Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials

Fresenius Kabi USA, LLC has recalled Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on December 3, 2025 and was initiated on November 6, 2025. It is classified as a Class I recall, which means there is a reasonable chance that using this product could cause serious health problems or death.

Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.

What was recalled?

This recall covers Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, with approximately 2,199,850 vials affected. The company behind the recall is Fresenius Kabi USA, LLC, based in Lake Zurich, IL. The FDA describes the product as: “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).”

Why was Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials recalled?

According to the FDA, the stated reason for the recall is: “Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.” In plain terms, this recall relates to a sterility or contamination concern.

Sterile medicines, such as injectables and eye drops, must be completely free of microorganisms and stray particles. This recall means that sterility could not be assured or that contamination was found or suspected. Using a non-sterile product of this kind can cause infections, which is why these recalls are treated seriously.

What should you do?

If you think you may have bought Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, compare it against the product description and identifying codes (Lot #: 6133156, 6133194, Exp Date: 08/2026; 6133388, Exp Date: 10/2026.) before using it. This recall is currently listed as ongoing.

The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact Fresenius Kabi USA, LLC or your local health authority.

About this recall

This recall was distributed in IL. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.