Quick Facts at a Glance
- Recall Date
- August 5, 2025
- Hazard Level
- HIGH
- Brands
- ENOXAPARIN SODIUM, Cardinal Health 107, LLC, Sandoz Inc
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, PREGNANT
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- ENOXAPARIN SODIUM, Cardinal Health 107, LLC, Sandoz Inc
- Product type
- Enoxaparin Sodium Injection
- Model numbers
- Outer package - NDC 55154-3543-5, Inner label - NDC 0781-3238-01, Lot SAD08033AA, Lot SAF13211A
- UPC codes
- 55154-3540, 55154-3541, 55154-3542, 55154-3543, 55154-3544, 0781-3238, 0781-3246, 0781-3256 +12 more
- Sizes
- 0.3 mL
- Sold at
- Unknown
- Where affected
- KS
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 5, 2025
Reported by FDA DRUG
September 3, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Cardinal Health Inc. or your healthcare provider for guidance. Notification method: Letter
About This Product
Enoxaparin Sodium Injection is an anticoagulant used to prevent and treat deep vein thrombosis and pulmonary embolism. It is administered by healthcare professionals.
Why This Is Dangerous
Mislabeled bags could result in incorrect dosing, potentially causing under-anticoagulation or over-anticoagulation with risk of bleeding.
Industry Context
This recall is not stated as part of a broader industry pattern.
Real-World Impact
Immediate action required for clinicians and patients using affected lots; risk to patient safety if incorrect dose is administered.
Practical Guidance
How to identify if yours is affected
- Verify outer label NDC 55154-3543-5.
- Verify inner label NDC 0781-3238-01.
- Check Lot numbers SAD08033AA or SAF13211A.
Where to find product info
FDA enforcement page for D-0597-2025; recall letters from Cardinal Health and Sandoz.
What timeline to expect
Refund/replacement processes follow agency guidance in recall letters; timeline varies by institution.
If the manufacturer is unresponsive
- Escalate to hospital risk management
- File a complaint with FDA if provider unresponsive
How to prevent similar issues
- Always verify NDCs before administration
- Use serials to track lots
- Follow hospital protocol for drug recalls
Documentation advice
Keep recall letter, log lot numbers, capture communications with supplier and pharmacy
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Product Details
Product: Enoxaparin Sodium Injection, USP, 30 mg/0.3 mL. Packaging: 0.3 mL prefilled syringes in bags of 5. Outer label NDC 55154-3543-5. Inner label NDC 0781-3238-01. Distributor: Cardinal Health Inc. and Sandoz Inc. Route: Rx Only.
Reported Incidents
No injuries or incidents have been reported in the recall notice.
Key Facts
- 20 bags affected? (quantity field indicates 10 bags in description)
- High hazard due to dosing mislabeling
- Lot numbers: SAD08033AA, SAF13211A
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Safety Guide
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