# FDA recall D-0738-2026

> **Ascend Laboratories, LLC** · Class III · drug recall initiated 2026-07-16.

## Product

Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7253-68.

## Reason for recall

Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability

## Distribution

USA Nationwide

## Key facts

- **Recall number:** D-0738-2026
- **Recalling firm:** Ascend Laboratories, LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2026-07-16
- **Report date:** 2026-08-05

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0738-2026

## Citation

> AI Analytics. FDA recall D-0738-2026. Retrieved 2026-09-01 from https://api.ai-analytics.org/recall/D-0738-2026. Source: US FDA. Licensed CC0.

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