Rising Pharma Holding, Inc. recalls Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only, Distributed by: Rising Health, LLC, Saddle
Recalled March 26, 2025 · FDA recall D-0277-2025 · Rising Pharma Holding
Hazard
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit. · FDA Class II
Units
1223 bottles
Sold at
Nationwide in the USA.
Description
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Product
Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC 57237-018-99
Manufacturer(s)
Rising Pharma Holding, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →