Class II
Ongoing
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
This recall is currently active, issued October 22, 2025. It was issued by Rising Pharma Holding, Inc..
- Company
- Rising Pharma Holding, Inc.
- Recall Initiated
- October 7, 2025
- Posted
- October 22, 2025
- Recall Number
- D-0029-2026
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 2,064 100-count bottles
- Firm Location
- East Brunswick, NJ, United States
- Official Source
- View on FDA website ↗
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).
Distribution
Distributed Nationwide in the USA
Lot / Code Info
Lot # CS25070, exp. date 03/31/2027
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