The Recall Desk
SevereFDA (Devices)·Z-3135-2026·Announced 2026-09-16

Nipro Citric Complete Dry Citric Acid Concentrate Recalled for High Endotoxin Levels

Nipro Renal Solutions is recalling Citric Complete Dry Citric Acid Concentrate due to high endotoxin levels. The product is used in hemodialysis.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. The presence of high endotoxin levels in hemodialysis concentrates poses a significant risk of serious injury, meeting the criteria for a Severe rating.

Plain-English summary

Nipro Renal Solutions USA, Corporation is recalling 7,770 cases of Citric Complete Dry Citric Acid Concentrate (REF: DCA+200-25 & DCA+203-25). The recall was initiated because the hemodialysis concentrate contains high endotoxin levels.

The affected product was distributed nationwide in the United States in the states of FL, GA, IL, MD, MI, NC, NJ, NV, OH, and PA, as well as in Guatemala and Panama. Specific lot numbers and expiration dates are listed in the recall documentation.

Healthcare facilities and consumers should stop using the affected product and contact Nipro Renal Solutions for instructions on how to return it.

The recalled product

Product
Citric Complete Dry Citric Acid Concentrate REF: DCA+200-25 & DCA+203-25
Manufacturer
Nipro Renal Soultions USA, Corporation
Category
Medical Device — Dialysis Supplies
Hazard
Affected units
7,770

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (8)

  • DCA+200-25 : Lots - NDC5E015(Exp.5/20/2027)
  • NDC5E016(Exp.5/21/2027)
  • NDC5E017(Exp.5/22/2027)
  • NDC5E019(Exp.5/29/2027)
  • NDC5E012(Exp.5/19/2027)
  • NDC5B017(Exp.2/24/2027)
  • NDC5C023(Exp.3/24/2027) DCA+203-25: NDC5C026(Exp.3/27/2027)
  • NDC5L026(Exp.11/17/2027)

Distribution

Distributed nationwide across the United States.

The notice also names 10 states specifically:

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