Recalling firm
Rising Pharma Holding, Inc.
Product type
Drug
Status
Ongoing
Report date
2026-03-11
Distribution
Nationwide within the U.S
Firm state
NJ
Product quantity
1200 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & QualificationReason for recall
Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
Product description
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.
Code / lot info
Lot #: 1TM0524003A, Exp. Date 09/2026.
Other recalls SPEQ maps to Validation & Qualification
See all Validation & Qualification recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.