Rising Pharma Holding, Inc.: Drug Recall

Recall #D-0188-2025 · 12/30/2024

Class II: Risk

Recall Details

Recall Number: D-0188-2025
Classification: Class II
Product Type: Drug
Recalling Firm: Rising Pharma Holding, Inc.
Status: Ongoing
Date Initiated: 12/30/2024
Location: East Brunswick, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 42,527 bottles

Reason for Recall

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

Product Description

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

Distribution Pattern

Nationwide

Other Recalls by Rising Pharma Holding, Inc.

Class II: Risk 10/07/2025

Product mix up: complaint received that sealed medication bottle contained Carbidopa, Levodopa, and Entacapone film-coated tablets (37.5 mg/150 mg/200 mg) instead of labelled lower strength Carbidopa, Levodopa, and Entacapone film-coated tablets (25 mg/100 mg/200 mg).
Class II: Risk 03/05/2025

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Class II: Risk 12/30/2024

CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Class II: Risk 12/30/2024

CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Class II: Risk 11/19/2024

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

View all recalls by Rising Pharma Holding, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.