Fresenius Kabi USA, LLC recalls Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, LLC, NDC 63323-739-1…

Recall date

November 6, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0182-2026

FDA classification

Class I

Brand / firm

Fresenius Kabi USA, LLC

Sold / distributed

Nationwide within the United States as well as AK, HI, and PR.

Why it was recalled

Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was 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).