Recall: D-0384-2026

Class II - Potentially Harmful

Class IIClassification

2026-03-03Initiated

OngoingStatus

Rising Pharma Holding, Inc.Firm

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

Distribution

Nationwide within the U.S

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.