Why it was recalled
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.
Lot numbers, UPCs & expiration codes
Lot #: 1TM0524003A, Exp. Date 09/2026.
Where it was sold
Nationwide within the U.S
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0384-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Mar 3, 2026
- FDA report date
- Mar 11, 2026
- Quantity
- 1200 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Rising Pharma Holding, Inc.
Original FDA data
Every field from FDA enforcement report D-0384-2026, exactly as published.
Show all FDA fields
- City
- East Brunswick
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 98523
- Address
- 2 Tower Center Blvd Ste 1401
- Code information
- Lot #: 1TM0524003A, Exp. Date 09/2026.
- Postal code
- 08816-1149
- Report date
- Mar 11, 2026
- Product type
- Drugs
- Recall number
- D-0384-2026
- Classification
- Class II
- Recalling firm
- Rising Pharma Holding, Inc.
- Product quantity
- 1200 bottles
- Reason for recall
- Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide within the U.S
- Recall initiation date
- Mar 3, 2026
- Initial firm notification
- Letter
- Center classification date
- Mar 4, 2026