FDA Recall D-0182-2026

Fresenius Kabi USA, LLC · Lake Zurich, IL

Class I — life-threatening Ongoing 189 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

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).

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

Quantity: 2,199,850 vials

Reason for recall

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

Recall record

Recall number: D-0182-2026
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide within the United States as well as AK, HI, and PR.
Recall initiated: 2025-11-06
Classified by FDA Center: 2025-11-26
FDA published: 2025-12-03
Recalling firm: Fresenius Kabi USA, LLC
Firm location: Lake Zurich, IL

Drug identification

Brand name(s): FAMOTIDINE
Generic name(s): FAMOTIDINE
Manufacturer(s): Fresenius Kabi USA, LLC
NDC(s): 63323-739
Route(s): INTRAVENOUS

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

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