Baxter Vasopressin in 0.9% Sodium Chloride Injection Recall Over CGMP Deviations

Source: FDA · United States

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 specific lots of Vasopressin in 0.9% Sodium Chloride Injection due to CGMP deviations.

The full picture behind this FDA recall

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.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.

Before acting, the primary agency source is available to check alongside this summary. 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

Vasopressin, in 0.9% Sodium Chloride Injection, 40 units per 100 mL (0.4 units/mL), 100mL Single-Dose Container, Rx only, Sterile, Baxter Healthcare Corporation, Deerfield, IL, 60015 USA, NDC 0338-9647-12. Affected lots: Lot # NC185448 (Exp Date: 8/31/2027); Lot # NC192910 (Exp Date: 4/30/2028); Lot # NC195218 (Exp Date: 6/30/2028). Distributed nationwide in the US, Puerto Rico, and Chile. Recall number D-0819-2026. Classification: Class II. Status: Ongoing.

What You Should Do

Contact the recalling firm for further information on the voluntary recall.

Why This Matters

This Class II recall involves a human prescription drug distributed across the United States and internationally.

Source

FDA recall number D-0819-2026; event_id 99500.

Original source: FDA Official Notice ↗

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Elsewhere in the country: similar length or severity timing 8

Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.

Common Questions

Common questions about this FDA recall.

What is this FDA recall about?
Baxter Healthcare Corporation is recalling specific lots of Vasopressin in 0.9% Sodium Chloride Injection due to CGMP deviations.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How is this recall classified, and why does that matter?
The FDA classifies this as a Class II recall, citing "CGMP Deviations" as the reason. Class I is the most serious (reasonable probability of serious harm), Class II is a moderate or temporary health risk, and Class III is unlikely to cause harm.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.