# FDA recall D-0735-2026

> **Ascend Laboratories, LLC** · Class III · drug recall initiated 2026-06-30.

## Product

Dabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), Rx Only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7254-68.

## Reason for recall

Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.

## Distribution

USA Nationwide

## Key facts

- **Recall number:** D-0735-2026
- **Recalling firm:** Ascend Laboratories, LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2026-06-30
- **Report date:** 2026-07-29

- **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-0735-2026

## Citation

> AI Analytics. FDA recall D-0735-2026. Retrieved 2026-08-31 from https://api.ai-analytics.org/recall/D-0735-2026. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*