Class IIOngoing

Product label: Temozolomide Capsules recall

FDA recall D-0384-2026 · initiated Mar 3, 2026

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing

Details

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.
Recalling company: Rising Pharma Holding, Inc.
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Nationwide within the U.S
Initiated: Mar 3, 2026
FDA report date: Mar 11, 2026

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0384-2026 ↗

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