Sandoz Inc. recalled 10 bags of Enoxaparin Sodium Injection on August 5, 2025. Bags labeled for Enoxaparin Sodium 80 mg/0.8 mL contained the incorrect dosage of 30 mg/0.3 mL. Consumers and healthcare providers must stop using the product immediately.
Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL
Consumers and healthcare providers should stop using this product immediately. Contact Cardinal Health Inc. or your healthcare provider for guidance. Notification method: Letter
The recall involves Enoxaparin Sodium Injection, USP, 30 mg/0.3 mL, packaged in bags of 5 prefilled syringes. The outer package has NDC 55154-3543-5 and the inner label NDC 0781-3238-01. The product was distributed in Kansas.
The mispackaged product could lead to serious health risks if administered in the incorrect dosage. Enoxaparin Sodium is an anticoagulant, and improper dosing may cause adverse effects.
No specific incidents or injuries have been reported in connection with this recall. The classification of this recall is Class II, indicating a potential risk.
Stop using the product immediately. Contact Cardinal Health Inc. or consult your healthcare provider for further guidance.
For more information, visit the FDA recall page or call Cardinal Health Inc. at 1-800-XXXX-XXXX for assistance.
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