Rising Pharma recalls carbidopa, levodopa, entacapone tablets over mix-up in tablet strength
A sealed bottle labeled as 25 mg/100 mg/200 mg tablets was found to hold higher-strength 37.5 mg/150 mg/200 mg tablets, so a patient could take a different dose than the label says.
What to do
The notice does not give instructions. Read the official notice for details.
Note from Recalled Today: Don't stop taking a prescribed medicine before you talk to your pharmacist or doctor.
Recall details
- 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
- Company
- Rising Pharma Holding, Inc.
- 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).
- Units
- 2,064 100-count bottles
- Where sold
- Distributed Nationwide in the USA
- FDA classification
- Class II · Ongoing
- Classified by FDA
- October 16, 2025
- Recall started
- October 7, 2025
- FDA enforcement report
- October 22, 2025
- Identifiers
- Codes: Lot # CS25070, exp. date 03/31/2027
- FDA recall number: D-0029-2026
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- 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 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).
- Classification
- Class II (Ongoing)
- Distribution
- Distributed Nationwide in the USA
- Quantity
- 2,064 100-count bottles
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