thiamine HCl, 500 mg, 500 mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile...
FDA Recall #D-0335-2026 — Class II — February 5, 2026
Product Description
thiamine HCl, 500 mg, 500 mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-079-56.
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
10,548 bags
Distribution
US Nationwide.
Code Information
Lot # C274-000047651, Exp Date: 7-Feb-26; Lot # C274-000048671, Exp Date: 30-Mar-26; Lot # C274-000048828, Exp Date: 7-Apr-26; Lot # C274-000049121, Exp Date: 19-Apr-26; Lot # C274-000049127, Exp Date: 21-Apr-26; Lot # C274-000049252, Exp Date: 26-Apr-26; Lot # C274-000049260, Exp Date: 28-Apr-26; Lot # C274-000049401, Exp Date: 3-May-26; Lot # C274-000049413, Exp Date: 5-May-26; Lot # C274-000049571, Exp Date: 10-May-26; Lot # C274-000049581, Exp Date: 12-May-26; Lot # C274-000049584, Exp Date: 13-May-26; Lot # C274-000049717, Exp Date: 17-May-26; Lot # C274-000049727, Exp Date: 18-May-26.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated