FDA-Device2026-09-16Class IIPROCESSING DEFECT
Nipro Citric Complete Dry Citric Acid Concentrate recalled for high endotoxin levels
What this means
Nipro Renal Solutions USA is recalling specific lots of Citric Complete Dry Citric Acid Concentrate used in hemodialysis because they contain higher-than-safe levels of endotoxin, a bacterial substance. The affected product was distributed nationwide and internationally.
- If you use or manage hemodialysis equipment, check if you have any of the affected lot numbers (NDC5E015, NDC5E016, NDC5E017, NDC5E019, NDC5E012, NDC5B017, NDC5C023, NDC5C026, or NDC5L026).
- Contact Nipro Renal Solutions USA or your supplier for instructions on returning or replacing affected concentrate.
- Do not use concentrate from recalled lots without guidance from Nipro or your dialysis center.
The agency's original wording
Hazard
Hemodialysis concentrates contain high endotoxin levels
Intended for
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
7,770 cases
Manufactured in
509 Fishing Creek Rd, Lewisberry, PA, United States
Products
Citric Complete Dry Citric Acid Concentrate REF: DCA+200-25 & DCA+203-25
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3135-2026More Nipro recalls
- FDA-Device2026-09-16Nipro MedicaLyte Bicarbonate Powder recalled for high endotoxin levels in hemodialysis concentrate
- FDA-Device2026-09-16Nipro Renal Solutions Citric Complete hemodialysis concentrate recalled for high endotoxin levels
- FDA-Device2026-09-16Nipro MedicaLyte Liquid Bicarbonate Concentrate recalled for high endotoxin levels in hemodialysis concentrate
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