Baxter Recalls Vancomycin Injection Due to Manufacturing 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, which indicates a situation that could cause temporary or medically reversible adverse health consequences. The hazard is a manufacturing deviation (CGMP) in a sterile injectable drug, which poses a risk of harm, but no specific illnesses or injuries are reported in the source text.
Plain-English summary
Baxter Healthcare Corporation is voluntarily recalling specific lots of Vancomycin Injection, USP in 5% Dextrose, 1 g per 200mL (5 mg/mL), in GALAXY Single-Dose Container. The recall was initiated on August 6, 2026, and is classified as Class II by the FDA. The reason for the recall is Current Good Manufacturing Practice (CGMP) deviations.
The affected product is a prescription-only sterile, nonpyrogenic, iso-osmotic injection. The specific lots subject to recall are NC188678, NC188814, NC188944, NC193610, and NC193665. These lots have expiration dates ranging from December 1, 2026, to April 23, 2027.
The product was distributed nationwide in the United States, as well as in Puerto Rico and Chile. Healthcare providers and patients should check their inventory and records for these specific lot numbers. If the product is found, it should be quarantined and returned to the distributor or manufacturer according to standard recall procedures.
The recalled product
- Product
- VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN HYDROCHLORIDE)
- Brand
- VANCOMYCIN HYDROCHLORIDE
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Drug — Antibiotic Injection
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 (10)
- 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.
Distribution
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