# FDA recall D-0597-2025

> **Cardinal Health Inc.** · Class II · drug recall initiated 2025-08-05.

## Product

Enoxaparin Sodium Injection, USP, 30 mg/0.3 mL, packaged in 0.3 mL prefilled syringes further packaged in bags of 5 prefilled syringes, Rx Only, Dist. by: Sandoz Inc., Princeton, NJ 08540, Outer package - NDC 55154-3543-5, Inner label - NDC 0781-3238-01

## Reason for recall

Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL

## Distribution

KS

## Key facts

- **Recall number:** D-0597-2025
- **Recalling firm:** Cardinal Health Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-08-05
- **Report date:** 2025-09-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Dublin, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0597-2025

## Citation

> AI Analytics. FDA recall D-0597-2025. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/D-0597-2025. Source: US FDA. Licensed CC0.

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