Fresenius Kabi USA, LLC recalls 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),…
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Read the official notice →- Date
- 2025-12-03
- Country
- United States
- Brand
- Fresenius Kabi
- 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),…
- Classification
- Class I
- Units
- Nationwide within the United States as well as AK, HI, and PR.
- Category
- Drugs & medical
- Source
- FDA · Drug
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Fresenius Kabi recalls
- 2025-12-24
USFresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
FDA · DeviceFresenius Kabi USA, LLCUS (Domestic) distribution: CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NJ,…Official notice →- 2025-12-10
- US
Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.
FDA · DeviceFresenius Kabi USA, LLCUS Nationwide distribution in the sates of CA, CO, FL, GA, ID, IL, MD, MI, MN,…Official notice → - US
Fresenius Kabi USA, LLC recalls IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Large Volume…
Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
FDA · DeviceFresenius Kabi USA, LLCUS Nationwide distribution in the states of IL, MD, MI, OK, SC, TX, VA & WI.Official notice → - 2025-11-05
- US
Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.
FDA · DeviceFresenius Kabi USA, LLCUS Nationwide distribution in the state of Minnesota.Official notice → - 2025-08-06
- US
Fresenius Kabi USA, LLC recalls LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Product Code: SET-0032-25.
Potential for external cassette leaks
FDA · DeviceFresenius Kabi USA, LLCUS Nationwide distribution in the states of CA, CO, DE, FL, GA, ID, IL, MA,…Official notice → - 2025-06-18
- US
Fresenius Kabi USA, LLC recalls IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15 mL. Intravascular…
Mis-assembly error of Blood Products Administrations Sets where the 200-micron drip chamber filter may be incorrectly positioned and unable to filter out large blood particulates.
FDA · DeviceFresenius Kabi USA, LLCUS distribution: CA, CO, DE, GA, IL, MD, MI, MN, MS, NC, NJ, NV, OK, SC, TX,…Official notice →
Other drugs & medical recalls in the United States
- 2025-12-03
- US
Olympus Corporation of the Americas recalls Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Model/Catalog Number: HX-400U-30 Used with an…
Potential that the ligation loop was unable to release or detach as expected during use, causing the loop to become unintentionally fixed around patient anatomy.
- US
Glycar SA Pty., Ltd. recalls SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
The impacted lot may not meet the required tensile strength specification.
- US
- US
Medical Products Laboratories, Inc. recalls Walgreens Saline Nasal Spray WITH XYLITOL, 1.5 oz (45mL) bottle, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL…
Microbial contamination of a non-sterile product - microorganism found to be pseudomonas lactis
- 2025-11-26
- US
Sterilmed, Inc. recalls Brand Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Product Name: CATHETER ACUNAV DIAGNOSTIC…
Affected catheters were reprocessed beyond validated cycles. This may compromise device sterility or mechanical integrity of the device and can lead to severe adverse events such as infection, vascular injury or…
FDA · DeviceSterilmed, Inc.United States Only: Kentucky, Maryland, Massachusetts, Mississippi, New…Official notice → - US
Olympus Corporation of the Americas recalls Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name: Olympus Nephro-EZDilate Nephrostomy…
Device kits contained an incorrectly sized 4mm x 4cm urinary tract balloon catheter (BURS0404) instead of the correct 8mm x 15cm nephrostomy tract balloon catheter (BPCN0815). All other components in the kits were…
FDA · DeviceOlympus Corporation of the AmericasUS Domestic: AK, CA, IA, KY, WA, WI; OUS International: Canada and Germany.Official notice →