FDAFDA recall Z-3134-2026 · Sep 16, 2026
Nipro Renal Soultions USA, Corporation: MedicaLyte Bicarbonate Powder REF: DB+201-2 recall
Recall found
Product
MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X))
Reason for recall
Hemodialysis concentrates contain high endotoxin levels
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots 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)
- Quantity
- 2,327 cases
- 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.
- Recalling firm
- Nipro Renal Soultions USA, Corporation, Lewisberry, PA
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-08-05
Source: openFDA enforcement record Z-3134-2026 · search recall number Z-3134-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.