Class I — UrgentReported 2025-12-03

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).

Reason for Recall

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

Recall Number

D-0182-2026

Classification

Class I

Status

Ongoing