Isradapine Capsules USP 2 — Class III drug recall D-0107-2018
Terminated recall by Elite Laboratories Inc., reported 2017-12-13, distributed in NY. Failed Impurities/Degradation Specifications
| Recall number | D-0107-2018 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elite Laboratories Inc., Northvale, NJ, United States |
| Recall initiated | 2017-11-13 |
| Classified | 2017-12-05 |
| Reported by FDA | 2017-12-13 |
| Terminated | 2019-03-15 |
| Distributed | NY |
| Quantity | 1,264 bottles |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 00342806263013 |
| NDC | 42806-0263-01 |
| Lot numbers | P0910-017 |
| Expiration dates | 2019-05 |
Product
Isradapine Capsules USP 2.5 mg, 100-count bottles, Rx only, Manufactured by: Elite Laboratories, Inc. Northvale, NJ 07647, NDC 42806-263-01, UPC 342806263013
Reason for recall
Failed Impurities/Degradation 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-0107-2018. 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.