---
title: "Enoxaparin Sodium Injection, USP, 30 mg/0.3 mL, packaged in 0.3 mL prefilled ... — FDA record D-0597-2025 | Is It on Recall"
description: "Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL"
url: https://isitonrecall.com/recall/fda-drug-d-0597-2025-enoxaparin-sodium-injection-usp-30-mg-0-3-ml-packaged-in-0-3-ml-prefilled-syringes-further-packaged/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA drug enforcement

# Enoxaparin Sodium Injection, USP, 30 mg/0.3 mL, packaged in 0.3 mL prefilled syringes further packaged in bags of 5 p... — FDA record D-0597-2025

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Aug 5, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **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**: Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL
- **Classification**: Class II
- **Recalling firm**: Cardinal Health Inc.
- **Quantity**: 10 bags
- **Agency-reported status**: Ongoing
- **Source record identifier**: D-0597-2025

[Open the official record](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0597-2025%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Outer package - NDC 55154-3543-5, Lot SAD08033AA Inner label - NDC 0781-3238-01, Lot SAF13211A |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

KS

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Kansas](https://isitonrecall.com/state/kansas/)

## Dates in the source

- **Report date**: Sep 3, 2025
- **Recall initiation date**: Aug 5, 2025
- **Center classification date**: Aug 22, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0597-2025%22)

## Before changing a medicine

Follow urgent instructions in the current official recall notice. Speak to your pharmacist or prescriber before stopping or changing a prescribed medicine.

Talk to your doctor or pharmacist if you have questions or concerns about your medicine. [FDA medication recall guidance](https://www.fda.gov/drugs/drug-recalls/understanding-drug-recalls-what-know-and-what-do)

## Related records

[Medications records](https://isitonrecall.com/category/medications/) [Cardinal Health Inc. records](https://isitonrecall.com/brand/cardinal-health-inc/)