Dofetilide Capsules — Class III drug recall D-0474-2023
Terminated recall by SUN PHARMACEUTICAL INDUSTRIES INC, reported 2023-03-29, distributed nationwide. Failed Content Uniformity Specifications
| Recall number | D-0474-2023 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ, United States |
| Recall initiated | 2023-03-09 |
| Classified | 2023-03-22 |
| Reported by FDA | 2023-03-29 |
| Terminated | 2023-10-18 |
| Distributed | Nationwide (US) |
| Quantity | 1,920 bottles |
| NDC | 47335-0063-86 |
| Lot numbers | DND1541A |
| Expiration dates | 2024-08 |
Product
Dofetilide Capsules, 500 mcg (0.5 mg), 60-count bottle, Rx only, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India, NDC 47335-0063-86
Reason for recall
Failed Content Uniformity 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-0474-2023. 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.