Drug & Device Safety Atlas

FDA drug recalls · openFDA

Is DOFETILIDE recalled?

The FDA has recorded 4 recalls of DOFETILIDE (2023) , recalled under brand like DOFETILIDE.

0
Class I (most serious)
3
Class II
1
Class III
0
ongoing

A recall doesn't mean your pills are affected

Drug recalls are issued by lot (specific batches, identified by lot numbers / NDC) — not for every bottle of DOFETILIDE ever made. To know if yours is involved, match the lot codes on the recall below against your bottle, or ask your pharmacist. Do not stop a prescribed medication because of a recall without talking to your pharmacist or prescriber — stopping can be more dangerous than the recall. The Class is the FDA's risk judgment (Class I = reasonable probability of serious harm or death), not a measurement that harm occurred; most recalls are voluntary and Class II/III.

Why it was recalled

CGMP Deviations: recalling drug products following an FDA inspection. 3
Out of Specification result observed in content uniformity testing 1

The recalls

Class I and ongoing recalls first. Tap a recall for its full record and lot detail.

Dofetilide Capsules 250 mcg (0.25 mg) 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27 Class II Terminated
Accord Healthcare, Inc. 2023-02-07 lots: Batches: P2101481 Exp. Date 2/28/2023; P2101985, P2101958, P2102019, Exp. Date 3/31/2023; P2102580, P2102597, Exp. Date 4/30/2023; P2104708, P2104712, Exp. Date 6/30/2023; P2107154, P2107187, Exp. Date 10/31/2023; P2107874, Exp. Date 11/30/2023; P2200772, P2200796, P2200830, Exp. Date 12/31/2023; P2201196, P2201198, Exp. Date 1/31/2024; P2200817, Exp. Date 12/31/2024; P2202610, Exp. Date 4/30/2025; P2203466, Exp. Date 5/31/2025;
Dofetilide Capsules 500 mcg (0.5 mg), 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27 Class II Terminated
Accord Healthcare, Inc. 2023-02-07 lots: Batches: P2101582, P2101661, P2101482, P2101686, Exp. Date 2/28/2023; P2102581, P2102598, Exp. Date 4/30/2023; P2103623, P2103653, P2103670, Exp. Date 5/31/2023; P2104463, P2104385, P2104386, P2104472, P2104709, P2104714, Exp. Date 6/30/2023; P2200797, P2200773, P2200831, Exp. Date 12/31/2023; P2201017, P2201081, P2201056, Exp. Date 1/31/2024; P2200819, Exp. Date 12/31/2024; P2202611, P2202616, Exp. Date 4/30/2025, P2203467, Exp. Date 5/31/2025
Dofetilide Capsules, 125 mcg (0.125 mg), 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC Class II Terminated
Accord Healthcare, Inc. 2023-02-07 lots: Batches: P2101480, Exp. Date 2/28/2023; P2102579, P2102596, Exp. Date 4/30/2023; P2104711, P2104707, Exp. Date 6/30/2023; P2200771, P2200829, P2200795, Exp. Date 12/31/2023; P2202608, Exp. Date 4/30/2025; P2203492, P2203463, Exp. Date 5/31/2025; P2205373, P2205412, Exp. Date 8/31/2025;
Dofetilide Capsules 500 mcg (0.5mg), 60-count bottle, Rx Only, Manufactured by Sun Pharmaceutical Industries Limited, Su Class III Terminated
SUN PHARMACEUTICAL INDUSTRIES INC 2023-07-18 lots: Lot: DNE0217A, Exp 01/2025

RECORDED — these are the FDA's published recall enforcement records (openFDA), grouped by the generic drug name. Scope: drug recalls the FDA recorded with a generic name; device recalls and recalls without a generic name are in the full recall browse. "Ongoing" reflects openFDA's last-published status — confirm current status and your lot at the FDA recall database. This page informs and routes; it is not medical advice.

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