Product label: Temozolomide Capsules — Class II drug recall D-0384-2026
Ongoing recall by Rising Pharma Holding, Inc., reported 2026-03-11, distributed nationwide. Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long te
| Recall number | D-0384-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Rising Pharma Holding, Inc., East Brunswick, NJ, United States |
| Recall initiated | 2026-03-03 |
| Classified | 2026-03-04 |
| Reported by FDA | 2026-03-11 |
| Distributed | Nationwide (US) |
| Quantity | 1,200 bottles |
| Reason classes | specification failure |
| NDC | 16571-0816, 16571-0816-02, 16571-0816-41, 16571-0816-51, 16571-0817, 16571-0817-02, 16571-0817-41, 16571-0817-51, 16571-0818, 16571-0818-02, 16571-0818-41, 16571-0818-51, 16571-0819, 16571-0819-02, 16571-0819-41, 16571-0819-51, 16571-0820, 16571-0820-02, 16571-0820-41, 16571-0820-51, 16571-0821, 16571-0821-02, 16571-0821-51 |
| Lot numbers | 1TM0524003A |
| Expiration dates | 2026-09 |
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 for recall
Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0384-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.