Class II

Drug Recall: 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

Rising Pharma Holding, Inc. · March 5, 2025

Reason for Recall

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit.

Distribution

Nationwide in the USA.

States Affected

NATIONWIDE

Quantity Affected

1223 bottles

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0277-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.