# FDA recall D-0540-2024

> **Bryant Ranch Prepack, Inc.** · Class III · drug recall initiated 2024-05-10.

## Product

Cephalexin for Oral Suspension, USP, 250mg/5mL, Rx only, 200mL (when mixed), Each contains cephalexin monohydrate, USP equivalent to 5g cephalexin. Manufactured by Alkem Laboratories Ltd, Relabeled by: Bryant Ranch Prepack, Inc, Burbank, CA 91504, NDC 63629-9207-1.

## Reason for recall

Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g'  instead of  Each Bottle contains: cephalexin monohydrate, USP equivalent to 10g'

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0540-2024
- **Recalling firm:** Bryant Ranch Prepack, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-05-10
- **Report date:** 2024-06-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Burbank, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0540-2024

## Citation

> AI Analytics. FDA recall D-0540-2024. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/D-0540-2024. Source: US FDA. Licensed CC0.

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