FDA Drug · D-0384-2026

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.

Class II · Ongoing

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

Affected lots / codes — check yours against thisLot #: 1TM0524003A, Exp. Date 09/2026.

Recalling firm: Rising Pharma Holding, Inc., East Brunswick, NJ
Classification: Class II (temporary or reversible harm possible)
Status: Ongoing
Quantity: 1200 bottles
Distribution: Nationwide within the U.S
Recall initiated: March 3, 2026
Classified: March 4, 2026
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0384-2026%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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