Temozolomide Capsules — Class III drug recall D-0516-2019
Terminated recall by Amerigen Pharmaceuticals Inc., reported 2019-02-27, distributed nationwide. Failed dissolution specifications
| Recall number | D-0516-2019 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Amerigen Pharmaceuticals Inc., Lyndhurst, NJ, United States |
| Recall initiated | 2019-02-19 |
| Classified | 2019-02-20 |
| Reported by FDA | 2019-02-27 |
| Terminated | 2019-12-17 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 43975-0252-05, 43975-0252-14 |
| Expiration dates | 2020-09-30 |
Product
Temozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 43975-252-05) b) 14-count bottle (NDC 43975-252-14), Rx only, Mfd. by: Stason Pharmaceuticals, Inc., Irvine, CA 92618, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ 07071
Reason for recall
Failed dissolution specifications
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-0516-2019. 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.