Rising Pharma Holding, Inc.: Drug Recall

Recall #D-0029-2026 · 10/07/2025

Class II: Risk

Recall Details

Recall Number
D-0029-2026
Classification
Class II
Product Type
Drug
Recalling Firm
Rising Pharma Holding, Inc.
Status
Ongoing
Date Initiated
10/07/2025
Location
East Brunswick, NJ, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2,064 100-count bottles

Reason for Recall

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).

Product Description

Carbidopa, Levodopa, Entacapone Tablets, 25 mg/100 mg/200 mg, 100-count bottle, Rx Only, Manufactured for: Rising Pharma Holdings, Inc. East Brunswick, NJ, 08816, Manufactured by Suven Pharmaceuticals Limited, Pashamylaram, Telangana, 205307, India. NDC# 16571-691-01

Distribution Pattern

Distributed Nationwide in the USA

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.