Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Dofetilide Capsules 250 mcg (0.25 mg) 60-count bottle Recalled by Accord Healthcare, Inc. Due to CGMP Deviations: recalling drug products following an FDA...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Accord Healthcare, Inc. directly.
Affected Products
Dofetilide Capsules 250 mcg (0.25 mg) 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA NDC 16729-491-12 UPC 3 16729 49112 9
Quantity: 113,571 bottles
Why Was This Recalled?
CGMP Deviations: recalling drug products following an FDA inspection.
Where Was This Sold?
United States including Puerto Rico and Canada
About Accord Healthcare, Inc.
Accord Healthcare, Inc. has 76 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report