United StatesTemozolomide Capsules, 5 mg, in 5-capsule bottles (NDC 16571-816-51), Lot 1TM0524003A, Exp. 09/2026, manufactured for Rising Pharmaceuticals (Allendale, NJ) with country of origin Taiwan, is being recalled by Rising Pharma Holding (East Brunswick, NJ); 1,200 bottles were distributed nationwide in the U.S. The recall was initiated because the product failed impurities/degradation specifications after an out-of-specification result observed during 9th-month long-term stability testing.
What's being recalled
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.
Recalling firm: Rising Pharma Holding, Inc., East Brunswick, NJ, United States.
How to identify it
Lot #: 1TM0524003A, Exp. Date 09/2026.
The hazard
Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Nationwide within the U.S
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)