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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Thiamine HCl Injection is used to treat thiamine deficiency and is commonly administered in clinical settings. Healthcare providers often use it in patients who require supplemental thiamine, especially those with certain medical conditions.
The lack of assurance of sterility means that the injection could be contaminated, leading to potential infections or adverse health effects for patients.
This recall is not part of a broader industry pattern.
Consumers and healthcare providers must act quickly to stop using the affected product to avoid serious health risks.
The lot number and expiration date are typically found on the label of the product packaging.
Refund processing may take 4-6 weeks after the return of the recalled product.
Keep a record of the lot number, expiration date, and any correspondence regarding the recall.
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.
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