Baxter Vancomycin Hydrochloride Injection Recall Over CGMP Deviations (Aug 6, 2026)
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Baxter Healthcare Corporation is recalling specific lots of Vancomycin Injection, USP in 5% Dextrose due to CGMP deviations.
FDA recall: what the record actually shows
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.
The original agency source is linked below so you can verify this record directly before acting on it. Its related labels are recall, product-safety, fda, Drugs.
What Happened
Baxter Healthcare Corporation initiated a voluntary recall of Vancomycin Hydrochloride Injection due to CGMP Deviations. The recall is classified as Class II.
Which Products Are Affected
Vancomycin Injection, USP in 5% Dextrose, 1 g per 200mL (5 mg/mL), in GALAXY Single-Dose Container, Rx only, Sterile Nonpyrogenic, Iso-osmotic. NDC 0338-3552-48. Affected lots include: 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. Distributed to US Nationwide, Puerto Rico, and Chile.
What You Should Do
Consumers should refer to the recalling firm for further guidance on the affected product.
Why This Matters
This Class II recall involves a product distributed across the United States, Puerto Rico, and Chile.
Source
FDA recall number D-0805-2026, Baxter Healthcare Corporation.
Original source: FDA Official Notice ↗
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Nationwide notices with similar length or severity timing 8
Beyond this FDA recall's own category, Areazine surfaces two nationwide peer sets: length-matched and severity/date-matched notices from elsewhere in the archive, distinct from the same-feed Related list above.
Similar body length
Nearest notices by article body length (941 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to September 14, 2026.
Questions & Answers
Questions readers often have about this FDA recall.