Vancomycin Injection Recalled Due to Manufacturing Process Violations
Fresenius Kabi Compounding is recalling Vancomycin HCl injectable medication due to cGMP manufacturing violations. The recall affects 1,082 bags distributed to 125 healthcare accounts nationwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II voluntary precautionary recall due to manufacturing process violations with no reported illnesses or injuries, appropriately scored as Moderate severity.
Plain-English summary
Fresenius Kabi Compounding, LLC is recalling Vancomycin HCl 750 mg per 250 mL 0.9% Sodium Chloride Injection in single-dose bags (NDC 71506-014-58) due to cGMP violations in the manufacturing process.
The product was distributed to 125 direct accounts nationwide. A total of 1,082 bags were distributed under lot number C274-000038004, with expiration date November 27, 2024.
Healthcare providers should immediately cease use of this product and contact Fresenius Kabi Compounding to arrange its return. The recall was initiated September 25, 2024 and concluded August 15, 2025.
The recalled product
- Product
- Vancomycin HCl 750 mg per 250 mL 0.9% Sodium Chloride Injection USP, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-014-58
- Manufacturer
- Fresenius Kabi Compounding, LLC
- Category
- Drug
- Affected units
- 1,082
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 # C274-000038004
- exp. date 27-Nov-24
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 recalled by Fresenius Kabi Compounding, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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