FDA Drugs recall ·
Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles… recall
- Recall number
- D-0384-2026
- Date
- (initiated March 3, 2026)
- Company / brand
- Rising Pharma Holding, Inc.
2 Tower Center Blvd Ste 1401, East Brunswick, NJ, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1200 bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #: 1TM0524003A, Exp. Date 09/2026.
Distribution
Nationwide within the U.S
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0384-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.