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
Other Recalls by Rising Pharma Holding, Inc.
- Class II: Risk 03/05/2025
- Class II: Risk 12/30/2024
- Class II: Risk 12/30/2024
- Class II: Risk 12/30/2024
- Class II: Risk 11/19/2024
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.