Dofetilide Capsules 500 mcg — Class III drug recall D-1082-2023
Terminated recall by SUN PHARMACEUTICAL INDUSTRIES INC, reported 2023-08-16, distributed nationwide. Out of Specification result observed in content uniformity testing
| Recall number | D-1082-2023 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ, United States |
| Recall initiated | 2023-07-18 |
| Classified | 2023-08-07 |
| Reported by FDA | 2023-08-16 |
| Terminated | 2024-02-26 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 47335-0061, 47335-0061-66, 47335-0061-79, 47335-0061-86, 47335-0062, 47335-0062-66, 47335-0062-79, 47335-0062-86, 47335-0063, 47335-0063-66, 47335-0063-79, 47335-0063-86 |
| Lot numbers | DNE0217A |
| Expiration dates | 2025-01 |
Product
Dofetilide Capsules 500 mcg (0.5mg), 60-count bottle, Rx Only, Manufactured by Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T of D & NH), India, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512. NDC 47335-063-86
Reason for recall
Out of Specification result observed in content uniformity 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-1082-2023. 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.