Nipro Renal Soultions USA, Corporation recalls MedicaLyte Bicarbonate Powder REF: DB+201-2.1
- Recalling company
- Nipro Renal Soultions USA, Corporation
- Product
- MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X))
- Reason
- Hemodialysis concentrates contain high endotoxin levels
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Aug 5, 2026
- Reported
- Sep 16, 2026
- Distribution
- Worldwide - US Nationwide distribution in the states of FL, GA, IL, MD, MI, NC, NJ, NV, OH, PA, and the countries of Guatemala and Panama.
- Status
- Ongoing
- Quantity
- 2,327 cases
- Lot / codes
- DB+201-2.1: Lot -NDB5E004(exp.4/30/2027) DB+201-25: Lots - NDB5M011(Exp.12/05/2027, NDB4J003(exp.9/25/2026)
- Company location
- Lewisberry, PA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-3134-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-3134-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.