Fresenius Kabi Compounding Recalls Ketamine HCl Injection Over Sterility Concerns
According to the U.S. Census Bureau's American Community Survey (ACS) 5-year estimates, the CDC PLACES population-level health analysis, and the CMS Hospital Compare quality data, Areazine publishes editorial articles drawing on more than 19,000 U.S. city profiles. See our methodology for full source attribution and refresh cadence.
Fresenius Kabi Compounding, LLC has voluntarily recalled 1,410 bags of Ketamine HCl in Sodium Chloride Injection due to a lack of assurance of sterility.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on February 24, 2026 and geographically references United States. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — FDA Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who 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 read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, fda, Drugs) map to related alerts in the same area of risk — browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.
What Happened
Fresenius Kabi Compounding, LLC has initiated a voluntary recall of Ketamine HCl in Sodium Chloride Injection. The recall was triggered due to a lack of assurance of sterility for the affected products. The FDA has classified this as a Class II recall, which was officially reported on February 18, 2026.
Which Products Are Affected
The recall involves 1,410 bags of ketamine HCl, 1,000 mg per 100 mL (10 mg per mL) in Sodium Chloride Injection. The products are labeled under Fagron Sterile Services with NDC 71506-050-56.
The following lot numbers and expiration dates are included in this recall:
- Lot # C274-000047883 (Exp Date: 17-Feb-26)
- Lot # C274-000048515 (Exp Date: 22-Mar-26)
- Lot # C274-000048679 (Exp Date: 31-Mar-26)
- Lot # C274-000049119 (Exp Date: 19-Apr-26)
- Lot # C274-000049282 (Exp Date: 27-Apr-26)
What You Should Do
Healthcare providers and facilities should immediately check their inventory for the affected lot numbers. Any products from these lots should be quarantined and not administered to patients. The firm began notifying customers via letter on February 5, 2026. For information regarding the return process, contact Fresenius Kabi Compounding, LLC at their Canton, MA location.
Why This Matters
A lack of assurance of sterility in injectable medications is a serious safety concern, as it increases the risk of patients developing life-threatening infections or other adverse medical complications upon administration.
Source
Recall information provided by the FDA under Recall Number D-0334-2026.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Frequently Asked Questions
Common questions about this FDA recall.
What is this FDA recall about? ▾
Which agency issued this alert? ▾
How severe is this alert? ▾
What area is affected? ▾
Where can I find more FDA Recalls updates? ▾
Primary source data
EPA Outdoor Air Quality Data
Federal monitoring network — every measurement we report
AirNow (EPA / NOAA)
Real-time AQI for every monitored U.S. location
National Weather Service
Active watches, warnings, and advisories — NOAA
CDC Air Quality & Health
Health-impact reference behind every AQI category