FDA Drug recall D-0029-2026
Carbidopa, Levodopa, Entacapone Tablets, 25 mg/100 mg/200 mg, 100-count bottle, Rx Only, Manufactured for: Rising Pharma Holdings, Inc
- FDA Drug
- Class II
- ongoing
- Published 2025-10-22
On 2025-10-22 the FDA classified a Class II recall of Carbidopa, Levodopa, Entacapone Tablets, 25 mg/100 mg/200 mg, 100-count bottle, Rx Only, Manufactured for: Rising Pharma Holdings, Inc by Rising Pharma Holding, citing 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 lowe….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0029-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-10-07 |
| Published | 2025-10-22 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Rising Pharma Holding |
| Distribution | US |
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).
Identifiers
| ndc | 16571-689-01 |
|---|---|
| ndc | 16571-690-01 |
| ndc | 16571-691-01 |
| ndc | 16571-692-01 |
| ndc | 16571-693-01 |
| ndc | 16571-694-01 |
| code_info | Lot # CS25070, exp. date 03/31/2027 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
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FDA Drug · Class II · 2025-01-15 · Rising Pharma Holding - Duloxetine Delayed-Release Capsules USP 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ N…
FDA Drug · Class II · 2025-01-15 · Rising Pharma Holding
All Rising Pharma Holding recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0029-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.