Recalls / Class II
Class IID-0029-2026
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
- Brand name
- Carbidopa, Levodopa And Entacapone
- Generic name
- Carbidopa, Levodopa And Entacapone
- Active ingredients
- Carbidopa, Entacapone, Levodopa
- Route
- Oral
- NDCs
- 16571-689, 16571-690, 16571-691, 16571-692, 16571-693, 16571-694
- FDA application
- ANDA213212
- Affected lot / code info
- Lot # CS25070, exp. date 03/31/2027
Why it was recalled
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).
Recalling firm
- Firm
- Rising Pharma Holding, Inc.
- Manufacturer
- Rising Pharma Holdings, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Tower Center Blvd Ste 1401, East Brunswick, New Jersey 08816-1149
Distribution
- Quantity
- 2,064 100-count bottles
- Distribution pattern
- Distributed Nationwide in the USA
Timeline
- Recall initiated
- 2025-10-07
- FDA classified
- 2025-10-16
- Posted by FDA
- 2025-10-22
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0029-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.