Fresenius Kabi Compounding Recalls Ketamine HCl Injection Over Sterility Concerns

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.