Fresenius Kabi Compounding recalled 1,410 bags of ketamine HCl injection on February 5, 2026. The recall stems from a lack of assurance of sterility, posing a high health risk. Healthcare providers and consumers must stop using this 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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The recall involves ketamine HCl, 1,000 mg per 100 mL (10 mg per mL) in Sodium Chloride Injection. The affected lot numbers include C274-000047883, C274-000048515, C274-000048679, C274-000049119, and C274-000049282. The product was distributed nationwide in the U.S.
The recall is due to a lack of assurance of sterility, which could lead to serious infections if the contaminated product is used. The FDA classified this recall as Class II, indicating a potential for temporary or medically reversible adverse health consequences.
To date, there have been no reported incidents or injuries associated with this recall. However, consumers are advised to take the situation seriously due to the high-risk nature of the product.
Stop using the ketamine HCl injection immediately. Contact Fresenius Kabi Compounding, LLC or your healthcare provider for further guidance. A notification letter has been sent to affected parties.
For questions or concerns, contact Fresenius Kabi Compounding, LLC at their customer service line. More information is available on the FDA's website.
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