Warning
Rising Pharma Holding Recalls Product label: Temozolomide Capsules
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0384-2026Drug / Pharmaceutical
Rising Pharma Holding Recalls Product label: Temozolomide Capsules
Rising Pharma Holding, Inc. · Class II — Moderate Risk
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
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
Nationwide within the U.S
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
The FDA classified this recall as Class II, indicating the pharmaceutical product may cause temporary health problems or poses a slight threat of a serious nature. Rising Pharma Holding, Inc. initiated the recall on March 3, 2026 affecting 1200 bottles. Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing. The product was distributed nationwide. Consumers should check their purchases and discontinue use of any affected product. Contact Rising Pharma Holding, Inc. for further instructions.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medical Product Contamination.