FDA Drug recall D-0384-2026
Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx only, Manufactured for: Rising Pharmaceuticals, Inc., Allendal…
- FDA Drug
- Class II
- ongoing
- Published 2026-03-11
On 2026-03-11 the FDA classified a Class II recall of Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx only, Manufactured for: Rising Pharmaceuticals, Inc., Allendal… by Rising Pharma Holding, citing failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0384-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-03-03 |
| Published | 2026-03-11 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Rising Pharma Holding |
| Distribution | US |
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.
Reason
Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
Identifiers
| ndc | 16571-816-51 |
|---|---|
| ndc | 16571-816-02 |
| ndc | 16571-816-41 |
| ndc | 16571-817-51 |
| ndc | 16571-817-02 |
| ndc | 16571-817-41 |
| ndc | 16571-818-51 |
| ndc | 16571-818-02 |
| ndc | 16571-818-41 |
| ndc | 16571-819-51 |
| ndc | 16571-819-02 |
| ndc | 16571-819-41 |
| ndc | 16571-820-51 |
| ndc | 16571-820-02 |
| ndc | 16571-820-41 |
| ndc | 16571-821-51 |
| ndc | 16571-821-02 |
| code_info | Lot #: 1TM0524003A, Exp. Date 09/2026. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
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FDA Drug · Class II · 2025-01-15 · Rising Pharma Holding
All Rising Pharma Holding recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0384-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.