Fresenius Kabi Compounding, LLC Recalls Thiamine HCl Injection Due to Lack of Sterility Assurance
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Fresenius Kabi Compounding, LLC has voluntarily recalled over 10,000 bags of Thiamine HCl injection distributed nationwide due to concerns regarding sterility assurance.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on February 24, 2026 and geographically references United States. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — FDA Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.
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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).
Original source: FDA Official Notice ↗
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