# FDA recall D-0469-2025

> **Ascend Laboratories, LLC** · Class II · drug recall initiated 2025-05-23.

## Product

Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascent Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-544-68

## Reason for recall

Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis.    The individual impurity was identified to be Cephalexin Glucose Adduct.

## Distribution

Nationwide in the USA.

## Key facts

- **Recall number:** D-0469-2025
- **Recalling firm:** Ascend Laboratories, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-05-23
- **Report date:** 2025-06-18

- **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-0469-2025

## Citation

> AI Analytics. FDA recall D-0469-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0469-2025. Source: US FDA. Licensed CC0.

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