Agency classClass IIOur severity:Severe FDA (Drugs)·D-0820-2026·Announced 2026-09-09

Baxter Recalls Vancomycin Injection Due to CGMP Deviations

Baxter Healthcare is voluntarily recalling specific lots of Vancomycin Injection due to Current Good Manufacturing Practice (CGMP) deviations.

The agency’s classification

FDA (Drugs): Class II

Class II is 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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text explicitly states the FDA classification is Class II. According to the severity rubric, an FDA Class II recall corresponds to a score of 4 (Severe), particularly given the nature of the product and the CGMP deviations involved.

Plain-English summary

Baxter Healthcare Corporation is voluntarily recalling Vancomycin Injection, USP, in 0.9% Sodium Chloride, 1g per 200 mL (5 mg/mL) in GALAXY Single-Dose Container. The recall affects Lot # NC193894 with an expiration date of 04/25/2027. The product is identified by NDC 0338-3583-01.

The recall was initiated by the firm on August 6, 2026, due to Current Good Manufacturing Practice (CGMP) deviations. The FDA has classified this recall as Class II, which indicates a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

The affected product was distributed nationwide in the United States, as well as in Puerto Rico and Chile. Healthcare providers and patients should discontinue use of the affected lot and contact their pharmacist or Baxter Healthcare for further instructions.

The recalled product

Product: VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN HYDROCHLORIDE)
Brand: VANCOMYCIN HYDROCHLORIDE
Manufacturer: Baxter Healthcare Corporation
Category: Drug — Antibiotic Injection
Hazard: cgmp-deviation
contamination-risk

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 # NC193894
Exp Date: 04/25/2027.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same brand · VANCOMYCIN HYDROCHLORIDE

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