Fresenius Kabi USA, LLC: Drug Recall

Recall #D-0182-2026 · 11/06/2025

Class I: Dangerous

Recall Details

Recall Number: D-0182-2026
Classification: Class I
Product Type: Drug
Recalling Firm: Fresenius Kabi USA, LLC
Status: Ongoing
Date Initiated: 11/06/2025
Location: Lake Zurich, IL, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2,199,850 vials

Reason for Recall

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

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).

Distribution Pattern

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

Other Recalls by Fresenius Kabi USA, LLC

Class II: Risk 11/21/2025

Emphasizing instructions for LVP duration programming located in the IFU.
Class I: Dangerous 11/14/2025

Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
Class II: Risk 11/03/2025

Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.
Class I: Dangerous 11/03/2025

Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
Class II: Risk 09/03/2025

Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.

View all recalls by Fresenius Kabi USA, LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.