FDA Drug recall D-1082-2023
Dofetilide Capsules 500 mcg (0.5mg), 60-count bottle, Rx Only, Manufactured by Sun Pharmaceutical Industries Limited, Survey No. 259/15, Da…
- FDA Drug
- Class III
- terminated
- Published 2023-08-16
On 2023-08-16 the FDA classified a Class III recall of Dofetilide Capsules 500 mcg (0.5mg), 60-count bottle, Rx Only, Manufactured by Sun Pharmaceutical Industries Limited, Survey No. 259/15, Da… by Sun Pharmaceutical Industries, citing out of Specification result observed in content uniformity testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1082-2023 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2023-07-18 |
| Published | 2023-08-16 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sun Pharmaceutical Industries |
| Distribution | US |
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
Out of Specification result observed in content uniformity testing
Identifiers
| ndc | 47335-061-86 |
|---|---|
| ndc | 47335-061-66 |
| ndc | 47335-061-79 |
| ndc | 47335-062-86 |
| ndc | 47335-062-66 |
| ndc | 47335-062-79 |
| ndc | 47335-063-86 |
| ndc | 47335-063-66 |
| ndc | 47335-063-79 |
| code_info | Lot: DNE0217A, Exp 01/2025 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1082-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.