Fresenius Kabi Compounding recalled 1,578 bags of vancomycin HCl injection on February 5, 2026. The company cited a lack of assurance of sterility as the reason for the recall. Healthcare providers and consumers should stop using the product immediately.
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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Vancomycin HCl is an antibiotic used to treat serious infections. Healthcare professionals prescribe it for patients who are allergic to penicillin or when other antibiotics are ineffective.
The lack of assurance of sterility means that the product may contain harmful microorganisms that could lead to infections. This risk is particularly significant for patients receiving injections, as they are directly exposed to the medication without any barriers.
This recall is not part of a broader industry pattern.
The recall affects healthcare providers and patients relying on vancomycin for treatment. The urgency of the recall emphasizes the potential health risks associated with non-sterile injectable medications.
Lot numbers and expiration dates are typically found on the product label or packaging.
Expect a refund or replacement processing time of approximately 4-6 weeks.
Keep a record of your purchase, including receipts and product labels. Document any correspondence regarding the recall.
The affected product is vancomycin HCl, 1.5 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP. It was distributed nationwide in the United States and has the NDC 71506-016-59. The lot number is C274-000049628, with an expiration date of May 3, 2026.
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Fresenius Kabi Compounding recalled its vancomycin HCl injection on February 5, 2026, due to a lack of assurance of sterility. This Class II recall affects all lots distributed nationwide. Healthcare providers and consumers must stop using the product immediately.
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