FDAFDA · Food and drugs·Recall number D-0029-2026
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
Published October 22, 2025 · Recall initiated: October 7, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- CARBIDOPA, LEVODOPA AND ENTACAPONE
- Manufacturer
- Rising Pharma Holding, Inc.
- Distributor
- Distributed Nationwide in the USA
- UPC
- 0316571690015
- Lot
- Lot # CS25070, exp. date 03/31/2027
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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