Dofetilide Capsules Recalled for Failed Content Uniformity Specifications
Sun Pharmaceutical is recalling 1,920 bottles of Dofetilide Capsules (500 mcg) nationwide due to failed content uniformity specifications, meaning the capsules do not contain uniform amounts of active ingredient.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 2/5 (Moderate).
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 III recall with no reported illnesses or injuries. Content uniformity failure represents a manufacturing defect, but the Class III designation and absence of reported harm indicate moderate rather than high severity per the rubric.
Plain-English summary
Sun Pharmaceutical Industries Inc. is recalling Dofetilide Capsules, 500 mcg (0.5 mg) supplied in 60-count bottles nationwide in the United States. The recalled product is identified by NDC 47335-0063-86, Lot # DND1541A, with expiration date 08/2024.
The recall was initiated due to failed content uniformity specifications, meaning the capsules do not contain uniform amounts of the active ingredient dofetilide across the batch.
Consumers who have this medication should not use it and should contact their healthcare provider or pharmacist for guidance on obtaining replacement medication. Adverse events may be reported to the FDA at 1-888-SAFEFDA or online at www.fda.gov/medwatch.
The recalled product
- 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
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug — Antiarrhythmic
- Hazard
- Affected units
- 1,920
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 (2)
- Lot # DND1541A
- Exp 08/2024
Distribution
Distributed nationwide across the United States.
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