FDA recall, , Moderate risk
MedicaLyte and Citric Complete Concentrates
Hemodialysis concentrates contain high endotoxin levels.
Summary by Recall Canary from the FDA notice
What happened
Nipro Renal Soultions USA, Corporation of Lewisberry, Pennsylvania, recalled hemodialysis concentrates because they contain high endotoxin levels. The products include Citric Complete Dry Citric Acid Concentrate, MedicaLyte Liquid Bicarbonate Concentrate, MedicaLyte Bicarbonate Powder, and Citric Complete Liquid Citric Acid Concentrate.
The recall began August 5, 2026, and was added to the FDA's Enforcement Report on September 10, 2026. Distribution was in the states of FL, GA, IL, MD, MI, NC, NJ, NV, OH, PA, and the countries of Guatemala and Panama.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
4 products
Affected if its lot code is listed.
Citric Complete Dry Citric Acid Concentrate REF: DCA+200-25 & DCA+203-25
- Lot code
- NDC5E015
MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201
- Lot code
- N4L022
- N4L010
MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X))
- Lot code
- NDB5E004
- NDB5M011
Citric Complete Liquid Citric Acid Concentrate REF: LC+200-D,LC+201, LC+225(45X)
- Lot code
- N4J030
- N6A025
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution in the states of Florida, Georgia, Illinois, Maryland, Michigan, North Carolina, New Jersey, Nevada, Ohio, Pennsylvania, and the countries of Guatemala and Panama.
- Company
- Nipro Renal Soultions USA, CorporationLewisberry, Pennsylvania
- Hazard
- Contamination
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99573
- Recall numbers
- Z-3133-2026 to Z-3136-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
