# FDA recall D-0539-2023

> **Ascend Laboratories, LLC** · Class II · drug recall initiated 2023-03-17.

## Product

Aripiprazole Tablets, USP, 20 mg, Rx Only, Packaged in 500-count bottle Manufactured by:  Alkem Laboratories Ltd., INDIA  Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC#: 67877-434-05

## Reason for recall

Out of specification (OOS) for Spectroscopic Identification test by IR.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0539-2023
- **Recalling firm:** Ascend Laboratories, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2023-03-17
- **Report date:** 2023-04-26

- **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-0539-2023

## Citation

> AI Analytics. FDA recall D-0539-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0539-2023. Source: US FDA. Licensed CC0.

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