March 2026 FDA Recall Temozolomide by Rising Pharma Holding, Inc.
D-0384-2026 - Failed Impurities/Degradation Specifications
This Class II drug recall was voluntarily initiated by Rising Pharma Holding, Inc. on March 3, 2026 for the product Temozolomide. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0384-2026
Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
03-03-2026
03-11-2026
1200 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Rising Pharma Holding, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the U.S
Product Description About Product Description
Full technical description of the product.
Full technical description of 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.
Batch or Lot Expiration Information
Lot# : 1TM0524003A, Exp. Date 09/2026.
