# FDA recall D-0541-2024

> **Rising Pharma Holding, Inc.** · Class III · drug recall initiated 2024-05-16.

## Product

Pregabalin Capsules 50mg, 1000-count bottle, Rx Only, Manufactured for: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, Manufactured by: Laurus Labs Limited, Anakapalli-531011, India, NDC 64980-411-10

## Reason for recall

Presence of Foreign Tablets/Capsules: Complaint received from a re-packager, American Health Packaging (AHP), where a foreign tablet was discovered in one of the bottles during packaging set up. Tablet identified as pantoprazole tablet 20mg.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0541-2024
- **Recalling firm:** Rising Pharma Holding, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-05-16
- **Report date:** 2024-06-12

- **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-0541-2024

## Citation

> AI Analytics. FDA recall D-0541-2024. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0541-2024. Source: US FDA. Licensed CC0.

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