Enoxaparin Sodium Injection
FDA Recall NDC 0781-3299
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Enoxaparin Sodium (NDC 0781-3299). A significant event, classified as Class II, was initiated on Aug 05, 2025 by Sandoz Inc. The reported reason for this action was: "Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL
Aug 05, 2025
Sep 03, 2025
10 bags
Recall Profile & Regulatory Data
Event ID
97380
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Cardinal Health Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
KS
Product Description
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
Batch or Lot Expiration Information
Lot# Outer package - NDC 55154-3543-5, Lot SAD08033AA Inner label - NDC 0781-3238-01, Lot SAF13211A
Affected Packages Involved in this Recall
55154-3540-5Product
55154-3541-5Product
55154-3542-5Product
55154-3543-5Product
55154-3544-5Product
0781-3238-01Product
0781-3238-63Product
0781-3246-02Product
0781-3246-64Product
0781-3256-03Product
0781-3256-66Product
0781-3262-04Product
0781-3262-68Product
0781-3268-05Product
0781-3268-69Product
0781-3298-04Product
0781-3298-68Product
0781-3299-05Product
0781-3299-69Product
Class II Terminated
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Jan 26, 2022
Jan 03, 2024
2 units
Recall Profile & Regulatory Data
Event ID
89450
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
CARDINAL HEALTHCARE
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide USA
Termination Date
Sep 29, 2024
Product Description
Enoxaparin Sodium Injection, USP, 150MG/ML Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Injection, Ten 1 mL Syringes per box, Rx Only, Sandoz Inc, Princeton, NJ 08540. NDC: 0781-3299-69
Batch or Lot Expiration Information
Batch# Batch SAH06821A
Affected Packages Involved in this Recall
0781-3238-01Product
0781-3238-63Product
0781-3246-02Product
0781-3246-64Product
0781-3256-03Product
0781-3256-66Product
0781-3262-04Product
0781-3262-68Product
0781-3268-05Product
0781-3268-69Product
0781-3298-04Product
0781-3298-68Product
0781-3299-05Product
0781-3299-69Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
