Class IIOngoing

Enoxaparin Sodium Injection recall

FDA recall D-0597-2025 · initiated Aug 5, 2025

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

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

Details

Product: 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
Recalling company: Cardinal Health Inc.
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: KS
Initiated: Aug 5, 2025
FDA report date: Sep 3, 2025

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0597-2025 ↗

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