Baxter Vancomycin Hydrochloride Injection Recall Over CGMP Deviations
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Baxter Healthcare Corporation is recalling one lot of Vancomycin Injection, USP due to CGMP deviations.
Reading this FDA recall beyond the headline
This notice was issued by FDA on September 14, 2026 and geographically references United States. The FDA classifies this as a Class II recall, with the stated reason "CGMP Deviations", distributed us nationwide; puerto rico; and chile.. FDA recall classes run from I (reasonable probability of serious harm) to III (unlikely to cause harm), so the class number is the fastest way to gauge severity here. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
A quick skim tells you whether this affects you directly; a closer read tells you more. Check the scope, the source, and how recent the record is, then weigh it against related notices rather than treating any single one as a trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, drugs.
What Happened
Baxter Healthcare Corporation initiated a voluntary recall due to CGMP deviations.
Which Products Are Affected
Vancomycin Injection, USP, in 0.9% Sodium Chloride, 1g per 200 mL (5 mg/mL) in GALAXY Single-Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL, 60015 USA, NDC 0338-3583-01. Lot # NC193894, Exp Date: 04/25/2027. Distributed nationwide in the US, Puerto Rico, and Chile.
What You Should Do
The recall was initiated voluntarily by the firm via letter.
Why This Matters
This is an ongoing Class II recall affecting a human prescription drug.
Source
FDA recall number D-0820-2026, report date 20260909.
Original source: FDA Official Notice ↗
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Comparable nationwide notices (length or severity timing) 8
Two cross-category peer sets, both computed from Areazine's own archive: notices with a similar body length, and notices near the same severity and agency date. These are drawn from other categories, not the same-feed Related list above.
Similar body length
Nearest notices by article body length (683 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to September 14, 2026.
Common Questions
Questions readers often have about this FDA recall.