FDA Recalls Dofetilide Antiarrhythmic Drug for Manufacturing Deviations
Accord Healthcare is recalling Dofetilide antiarrhythmic capsules due to manufacturing compliance deviations identified during FDA inspection. The recall affects approximately 113,003 bottles distributed in the U.S., Puerto Rico, and Canada.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall without reported illnesses or injuries and no specific identified safety hazard. Manufacturing compliance deviations are treated as precautionary, warranting Moderate severity.
Plain-English summary
Accord Healthcare, Inc. is recalling Dofetilide 500 mcg antiarrhythmic capsules distributed in the United States, Puerto Rico, and Canada. Approximately 113,003 bottles of the affected product have been distributed. The recall was initiated following an FDA inspection that identified manufacturing practice deviations at the producing facility. Affected batches have expiration dates ranging from February 2023 through May 2025. Patients currently taking Dofetilide should contact their healthcare provider to discuss their prescription and available treatment alternatives.
The recalled product
- Product
- DOFETILIDE (DOFETILIDE)
- Brand
- DOFETILIDE
- Manufacturer
- Accord Healthcare, Inc.
- Hazard
- Affected units
- 113,003
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: 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
UPCs (1)
- 316729492126
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 →Related recalls
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- HighDofetilide antiarrhythmic prescription drug recalled for manufacturing deviations
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