Baxter Daptomycin in Sodium Chloride 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 one lot of Daptomycin 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.

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

Daptomycin, in 0.9% Sodium Chloride Injection, 1,000 mg per 100 mL (10 mg/mL), 1,000 mg total, in 1000 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0718-12. Lot # NC193856, Exp Date: 04/18/2028. Distributed to US Nationwide; Puerto Rico; and Chile. Recall number D-0821-2026.

What You Should Do

Consumers with questions should contact the recalling firm or their healthcare provider.

Why This Matters

This Class II recall involves a human prescription drug distributed nationwide.

Source

FDA recall D-0821-2026

Original source: FDA Official Notice ↗

All FDA Recalls →

Similar notices nationwide by 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.

What People Ask

Common questions about this FDA recall.

What is this FDA recall about?
Baxter Healthcare Corporation is recalling one lot of Daptomycin 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.