vancomycin HCl, 2 grams, 2 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Ste...

FDA Recall #D-0337-2026 — Class II — February 5, 2026

Recall #D-0337-2026 Date: February 5, 2026 Classification: Class II Status: Ongoing

Product Description

vancomycin HCl, 2 grams, 2 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-019-59.

Reason for Recall

Lack of Assurance of Sterility

Recalling Firm

Fresenius Kabi Compounding, LLC — Canton, MA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

N/A

Distribution

US Nationwide.

Code Information

Lot # C274-000047611, Exp Date: 10-Feb-26; Lot # C274-000049633, Exp Date: 12-May-26.

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated