FDA-Drug2023-08-16Class III
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
Hazard
Out of Specification result observed in content uniformity testing
Sold states
Nationwide in the USA
Affected count
360 60-count bottles
Manufactured in
2 Independence Way, N/A, Princeton, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1082-2023More SUN PHARMACEUTICAL INDUSTRIES INC recalls
- FDA-Drug2026-06-17Sun Pharmaceutical budesonide inhalation suspension recalled for foreign particles
- FDA-Drug2026-06-17Sun Pharmaceutical doxorubicin injection recalled for glass particles
- FDA-Drug2026-04-22Taro Fluocinonide 0.05% Cream recalled for failed viscosity specifications
- FDA-Drug2026-04-22Taro Pharmaceuticals fluocinonide cream recalled for failed viscosity specifications
- FDA-Drug2026-04-22Taro Pharmaceuticals fluocinonide 0.05% cream recalled for viscosity defect
Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief