Thiamine HCl Sodium Chloride Injection Recalled for Lack of Sterility Assurance
Key Clinical Summary
- The US FDA is monitoring a voluntary, firm-initiated Class II recall of thiamine HCl 500 mg in 100 mL 0.9% Sodium Chloride Injection, involving 10 548 IV bags distributed nationwide with expiration dates through May 3, 2026.
- The recall was initiated due to lack of assurance of sterility, a quality issue that may result in temporary or medically reversible adverse health consequences.
- Thiamine injection is indicated for the treatment and prevention of thiamine deficiency, commonly used in hospital and emergency care settings.
A Class II recall has been issued for thiamine HCl 500 mg added to 100 mL 0.9% Sodium Chloride Injection, USP, prepared by Fagron Sterile Services (20 Dan Road, Canton, MA 02021) and labeled under NDC 71506-079-56. The recall affects 10 548 IV bags distributed nationwide in the US. Impacted lots include C274-000047651 (Exp 7-Feb-26), C274-000048671 (Exp 30-Mar-26), C274-000048828 (Exp 7-Apr-26), C274-000049121 (Exp 19-Apr-26), C274-000049127 (Exp 21-Apr-26), C274-000049252 (Exp 26-Apr-26), C274-000049260 (Exp 28-Apr-26), and C274-000049401 (Exp 3-May-26), among others.
The recall was voluntarily initiated on February 5, 2026, and classified by the FDA as Class II on February 13, 2026. The updated reason for recall is “Lack of Assurance of Sterility.” A Class II designation indicates that use of the affected product may cause temporary or medically reversible adverse health consequences, though the probability of serious harm is low. No public press release has been issued; notification was provided to consignees via letter. The recalling firm is listed as Fresenius Kabi Compounding, LLC, Canton, MA.
Thiamine (vitamin B1) injection is commonly used for the treatment or prevention of thiamine deficiency, including in patients with malnutrition, chronic alcoholism, or Wernicke’s encephalopathy, and in other acute care settings. Because this product is administered intravenously, sterility assurance is critical. Pharmacists should immediately identify and quarantine affected lots, notify clinical teams, and ensure replacement supply to avoid interruption of therapy in inpatient and emergency care settings.
Reference
FDA. Enforcement Report. February 18, 2026. Accessed February 19, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm
