HIGH

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...

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).

Quick Facts at a Glance

Recall Date
October 7, 2025
Hazard Level
HIGH
Brands
CARBIDOPA, LEVODOPA AND ENTACAPONE, Rising Pharma Holdings, Inc.
Geographic Scope
1 states

Hazard Information

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).

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Rising Pharma Holding, Inc. or your healthcare provider for guidance. Notification method: Letter

Full 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. Generic: CARBIDOPA, LEVODOPA AND ENTACAPONE; Brand: CARBIDOPA, LEVODOPA AND ENTACAPONE. Reason: 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. Quantity: 2,064 100-count bottles. Distribution: Distributed Nationwide in the USA

View Original Recall on FDA - Drug Safety

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Product Classification

Product Details

Model Numbers
Lot # CS25070
exp. date 03/31/2027
UPC Codes
16571-689
16571-690
16571-691
+9 more
Affected States
ALL
Report Date
October 22, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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