Recall Ledger

Vancomycin Injection recall (Baxter Healthcare Corporation)

DrugClass IIOngoing

Summary: Baxter Healthcare Corporation is recalling Vancomycin Injection, USP in 5% Dextrose, 1 g per 200mL (5 mg/mL), in GALAXY Single-Dose Container, Rx only, Sterile Nonpyrogenic, Iso-osmotic, Baxter Healthcare Corporation, Deerfield, IL, 60015 USA, NDC 0338-3552-48.. Reason: CGMP Deviations.

What is being recalled

Vancomycin Injection, USP in 5% Dextrose, 1 g per 200mL (5 mg/mL), in GALAXY Single-Dose Container, Rx only, Sterile Nonpyrogenic, Iso-osmotic, Baxter Healthcare Corporation, Deerfield, IL, 60015 USA, NDC 0338-3552-48.

Why

CGMP Deviations

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

US Nationwide; Puerto Rico; and Chile. (states named: Puerto Rico)

How to tell if yours is affected

Lot # NC188678, Exp Date: 12/1/2026; Lot # NC188814, Exp Date: 12/5/2026; Lot # NC188944, Exp Date: 12/8/2026; Lot # NC193610, Exp Date: 4/21/2027, Lot # NC193665, Exp Date: 4/23/2027.

What to do

Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.

Recall facts

Recall numberD-0805-2026
CategoryDrug
AgencyU.S. Food and Drug Administration (FDA)
SeverityClass II
StatusOngoing
Recall startedAugust 6, 2026
ReportedSeptember 9, 2026
CompanyBaxter Healthcare Corporation
Company locationDeerfield, IL, United States
Initiated byVoluntary: Firm initiated
QuantityN/A

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Official FDA record