# FDA recall D-0645-2025

> **Ascend Laboratories, LLC** · Class II · drug recall initiated 2025-08-28.

## Product

Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx only, Manufactured by: Alken Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.  NDC: 67877-432-03

## Reason for recall

Superpotent drug

## Distribution

Nationwide in the USA.

## Key facts

- **Recall number:** D-0645-2025
- **Recalling firm:** Ascend Laboratories, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-08-28
- **Report date:** 2025-09-24

- **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-0645-2025

## Citation

> AI Analytics. FDA recall D-0645-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0645-2025. Source: US FDA. Licensed CC0.

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