Enoxaparin Sodium Injection recall
FDA recall D-0597-2025 · initiated Aug 5, 2025
Cardinal Health Inc. recalled Enoxaparin Sodium Injection in Aug 2025 — an FDA Class II recall (D-0597-2025) because Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL.
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
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 10 bags
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
Frequently asked
- Was Enoxaparin Sodium Injection recalled?
- Cardinal Health Inc. recalled Enoxaparin Sodium Injection in Aug 2025 — an FDA Class II recall (D-0597-2025) because Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Enoxaparin Sodium Injection recalled?
- Per the FDA enforcement record, the reason for recall D-0597-2025 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
- Is a recalled Enoxaparin Sodium Injection dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Enoxaparin Sodium Injection are affected?
- Distributed: KS. The recall covers these lots — Outer package - NDC 55154-3543-5, Lot SAD08033AA Inner label - NDC 0781-3238-01, Lot SAF13211A. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0597-2025.