Product label: Temozolomide Capsules recall (Rising Pharma Holding, Inc.)
DrugClass IIOngoing
Summary: Rising Pharma Holding, Inc. is recalling 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.. Reason: Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing.
What is 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.
Why
Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Nationwide within the U.S
How to tell if yours is affected
Lot #: 1TM0524003A, Exp. Date 09/2026.
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0384-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | March 3, 2026 |
| Reported | March 11, 2026 |
| Company | Rising Pharma Holding, Inc. |
| Company location | East Brunswick, NJ, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 1200 bottles |
More recalls from Rising Pharma Holding, Inc. · all drug recalls · recalls from March 2026