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

Recall Number: D-0277-2025

Firm: Rising Pharma Holding, Inc.

Classification: Class II

Status: Ongoing

Report Date: 20250326

Initiation Date: 20250305

Termination Date:

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

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