Latest recalls
FDAClass IISeptember 16, 2026

MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X))

Why it was recalled

Hemodialysis concentrates contain high endotoxin levels

What to do

The recall is ongoing. Follow the firm and FDA instructions.

Affected products and identifiers

DB+201-2.1: Lot -NDB5E004(exp.4/30/2027) DB+201-25: Lots - NDB5M011(Exp.12/05/2027, NDB4J003(exp.9/25/2026) — 2,327 cases

Record details

Nipro Renal Soultions USA, Corporation — 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.

Open FDA enforcement record