FDA action counts
| Total FDA actions | 4 |
|---|---|
| Warning letters | 0 |
| Recalls | 4 |
| Approval records | 0 |
| Form 483 inspection citations | 0 |
| Most recent action | September 16, 2026 |
Risk pattern analysis
Argus HQ analysis — not an FDA finding
This section is Argus HQ analysis, not an FDA finding. Nipro Renal Soultions USA, Corporation has 4 separate FDA recalls on file, more than a single isolated recall event. A pattern across multiple FDA touchpoints does not by itself establish that any specific product currently poses a risk; it reflects only the frequency of FDA engagement with this company as recorded in Argus HQ's database. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ does not independently verify FDA's underlying findings; this page summarizes what FDA has published and links back to the original FDA source for each event. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.
Enforcement history
On 2026-09-16, Argus HQ recorded an FDA recall for Nipro Renal Soultions USA, Corporation, rated "high" severity in Argus HQ's classification: Nipro Renal Soultions USA, Corporation — Class II recall: MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X…. On 2026-09-16, Argus HQ recorded an FDA recall for Nipro Renal Soultions USA, Corporation, rated "high" severity in Argus HQ's classification: Nipro Renal Soultions USA, Corporation — Class II recall: MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201. On 2026-09-16, Argus HQ recorded an FDA recall for Nipro Renal Soultions USA, Corporation, rated "high" severity in Argus HQ's classification: Nipro Renal Soultions USA, Corporation — Class II recall: Citric Complete Liquid Citric Acid Concentrate REF: LC+200-D,LC+201, LC+225(4…. On 2026-09-16, Argus HQ recorded an FDA recall for Nipro Renal Soultions USA, Corporation, rated "high" severity in Argus HQ's classification: Nipro Renal Soultions USA, Corporation — Class II recall: Citric Complete Dry Citric Acid Concentrate REF: DCA+200-25 & DCA+203-25. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed.
Frequently asked questions
- How many FDA actions has Nipro Renal Soultions USA, Corporation had?
- Argus HQ has recorded 4 FDA events for Nipro Renal Soultions USA, Corporation: 0 warning letters, 4 recalls, 0 approvals, and 0 Form 483 inspection observations. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.
- What is the most recent FDA action against Nipro Renal Soultions USA, Corporation?
- The most recent FDA event Argus HQ has on file for Nipro Renal Soultions USA, Corporation is dated 2026-09-16, with a severity rating of "high" in Argus HQ's classification. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.
- Does Argus HQ track new FDA actions for Nipro Renal Soultions USA, Corporation automatically?
- Yes. Argus HQ ingests FDA sources daily, including FDA warning letters, recalls, drug and biologic approvals, and Form 483 inspection observations. When a new FDA action linked to Nipro Renal Soultions USA, Corporation is observed, this page's event count and history update automatically.
- How many FDA actions does Argus HQ track for Nipro Renal Soultions USA, Corporation?
- 4 total: 0 warning letters, 4 recalls, 0 approval records, and 0 Form 483 inspection citations.
Every FDA action tied to this company, the week it happens.
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Related enforcement actions
- Nipro Renal Soultions USA, Corporation — Class II recall: Citric Complete Dry Citric Acid Concentrate REF: DCA+200-25 & DCA+203-25 →
- Nipro Renal Soultions USA, Corporation — Class II recall: Citric Complete Liquid Citric Acid Concentrate REF: LC+200-D,LC+201, LC+225(4… →
- Nipro Renal Soultions USA, Corporation — Class II recall: MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201 →
- Nipro Renal Soultions USA, Corporation — Class II recall: MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X… →
Compare with
- Nipro Renal Soultions USA, Corporation vs Philips North America
- Nipro Renal Soultions USA, Corporation vs Medline Industries, LP
- Nipro Renal Soultions USA, Corporation vs Boston Scientific Corporation
- Nipro Renal Soultions USA, Corporation vs Baxter Healthcare Corporation
- Nipro Renal Soultions USA, Corporation vs PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Two different companies merged onto this page by mistake? Or a name variant missing? Tell us — corrections@argushq.ai
Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Verified from FDA.gov · Last updated: Sep 16, 2026Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). FDA Enforcement History: Nipro Renal Soultions USA, Corporation. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/company/nipro-renal-soultions-usa-corporation
"FDA Enforcement History: Nipro Renal Soultions USA, Corporation." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/company/nipro-renal-soultions-usa-corporation.
Argus HQ Research. "FDA Enforcement History: Nipro Renal Soultions USA, Corporation." Digital Empire Holdings LLC. Accessed September 23, 2026. https://argushq.ai/company/nipro-renal-soultions-usa-corporation.
@misc{argushq_argushq_ai_company_nipro_renal_soultions_usa_corporation_2026,
title = {FDA Enforcement History: Nipro Renal Soultions USA, Corporation},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire Holdings LLC},
url = {https://argushq.ai/company/nipro-renal-soultions-usa-corporation},
note = {Accessed: September 23, 2026}
}Source: FDA.gov (aggregated across Warning Letters, Recalls, Approvals, Form 483s) ↗

