Fresenius Kabi Compounding recalled 10,548 bags of thiamine HCl injection on February 5, 2026. The recall follows a lack of assurance of sterility, posing a high health risk. Affected products include several lots expiring between February and May 2026.
Lack of Assurance of Sterility
Consumers and healthcare providers should stop using this product immediately. Contact Fresenius Kabi Compounding, LLC or your healthcare provider for guidance. Notification method: Letter
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The recall involves thiamine HCl, 500 mg added to 100 mL of 0.9% Sodium Chloride Injection, USP. The affected lot numbers include C274-000047651, C274-000048671, C274-000048828, among others. The product was distributed nationwide in the U.S.
The recall was initiated due to a lack of assurance of sterility, which can lead to serious health complications if contaminated. As a Class II recall, it indicates a temporary or medically reversible health hazard.
No specific incidents have been reported related to this recall. However, the potential for infection or adverse reactions due to non-sterile conditions remains a serious concern.
Stop using this product immediately. Contact Fresenius Kabi Compounding, LLC or your healthcare provider for further guidance. A notification letter has been issued to inform consumers.
For more information, contact Fresenius Kabi Compounding, LLC. Visit the FDA website for details on the recall.
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