Cardinal Health recalls Enoxaparin Sodium Injection 30mg/0.3mL prefilled syringes packaged in bags of 5 due to mislabeled product. The bags intended for 80mg/0.8mL contain 30mg/0.3mL instead.
Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL
Cardinal Health is recalling Enoxaparin Sodium Injection 30 mg/0.3 mL prefilled syringes that were packaged in bags of 5. The recall happens because the bags labeled for 80 mg/0.8 mL contain the smaller 30 mg/0.3 mL product instead. This could lead to incorrect dosing if the product is used without checking the label.
The recalled product was mislabeled in the packaging. Bags intended for 80 mg/0.8 mL injections contain 30 mg/0.3 mL injections instead. This could lead to incorrect dosing if the product is used without verifying the label.
Patients prescribed Enoxaparin Sodium Injection for blood thinning who received the recalled product. Healthcare providers using the product for medical treatments are also affected.
Check for bags labeled 'Enoxaparin Sodium Injection, 80 mg/0.8 mL' that contain 30 mg/0.3 mL syringes. The product has NDC 55154-3543-5 on the outer package and NDC 0781-3238-01 on the inner label.
Verify the product label on the syringe and outer packaging to ensure it matches the intended 80 mg/0.8 mL dose.
The recall is due to mislabeled product where bags intended for 80 mg/0.8 mL contain 30 mg/0.3 mL injections instead.
Check for bags labeled 'Enoxaparin Sodium Injection, 80 mg/0.8 mL' that contain 30 mg/0.3 mL syringes. The product has NDC 55154-3543-5 on the outer package and NDC 0781-3238-01 on the inner label.
The official recall notice does not specify a remedy or action for the product. Check the product label to ensure it matches the intended dose before use.
We’ve drafted a message you can send Cardinal Health to request your refund or repair — edit it as you like.
Subject: Recall D-0597-2025 — Cardinal Health Cardinal Health Hello, I own a Cardinal Health that is covered by recall D-0597-2025 from Cardinal Health. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.