ketamine HCl, 1,000 mg, 1,000 mg per 100 mL (10 mg per mL) in Sodium Chloride Injection, Fagron S...
FDA Recall #D-0334-2026 — Class II — February 5, 2026
Product Description
ketamine HCl, 1,000 mg, 1,000 mg per 100 mL (10 mg per mL) in Sodium Chloride Injection, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-050-56
Reason for Recall
Lack of Assurance of Sterility
Recalling Firm
Fresenius Kabi Compounding, LLC — Canton, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
1410 bags
Distribution
US Nationwide.
Code Information
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
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated