Dofetilide Capsules (Sun Pharma) – Content Uniformity Issue (2023)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Dofetilide Capsules 500 mcg (0.5mg), 60-count bottle, Rx Only, Manufactured by Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T of D & NH), India, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512. NDC 47335-063-86
Brand
SUN PHARMACEUTICAL INDUSTRIES INC
Lot Codes / Batch Numbers
Lot: DNE0217A, Exp 01/2025
Products Sold
Lot: DNE0217A, Exp 01/2025
SUN PHARMACEUTICAL INDUSTRIES INC is recalling Dofetilide Capsules 500 mcg (0.5mg), 60-count bottle, Rx Only, Manufactured by Sun Pharmaceutical In due to Out of Specification result observed in content uniformity testing. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Out of Specification result observed in content uniformity testing
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026