Baxter Clindamycin Injection Recall Over CGMP Deviations (Aug 6, 2026)
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 two lots of Clindamycin Injection USP in 5% Dextrose 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.
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 of Clindamycin Injection USP in 5% Dextrose due to CGMP Deviations.
Which Products Are Affected
Clindamycin Injection USP in 5% Dextrose, 600 mg per 50 mL (12 mg/mL) in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-3612-50. Affected lots are Lot # NC193764 (Exp Date: 10/18/2027) and Lot # NC195232 (Exp Date: 11/25/2027). The recall covers distribution to US Nationwide, Puerto Rico, and Chile.
What You Should Do
This is a voluntary firm-initiated recall classified as Class II by the FDA.
Why This Matters
The recall involves a human prescription drug distributed across multiple regions due to manufacturing practice deviations.
Source
FDA recall number D-0808-2026
Original source: FDA Official Notice ↗
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Comparable nationwide notices (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.
Similar body length
Nearest notices by article body length (847 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to September 14, 2026.
What People Ask
Common questions about this FDA recall.