ENOXAPARIN SODIUM
Recalling Firm / Manufacturer: Cardinal Health Inc.
(Dublin, OH, United States)
FDA Recall Number: D-0597-2025
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
ENOXAPARIN SODIUM
Generic Name
ENOXAPARIN SODIUM
Active Substance(s)
Enoxaparin Sodium
Administration Route
Subcutaneous
National Drug Code (NDC)
55154-3540
Total Quantity Recalled
10 bags
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL
Full Product Description
Packaging specifications and labeling details
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
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class II
Current Action Status
Ongoing
FDA Enforcement Report Date
September 03, 2025
Firm Initiation Date
August 05, 2025
FDA Classification Date
Aug 22, 2025
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Outer package - NDC 55154-3543-5, Lot SAD08033AA Inner label - NDC 0781-3238-01, Lot SAF13211A
Distribution Information
Geographic scope of affected shipments
KS
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Patient Advisory
Check your prescription bottle or packaging against the affected lot numbers listed above. If your medication matches a recalled lot, contact your pharmacist for replacement guidance.
Healthcare Provider Guidance
Audit pharmacy stock and return affected lots to the distributor per manufacturer instructions. Notify patients where clinically indicated.
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0597-2025
Questo Retrieval Date: July 31, 2026 14:36 1785508613UTCC