Fresenius Kabi USA, LLC recalled 2,199,850 vials of Famotidine Injection on November 6, 2025. The recall follows reports of microbial contamination and endotoxin testing failures. Healthcare providers and consumers should stop using this product immediately.
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Consumers and healthcare providers should stop using this product immediately. Contact Fresenius Kabi USA, LLC or your healthcare provider for guidance. Notification method: Letter
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The recall includes Famotidine Injection, USP, 20 mg per 2 mL, sold in 2 mL vials. The recalled lot numbers are 6133156, 6133194, and 6133388, with expiration dates of August 2026 and October 2026.
The product poses a high risk due to microbial contamination. This contamination can lead to serious infections, especially in immunocompromised patients.
No specific incidents of illness have been reported. The recall is precautionary, stemming from out-of-limit results obtained during endotoxin testing.
Stop using Famotidine Injection immediately. Contact Fresenius Kabi USA, LLC or your healthcare provider for further guidance.
For questions, call Fresenius Kabi USA, LLC at 1-800-XXX-XXXX or visit their website at www.fresenius-kabi.com.
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