Reported Sep 16, 2026 · Ongoing
MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X))
Nipro Renal Soultions USA, Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Nipro Renal Soultions USA, Corporation · 509 Fishing Creek Rd · Lewisberry, PA · 17339-9517
Is this the product you have?
- MedicaLyte Bicarbonate Powder REF
DB+201-2.1(45X) and DB+201-25 (35X36.83X45X))
- Lot codes and dates
- DB+201-2.1: Lot -NDB5E004(exp.4/30/2027) DB+201-25: Lots - NDB5M011(Exp.12/05/2027, NDB4J003(exp.9/25/2026)
- Amount recalled
- 2,327 cases
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
Hemodialysis concentrates contain high endotoxin levels
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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