Fresenius Kabi Compounding, LLC Recalls Thiamine HCl Injection Due to Lack of Sterility Assurance

What Happened

Fresenius Kabi Compounding, LLC has initiated a voluntary recall of thiamine HCl (500 mg added to 100 mL, 0.9% Sodium Chloride Injection, USP) due to a lack of assurance of sterility. The recall, classified as Class II by the FDA, was initiated by the firm on February 5, 2026, following concerns that the product’s sterile integrity could not be guaranteed.

Which Products Are Affected

The recall affects 10,548 bags distributed nationwide across the United States. The specific product details are as follows:

• Product Name: thiamine HCl, 500 mg, 500 mg added to 100 mL, 0.9% Sodium Chloride Injection, USP
• Labeler: Fagron Sterile Services
• NDC: 71506-079-56
• Recalling Firm: Fresenius Kabi Compounding, LLC (Canton, MA)
• Affected Lot Numbers and Expiration Dates:
  • Lot # C274-000047651 (Exp: 7-Feb-26)
  • Lot # C274-000048671 (Exp: 30-Mar-26)
  • Lot # C274-000048828 (Exp: 7-Apr-26)
  • Lot # C274-000049121 (Exp: 19-Apr-26)
  • Lot # C274-000049127 (Exp: 21-Apr-26)
  • Lot # C274-000049252 (Exp: 26-Apr-26)
  • Lot # C274-000049260 (Exp: 28-Apr-26)
  • Lot # C274-000049401 (Exp: 3-May-26)
  • Lot # C274-000049413 (Exp: 5-May-26)
  • Lot # C274-000049571 (Exp: 10-May-26)
  • Lot # C274-000049581 (Exp: 12-May-26)
  • Lot # C274-000049584 (Exp: 13-May-26)
  • Lot # C274-000049717 (Exp: 17-May-26)
  • Lot # C274-000049727 (Exp: 18-May-26)

What You Should Do

Healthcare providers and facilities should immediately check their inventory for the affected lot numbers listed above. Any impacted products should be quarantined and not administered to patients. The firm notified customers of the recall via letter. For information regarding the return process or to address questions, contact Fresenius Kabi Compounding, LLC at their facility located at 20 Dan Rd, Canton, MA 02021.

Why This Matters

A lack of assurance of sterility in an injectable medication poses a serious health risk, as the administration of a non-sterile drug can lead to life-threatening infections or other severe medical complications.

Source

This information is based on official recall data provided by the FDA (Recall Number: D-0335-2026).