United StatesFamotidine Injection, USP 20 mg per 2 mL (10 mg per mL) in 2 mL vials from Fresenius Kabi USA, LLC, NDC 63323-739-11 (unit of use) and 63323-739-12 (unit of sale), lots 6133156 and 6133194 (exp. 08/2026) and 6133388 (exp. 10/2026) is affected. The product was recalled due to suspected microbial contamination and out-of-limit endotoxin test results.
What's being recalled
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).
Recalling firm: Fresenius Kabi USA, LLC, Lake Zurich, IL, United States.
How to identify it
Lot #: 6133156, 6133194, Exp Date: 08/2026; 6133388, Exp Date: 10/2026.
The hazard
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Nationwide within the United States as well as AK, HI, and PR.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)