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.

FDA recall notice · announced March 11, 2026 · Rising Pharma Holding

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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 for recall

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

Notes

Distribution: Nationwide within the U.S
Lot/code information: Lot #: 1TM0524003A, Exp. Date 09/2026.
Quantity: 1200 bottles
Status: Ongoing
Products in this recall event:
- 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. (D-0384-2026)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.