The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0384-2023·Announced 2023-03-08

Dofetilide antiarrhythmic prescription drug recalled for manufacturing deviations

Accord Healthcare is recalling 113,571 bottles of dofetilide capsules distributed in the US, Puerto Rico, and Canada due to Current Good Manufacturing Practice (CGMP) deviations found during FDA inspection. No illnesses have been reported.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II drug recall, indicating potential for adverse health consequences, but no illnesses, injuries, or reported adverse effects are documented. The hazard is manufacturing non-compliance (CGMP deviations) without a specified safety defect.

Plain-English summary

Accord Healthcare, Inc. is recalling dofetilide 250 mcg capsules sold in the United States, including Puerto Rico and Canada. The recall affects approximately 113,571 bottles. Dofetilide is an oral prescription antiarrhythmic medication.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations discovered during an FDA inspection. CGMP deviations indicate non-compliance with FDA manufacturing standards for quality and process control.

Multiple batch numbers are affected, with expiration dates ranging from February 2023 through May 2025. Patients currently taking dofetilide should not stop the medication without consulting their healthcare provider. Contact a healthcare professional or pharmacist to determine if your medication is affected and for guidance on appropriate next steps.

The recalled product

Product
DOFETILIDE (DOFETILIDE)
Brand
DOFETILIDE
Manufacturer
Accord Healthcare, Inc.
Category
Drug — Antiarrhythmic
Hazard
Affected units
113,571

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

UPCs (1)

  • 316729491129

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 67 recalled by Accord Healthcare, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 67 products in this recall →

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