Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA...
FDA Recall #D-0182-2026 — Class I — November 6, 2025
Product Description
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.
Recalling Firm
Fresenius Kabi USA, LLC — Lake Zurich, IL
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
2,199,850 vials
Distribution
Nationwide within the United States as well as AK, HI, and PR.
Code Information
Lot #: 6133156, 6133194, Exp Date: 08/2026; 6133388, Exp Date: 10/2026.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated