holding, Inc. recalls Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx only, Manufactured for: Rising Pharmaceutic
Recalled March 11, 2026 · FDA recall D-0384-2026 · Rising Pharma Holding
Hazard
Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing · FDA Class II
Units
1200 bottles
Sold at
Nationwide within the U.S
Description
Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
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.
Manufacturer(s)
Rising Pharma Holding, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →