Class II

Drug Recall: Duloxetine Delayed-Release Capsules USP 30 mg, a) 30 count (NDC 57237-018-30) and b) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ

Rising Pharma Holding, Inc. · December 30, 2024

Reason for Recall

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

Distribution

Nationwide

States Affected

NATIONWIDE

Quantity Affected

42,527 bottles

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0188-2025

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 30 mg, a) 30 count (NDC 57237-018-30) and b) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ | SafeCheck