Temozolomide Capsules — Class III drug recall D-0344-2019
Terminated recall by Amerigen Pharmaceuticals Inc., reported 2019-01-02. Failed Dissolution Specifications
| Recall number | D-0344-2019 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Amerigen Pharmaceuticals Inc., Lyndhurst, NJ, United States |
| Recall initiated | 2018-12-20 |
| Classified | 2018-12-26 |
| Reported by FDA | 2019-01-02 |
| Terminated | 2019-12-17 |
| Quantity | 3,552 bottles |
| Reason classes | specification failure |
| NDC | 43975-0253-05, 43975-0253-14 |
| Lot numbers | 18B005A, 18B005B |
| Expiration dates | 2020-02 |
Product
Temozolomide Capsules, 20 mg, packaged in a a) 5-count (NDC 43975-253-05) and b) 14 count (NDC 43975-253-14) bottles, Rx only, Mfd, by: Stason Pharmaceuticals, Inc., Irvine, CA, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ
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-0344-2019. 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.