# FDA recall D-0029-2026

> **Rising Pharma Holding, Inc.** · Class II · drug recall initiated 2025-10-07.

## 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).

## Distribution

Distributed Nationwide in the USA

## Key facts

- **Recall number:** D-0029-2026
- **Recalling firm:** Rising Pharma Holding, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-10-07
- **Report date:** 2025-10-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** East Brunswick, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0029-2026

## Citation

> AI Analytics. FDA recall D-0029-2026. Retrieved 2026-07-12 from https://api.ai-analytics.org/recall/D-0029-2026. Source: US FDA. Licensed CC0.

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