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Drug FDA Class II Ongoing Mislabeling

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

Cardinal Health Inc. Published Sep 3, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 50/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Cardinal Health Inc. or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL

Affected products (1)

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

ENOXAPARIN SODIUM · 10 bags

NDC: 55154-3540, 55154-3541, 55154-3542, 55154-3543, 55154-3544, 0781-3238, 0781-3246, 0781-3256, 0781-3262, 0781-3268, 0781-3298, 0781-3299, 55154-3540-5, 55154-3541-5, 55154-3542-5, 55154-3543-5, 55154-3544-5, 0781-3238-01, 0781-3238-63, 0781-3246-02, 0781-3246-64, 0781-3256-03, 0781-3256-66, 0781-3262-04, 0781-3262-68, 0781-3268-05, 0781-3268-69, 0781-3298-04, 0781-3298-68, 0781-3299-05, 0781-3299-69
Lot codes: AD08033AA, AF13211A
Code info: Outer package - NDC 55154-3543-5, Lot SAD08033AA Inner label - NDC 0781-3238-01, Lot SAF13211A

Affected areas

Kansas

Timeline

  1. Initiated
    Aug 5, 2025
  2. Published
    Sep 3, 2025
Recall number
D-0597-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.