Class II

Drug Recall: 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

Rising Pharma Holding, Inc. · November 19, 2024

Reason for Recall

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

Distribution

Nationwide.

States Affected

NATIONWIDE

Quantity Affected

209,376 bottles

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0105-2025

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.

Rising Pharma Holding, Inc. Drug Recall: 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 | SafeCheck