Fresenius Kabi Compounding recalled 1,057 bags of Acyclovir Sodium Injection on February 5, 2026. The recall stems from a lack of assurance of sterility, posing a high health risk. Healthcare providers should cease use immediately and contact the manufacturer for guidance.
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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This recall affects Acyclovir Sodium, 200 mg per 100 mL, packaged in single-use bags. The recalled lot number is C274-000049124, with an expiration date of February 28, 2026. The product was distributed nationwide in the United States.
The lack of assurance of sterility poses a significant risk of infection to patients receiving this intravenous medication. Injections that are not sterile can lead to serious complications, including sepsis.
There are currently no reported injuries or incidents linked to this recall. However, the potential for serious health risks necessitates immediate action from consumers and healthcare providers.
Stop using the Acyclovir Sodium Injection immediately. Contact Fresenius Kabi Compounding, LLC or your healthcare provider for further guidance and potential return procedures.
For more information, contact Fresenius Kabi Compounding at 1-800-XXX-XXXX. Additional details can be found at the FDA's recall page: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0333-2026.
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