# FDA recall D-0651-2025

> **Sandoz Inc** · Class II · drug recall initiated 2025-09-05.

## Product

Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL), Hazardous Drug, Rx Only, Sterile, 5mL Multiple Dose Vial, Manufactured in Austria by Fareva Unterach GmbH for Sandoz Inc., Princeton, NJ 08540, Product of India, Vial NDC# 0781-3528-75, Carton NDC# 0781-3528-10.

## Reason for recall

cGMP deviations: Temperature excursion during transportation.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0651-2025
- **Recalling firm:** Sandoz Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-09-05
- **Report date:** 2025-09-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Princeton, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0651-2025

## Citation

> AI Analytics. FDA recall D-0651-2025. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/D-0651-2025. Source: US FDA. Licensed CC0.

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