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Lower risk Medical device recall · FDA · Published November 22, 2024

Nipro Renal Solutions Citric Complete Dry Citric Acid Concentrate Recall: Mislabeled

Nipro Renal Solutions recalls Citric Complete Dry Citric Acid Concentrate (Model DCA+225-25) due to mislabeled chemical composition. Affected lots: NDC4F001, NDC4G006, NDC4H009, NDC4H010.

🇺🇸 FDA recall #Z-0820-2025Medical deviceNipro Renal Solutions ›
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Contact the company

Recalling firmNipro Renal Soultions USA, Corporation509 Fishing Creek Rd · Lewisberry, PA 17339-9517
✎ GovInfoNow plain-language explainer

Nipro Renal Solutions is recalling Citric Complete Dry Citric Acid Concentrate (Model DCA+225-25) because the outer case incorrectly labels the chemical composition as 3.0 K, 2.0 Ca instead of 2.0 K, 3.0 Ca. This mislabeling could lead to incorrect usage in medical applications where precise chemical ratios are critical. Read more at govinfonow.com/recall/53424-nipro-renal-solutions-citric-complete-dry-citric-acid-concentrate-recall.

Source Summary by GovInfoNow · govinfonow.com/recall/53424-nipro-renal-solutions-citric-complete-dry-citric-acid-concentrate-recall · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0820-2025

Cite this page

“Nipro Renal Solutions Citric Complete Dry Citric Acid Concentrate Recall: Mislabeled.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53424-nipro-renal-solutions-citric-complete-dry-citric-acid-concentrate-recall. Based on FDA recall #Z-0820-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0820-2025%22&limit=1).

The FDA announced on Nov. 22, 2024, that Nipro Renal Solutions USA, Corporation is recalling Citric Complete - Dry Citric Acid Concentrate Model Number DCA+225-25 because the outer case is mislabeled with incorrect potassium and calcium levels.

How to tell if you have it

  • Brand: Nipro Renal Solutions
  • Product: Citric Complete - Dry Citric Acid Concentrate
  • Model Numbers: DCA+225-25
  • Lot Numbers: NDC4F001, NDC4G006, NDC4H009, NDC4H010
  • Quantity: 2,810 units
  • Distribution: US states including AZ, FL, GA, IL, MI, NC, NJ, OH, TN, TX

The hazard

The hazard is that the outer case is mislabeled as 3.0 K, 2.0 Ca instead of 2.0 K, 3.0 Ca.

Context

GovInfoNow's records show Nipro Renal Soultions USA, Corporation has 2 other recalls on record since 2025-04-11. Other recent recalls of similar products include NIPRO Conductivity Solutions Risk Incorrect Dialysate Calibration (2025-12-12), Fresenius Medical Care Bicarby Dialysate Recall: Incorrect Labeling Risk (2026-05-07), and Fresenius Medical Care Citrasate Liquid Acid Concentrate Recall: Blue-Green Discoloration Complaint (2026-07-14).

How to tell if you have this one

Check for the model number DCA+225-25 on the product packaging. Affected lots include NDC4F001, NDC4G006, NDC4H009, and NDC4H010.

  • Brand
    Nipro Renal Solutions
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Label

    Verify the model number and lot numbers on the packaging to determine if it is affected.

Where it went and when

Where it was distributed

Distributed in 10 states.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: yesILWisconsin: not listedWIMichigan: yesMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: yesOHPennsylvania: not listedPANew Jersey: yesNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: yesAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: yesGAHawaii: not listedHITexas: yesTXFlorida: yesFL

FDA distribution: “US distribution to states of: AZ, FL, GA, GA, IL, MI, NC, NJ, OH, TN, TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Arizona, Florida, Georgia, Illinois, Michigan, New Jersey, North Carolina, Ohio, Tennessee, Texas.

Recall timeline

FDA published this recall 54 days after the firm started it.

1. Firm started the recall: Nov 22, 202412. FDA classified it Class II: Jan 8, 202523. Published in FDA’s Enforcement Report: Jan 15, 2025320242025
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0820-2025 (November 22, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0820-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA