Fresenius Kabi Compounding Recalls Vancomycin HCl Injection Due to Sterility Concerns
Fresenius Kabi Compounding, LLC has issued a voluntary nationwide recall for 1,578 bags of Vancomycin HCl injection over concerns regarding a lack of assurance of sterility.
What Happened
Fresenius Kabi Compounding, LLC, operating as Fagron Sterile Services in Canton, MA, has initiated a voluntary recall of Vancomycin HCl injection products. The recall was triggered due to a lack of assurance of sterility, which poses a potential risk to patient safety. The FDA classified this as a Class II recall on February 13, 2026, following the firm’s initial notification on February 5, 2026.
Which Products Are Affected
The recall affects 1,578 bags of the following medication distributed nationwide across the United States:
- Product Name: vancomycin HCl, 1.5 grams, 1.5 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP
- NDC: 71506-016-59
- Lot Number: C274-000049628
- Expiration Date: 3-May-26
- Manufacturer/Labeler: Fagron Sterile Services / Fresenius Kabi Compounding, LLC
What You Should Do
Healthcare providers and facilities should immediately examine their stock to identify and quarantine the affected lot. Fresenius Kabi Compounding, LLC has initiated notification to customers via letter. For further information regarding the return process or clinical concerns, stakeholders can contact the firm at their facility located at 20 Dan Rd, Canton, MA 02021.
Why This Matters
Injectable medications that lack assurance of sterility present a significant health hazard, as they can introduce contaminants directly into a patient’s bloodstream, potentially leading to serious infections or life-threatening complications.
Source
This report is based on official recall data provided by the FDA under Recall Number D-0336-2026.
Source: FDA Official Notice