Rising Pharma Holding, Inc. recalls Duloxetine Delayed-Release Capsules USP, 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc.,
Recalled December 11, 2024 · FDA recall D-0105-2025 · Rising Pharma Holding
Hazard
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit · FDA Class II
Units
209,376 bottles
Sold at
Nationwide.
Description
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
Product
Duloxetine Delayed-Release Capsules USP, 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ NDC 57237-017-60
Manufacturer(s)
Rising Pharma Holding, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →