Baxter Famotidine 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 two lots of Famotidine Injection in Sodium Chloride due to CGMP deviations.
What this FDA recall tells you, and what most readers miss
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 due to CGMP Deviations.
Which Products Are Affected
Famotidine Injection in Sodium Chloride Injection, 20 mg, 50 mL in GALAXY Single Dose Container, Rx Only, Sterile Nonpyrogenic, NDC 0338-5197-41. Affected lots are NC188586 (Exp Date: 02/28/2027) and NC188913 (Exp Date: 3/9/2027). 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 is an ongoing Class II recall of a prescription intravenous drug distributed across multiple regions.
Source
FDA recall number D-0809-2026, Baxter Healthcare Corporation, Deerfield, IL.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Medline Convenience Kits Recall Over ChloraPrep Applicator Sterility Breach (Ref. 2fe0d4)
FDA · September 16, 2026
Cardinal Health Presource Packs Recall Over CliniClean Pericare Wipes Contamination (Ref. 1adab6)
FDA · September 16, 2026
Medline Convenience Kits Recall Over BD ChloraPrep Applicator Seal Issue (Ref. 929d71)
FDA · September 16, 2026
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 (746 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to September 14, 2026.
Frequently Asked Questions
Questions readers often have about this FDA recall.