Recall
FDAHealthOctober 7, 2025

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 Brunswick, NJ, 08816, Manufac

⚠️ 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).

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
October 7, 2025

Distributed Nationwide in the USA

What's affected?

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
UPC
0316571690015
Lot code
CS25070

Additional details

Lot # CS25070, exp. date 03/31/2027

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 2,064 100-count bottles.

View original FDA notice →

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