Carvedilol 25 mg Tablet — Class II drug recall D-0217-2025
Terminated recall by RemedyRepack Inc., reported 2025-02-12, distributed in FL. CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable int
| Recall number | D-0217-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | RemedyRepack Inc., Indiana, PA, United States |
| Recall initiated | 2025-01-24 |
| Classified | 2025-02-03 |
| Reported by FDA | 2025-02-12 |
| Terminated | 2025-07-17 |
| Distributed | FL |
| Quantity | 247 blister |
| Reason classes | cgmp, specification failure |
| NDC | 70518-3945-00 |
| Lot numbers | J0777493050824, J0787856062124 |
| Expiration dates | 2025-05-31, 2025-07-31 |
Product
Carvedilol 25 mg Tablet, QTY: 30 Tablets per Blister Pack (3 x 10 blister cards), Rx Only, MFG by: Glenmark, Mahwah, NJ 07430, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC: 70518-3945-00.
Reason for recall
CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.
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-0217-2025. 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.