Carbidopa, Levodopa, Entacapone Tablets Recall: Rising Pharma 25/100/200
Announced 2026-07-29 · FDA
FDA is recalling Rising Pharma Carbidopa, Levodopa, Entacapone tablets due to a packaging mix-up where bottles labeled 25 mg/100 mg/200 mg contained 37.5 mg/150 mg/200 mg instead. The recall covers 2,064 bottles (100-count) distributed nationwide; Lot CS25070, exp 03/31/2027. The product is Rx only and manufactured for Rising Pharma Holdings, Inc.; no corrective action details are provided.
| Brand | Rising Pharma Holding, Inc. |
|---|---|
| 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 | 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). |
| Severity | moderate |
| Units affected | 74208 |
| Distribution | Distributed Nationwide in the USA |
| Agency | FDA |
| Recall / campaign no. | Lot # CS25070, exp. date 03/31/2027 |
WHAT YOU SHOULD DO
- Do not take this product.
- If you have the affected lot (CS25070, exp 03/31/2027), stop using it and contact your healthcare provider or pharmacist.
- Return the product to the place of purchase or follow FDA instructions for disposal.
- If you have experienced adverse effects, contact your clinician and report to FDA MedWatch.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.