Warning
Fresenius Kabi Compounding Recalls vancomycin HCl
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0336-2026Drug / Pharmaceutical
Fresenius Kabi Compounding Recalls vancomycin HCl
Fresenius Kabi Compounding, LLC · Class II — Moderate Risk
Product Description
vancomycin HCl, 1.5 grams, 1.5 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-016-59
Reason for Recall
Lack of Assurance of Sterility
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
US Nationwide.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
The FDA classified this recall as Class II, indicating the pharmaceutical product may cause temporary health problems or poses a slight threat of a serious nature. Fresenius Kabi Compounding, LLC initiated the recall on February 5, 2026 affecting 1578 bags. Lack of Assurance of Sterility. The product was distributed in US Nationwide. Consumers should check their purchases and discontinue use of any affected product. Contact Fresenius Kabi Compounding, LLC for further instructions.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medication Defects.