Rising Pharma Holding, Inc.: Carbidopa, Levodopa, Entacapone Tablets, 25 mg/100 mg/200 mg,

Rising Pharma Holding, Inc.: Carbidopa, Levodopa, Entacapone Tablets, 25 mg/100 mg/200 mg, 100-count bottle, Rx Only, Manufactured for: Rising Pharma Holdings, Inc. East

DrugsSource: FDA (drug) · Date: 2025-10-22

The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand: Rising Pharma Holding, Inc.
Product: 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
Reason / hazard: 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).
Classification: Class II
Status: Ongoing
Distribution / sold at: Distributed Nationwide in the USA
Recall initiated: 2025-10-07
Code info: Lot # CS25070, exp. date 03/31/2027
Product quantity: 2,064 100-count bottles
Voluntary mandated: Voluntary: Firm initiated
City: East Brunswick
State: NJ
Country: United States
Event id: 97768