The Recall Desk
ModerateFDA (Drugs)·D-0018-2025·Announced 2024-10-30

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
Hazard
  • manufacturing-defect
  • potential-contamination

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.

Related recalls

Same category