# FDA recall D-0130-2025

> **Ascend Laboratories, LLC** · Class II · drug recall initiated 2024-12-12.

## Product

Dabigatran Etexilate, 150mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-475-60

## Reason for recall

CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0130-2025
- **Recalling firm:** Ascend Laboratories, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-12-12
- **Report date:** 2024-12-18

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0130-2025

## Citation

> AI Analytics. FDA recall D-0130-2025. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-0130-2025. Source: US FDA. Licensed CC0.

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