Recall D-0182-2026

US Class I Ongoing · initiated 2025-11-06

Recalling firm

Fresenius Kabi USA, LLC, IL

Product

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.

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