Drug recall D-0182-2026

Class I Ongoing reported Dec 3, 2025

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.

Lots and codes

Lot #: 6133156, 6133194, Exp Date: 08/2026; 6133388, Exp Date: 10/2026.

Recall details

Recalling firm
Fresenius Kabi USA, LLC, Lake Zurich, IL
Quantity
2,199,850 vials
Distribution
Nationwide within the United States as well as AK, HI, and PR.
Type
Voluntary: Firm initiated
Recall initiated
November 6, 2025

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