Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Famotidine Injection Recalled by Fresenius Kabi USA, LLC Due to Microbial Contamination of Sterile Products; out of limit...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Fresenius Kabi USA, LLC directly.
Affected Products
Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, LLC, NDC 63323-739-11 (unit of use), 63323-739-12 (unit of sale).
Quantity: 2,199,850 vials
Why Was This Recalled?
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Fresenius Kabi USA, LLC
Fresenius Kabi USA, LLC has 67 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report