Temozolomide Capsules 5mg
Rising Pharmaceuticals is recalling Temozolomide Capsules 5mg (NDC 16571-816-51) due to failed impurities and degradation specifications.
Do not use this medication. Contact your pharmacy or healthcare provider immediately to obtain a replacement or alternative treatment. Return the recalled product to your pharmacy.
Why it was recalled
Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
How to identify it
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.
Where it was sold
Distributed in US.
Official source
Editorial summary by Recall Canary · last updated 2026-04-27 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification