# FDA recall D-0569-2025

> **Sandoz Inc** · Class I · drug recall initiated 2025-06-27.

## Product

Cefazolin for Injection, USP, 1 gram per vial, Sterile, For Intramuscular or Intravenous Use, Rx Only, Manufactured by Sandoz GmbH for Sandoz Inc. Princeton, NJ 08540, NDC: 0781 3451-70 (vial), NDC: 0781-3451-96 (carton).

## Reason for recall

Labeling: Label Mix-Up; cartons of Cefazolin for Injection, USP 1 gram were found to contain vials labeled as penicillin G potassium for Injection, USP, 20 million Unit. The vials contained Cefozalin

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0569-2025
- **Recalling firm:** Sandoz Inc
- **Classification:** Class I
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-06-27
- **Report date:** 2025-07-09

- **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-0569-2025

## Citation

> AI Analytics. FDA recall D-0569-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0569-2025. Source: US FDA. Licensed CC0.

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