FDA recall D-0277-2025

Rising Pharma Holding, Inc. · Class II · drug

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

Reason for recall

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

Distribution

Nationwide in the USA.

Key facts

Status: Ongoing
Initiation date: 2025-03-05
Report date: 2025-03-26
Voluntary/Mandated: Voluntary: Firm initiated
Location: East Brunswick, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0277-2025