FDA Recalls NORepinephrine Injection Due to Manufacturing Violations
Fresenius Kabi Compounding is recalling NORepinephrine Bitartrate injection due to manufacturing violations. The affected medication was distributed to 125 accounts nationwide. Healthcare providers using this product should contact their supplier.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Class II recall of an injectable medication with manufacturing violations. Manufacturing defects in injectables represent a risk-of-harm scenario; however, no illnesses or injuries have been reported.
Plain-English summary
Fresenius Kabi Compounding, LLC is recalling NORepinephrine Bitartrate 0.9% Sodium Chloride Injection, 8 mg per 250 mL, in single-dose bags. The affected lot is #C274-000038404, with an expiration date of November 18, 2024. The FDA classifies this as a Class II recall.
The recall was initiated due to manufacturing process violations. Fresenius Kabi Compounding voluntarily initiated the recall on September 25, 2024, and healthcare providers were notified by letter. The FDA issued the official recall classification on October 21, 2024.
The medication was distributed to 125 direct accounts nationwide. Approximately 733 single-dose bags are affected. This is a prescription injectable medication used in hospitals and clinical settings.
Healthcare providers using the affected lot should stop administering it and contact Fresenius Kabi Compounding directly. Patients should not discontinue prescribed medications without consulting their healthcare provider. The recall was terminated on August 15, 2025.
The recalled product
- Product
- NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-027-58
- Manufacturer
- Fresenius Kabi Compounding, LLC
- Category
- Drug — Injectable medication
- Hazard
- manufacturing-violation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # C274-000038404
- exp. date 18-Nov-24
Distribution
Distributed nationwide across the United States.
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