Medications & Supplements/Prescription Drugs

Sandoz Enoxaparin Sodium Injection Recalled for Strength Mislabeling

Agency Publication Date: August 22, 2025

Summary

Cardinal Health Inc. is recalling 10 bags of Sandoz Enoxaparin Sodium Injection (enoxaparin sodium) because of a labeling error. The bags are labeled as containing 80 mg/0.8 mL doses, but they actually contain 30 mg/0.3 mL doses. This mistake means a patient would receive less than half of the intended medication dose, which was distributed in Kansas.

Risk

If a patient receives a 30 mg dose instead of the prescribed 80 mg dose, the medication will not be effective at preventing or treating dangerous blood clots. This could lead to serious medical complications from untreated clotting issues.

What You Should Do

This recall involves bags of Sandoz Enoxaparin Sodium Injection, USP, that are labeled as 80 mg/0.8 mL but contain 30 mg/0.3 mL prefilled syringes. Affected outer packages have NDC 55154-3543-5 with Lot SAD08033AA; inner syringe labels have NDC 0781-3238-01 with Lot SAF13211A.
If you have health concerns or believe you may have received an incorrect dose of this medication, contact your healthcare provider or pharmacist immediately.
Return any unused product to the place of purchase for a refund, throw it away, or contact Cardinal Health Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Enoxaparin Sodium Injection, USP (30 mg/0.3 mL)by Sandoz

Variants: 30 mg/0.3 mL, Injection

Lot Numbers:

SAD08033AA

SAF13211A

NDC:

55154-3543-5

0781-3238-01

Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, incorrectly contained Enoxaparin Sodium Injection, 30 mg/0.3 mL syringes.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97380

Status: Active

Manufacturer: Cardinal Health Inc.

Sold By: Pharmacies; Hospitals

Manufactured In: United States

Units Affected: 10 bags

Distributed To: Kansas

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall involves bags of Sandoz Enoxaparin Sodium Injection, USP, that are labeled as 80 mg/0.8 mL but contain 30 mg/0.3 mL prefilled syringes. Affected outer packages have NDC 55154-3543-5 with Lot SAD08033AA; inner syringe labels have NDC 0781-3238-01 with Lot SAF13211A.

If you have health concerns or believe you may have received an incorrect dose of this medication, contact your healthcare provider or pharmacist immediately.

Return any unused product to the place of purchase for a refund, throw it away, or contact Cardinal Health Inc. for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.