Class III · Low risk
Dofetilide Capsules 500 mcg
Out of Specification result observed in content uniformity testing
Dofetilide Capsules
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Content Uniformity Specifications
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
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
Affected NDC
47335-0063-86
Compare with the code on your package — it is the most precise check available.
Drug: Dofetilide
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Dofetilide NDC 47335-0063 |
.5 mg/1 | Capsule Oral |
Sun Pharmaceutical Industries, Inc. | Rx |
- Recalling firm
- Sun Pharmaceutical Industries INC
- NDC code
- 47335-0063-86
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0474-2023 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Dofetilide recalls
See all
Class II · Moderate risk
Dofetilide Capsules 500 mcg
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Dofetilide Capsules 250 mcg
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Dofetilide Capsules
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Tikosyn (dofetilide)
Failed Tablet/Capsule Specifications: Product being recalled due to the potential presence of cracked or broken capsules.
Other recalls by Sun Pharmaceutical Industries INC
All 2023 recalls
Unclassified
Nystatin Cream
Failed Stability Specifications
Class II · Moderate risk
Carbamazepine Tablets
CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing
Class II · Moderate risk
Perampanel CIII Tablets
Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.
Class III · Low risk
Fexofenadine Hydrochloride Tablets
Failed Impurities/Degradation Specifications
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