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
Rising Pharmaceuticals is recalling Temozolomide Capsules, 5mg, packaged in 5-capsule bottles (NDC 16571-816-51) due to failed impurities and degradation specifications observed during stability testing. The affected product was manufactured in Taiwan and distributed nationwide.
Is mine affected?
Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.
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.
- Recall #
- D-0384-2026
Where it was sold
Distributed nationwide.
Official source
Other recent recalls from Rising Pharma Holding, Inc.
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