Fresenius Kabi Compounding Recalls Ketamine HCl Injection Over Sterility Concerns
Areazine synthesizes this FDA recall directly from FDA's official public data feed. 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 April 6, 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 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.
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
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.