Carvediol Tablets — Class III drug recall D-1507-2016
Terminated recall by Sun Pharmaceutical Industries, Inc., reported 2016-09-28, distributed nationwide. Failed Impurities/Degradation Specifications
| Recall number | D-1507-2016 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sun Pharmaceutical Industries, Inc., Cranbury, NJ, United States |
| Recall initiated | 2016-06-27 |
| Classified | 2016-09-16 |
| Reported by FDA | 2016-09-28 |
| Terminated | 2018-03-26 |
| Distributed | Nationwide (US) |
| Quantity | 3,889 hdpe |
| Reason classes | specification failure |
| NDC | 57664-0247-13, 57664-0247-18, 57664-0247-88 |
| Lot numbers | 02/17, AVF0258/A, AVF0258/B, AVF0258/C, AVF0259/A, AVF0259/C |
Product
Carvediol Tablets, USP, 25 mg, 100-count bottle (NDC 57664-247-88), 500-count bottle (NDC 57664-247-13), 1000-count bottle (NDC 57664-247-18), Rx Only Manufactured by: ALKALOIDA Chemical Company Zrt 440 Tisavasvari Kabay Janos u. 29 Hungary, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512
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-1507-2016. 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.