# FDA recall D-0217-2025

> **RemedyRepack Inc.** · Class II · drug recall initiated 2025-01-24.

## Product

Carvedilol 25 mg Tablet, QTY: 30 Tablets per Blister Pack (3 x 10 blister cards), Rx Only, MFG by: Glenmark, Mahwah, NJ 07430, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC: 70518-3945-00.

## Reason for recall

CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.

## Distribution

FL

## Key facts

- **Recall number:** D-0217-2025
- **Recalling firm:** RemedyRepack Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2025-01-24
- **Report date:** 2025-02-12
- **Termination date:** 2025-07-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Indiana, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0217-2025

## Citation

> AI Analytics. FDA recall D-0217-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/D-0217-2025. Source: US FDA. Licensed CC0.

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