medical MODERATE Updated 2026-09-16

Nipro Renal Soultions USA, Corporation recalls MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB

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Recalled Product

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

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Hazard / Issue

Hemodialysis concentrates contain high endotoxin levels

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: DB+201-2.1: Lot -NDB5E004(exp.4/30/2027) DB+201-25: Lots - NDB5M011(Exp.12/05/2027, NDB4J003(exp.9/25/2026)

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

Looking for a safe alternative?

Search Amazon for MedicaLyte Bicarbonate Powder →

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View official government recall

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