Temozolomide capsules — Class III drug recall D-0249-2019
Terminated recall by Amerigen Pharmaceuticals Inc., reported 2018-10-24, distributed nationwide. Failed dissolution specifications: Out-of-Specification dissolution results obtained during stability testing.
| Recall number | D-0249-2019 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Amerigen Pharmaceuticals Inc., Lyndhurst, NJ, United States |
| Recall initiated | 2018-10-05 |
| Classified | 2018-11-15 |
| Reported by FDA | 2018-10-24 |
| Terminated | 2019-09-30 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 43975-0253-05, 43975-0253-14 |
Product
Temozolomide capsules, 20 mg, packaged in a) 5-count bottle(NCD 43975-253-05), b) 14-count bottle (NDC 43975-253-14), Rx only, Mfd. by: Stason Pharmaceuticals, Inc., Irvine, CA 92618, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ 07071.
Reason for recall
Failed dissolution specifications: Out-of-Specification dissolution results obtained during 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-0249-2019. 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.