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Recall Observatory FDA recall evidence

Drug 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).

D-0182-2026

November 06, 2025

Class I

Product summary

Firm
Fresenius Kabi USA, LLC
Event
Event 97945
Status
Ongoing
Classification
Class I
Quantity
2,199,850 vials
Official record key
drug-enforcement:D-0182-2026

Official wording

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

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

Distribution pattern: Nationwide within the United States as well as AK, HI, and PR.

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    Microbial Contamination