Nipro Renal Soultions recall: MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201 and 3 more products
Nipro Renal Soultions USA, Corporation is recalling MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201 and 3 more products – 3,286 cases; 2,327 cases; 7,770 cases; 100 drums/1072 cases. The U.S. Food and Drug Administration published the recall on September 16, 2026; it began on August 5, 2026. Distributed nationwide.
Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
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| Product | MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201 and 3 more products |
| Brand | Nipro Renal Soultions |
| Company | Nipro Renal Soultions USA, Corporation |
| Type | Medical devices |
| Classification | Class II |
| Recall date | August 5, 2026 |
| Published by FDA | September 16, 2026 |
| Quantity | 3,286 cases; 2,327 cases; 7,770 cases; 100 drums/1072 cases |
| Recall ID | 99573 |
Recalled products (4)
- MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201
- FDA recall number
- Z-3133-2026
- Codes, lots and dates
- BC-100 - Lot:N4L022 (exp.11/13/2026), N4L037(exp.11/18/2026) BC+201- Lot: N4L010(exp.11/06/2026)
- Quantity
- 3,286 cases
- Classification
- Class II
- MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X))
- FDA recall number
- Z-3134-2026
- 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
- Classification
- Class II
- Citric Complete Dry Citric Acid Concentrate REF: DCA+200-25 & DCA+203-25
- FDA recall number
- Z-3135-2026
- Codes, lots and dates
- 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)
- Quantity
- 7,770 cases
- Classification
- Class II
- Citric Complete Liquid Citric Acid Concentrate REF: LC+200-D,LC+201, LC+225(45X)
- FDA recall number
- Z-3136-2026
- Codes, lots and dates
- LC+200-D: Lot-N4J030 (Exp.9/20/2026), N5D043(Exp.4/16/2027); LC+225: Lot-N6A025(Exp.1/8/2028)
- Quantity
- 100 drums/1072 cases
- Classification
- Class II
Identifiers and details
- FDA event ID
- 99573
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Lewisberry, PA, United States
Why it was recalled
The reason the FDA lists: “Hemodialysis concentrates contain high endotoxin levels”
Where it was sold
Nationwide. Distribution as the FDA records it: “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.”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99573, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
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|---|---|---|---|
| Oct 7, 2026 |  Draeger recall: VentStar Resus NeoMedical devices · 1,063,643 units | Potential cracks in the hose, which could lead to leakage or the hose falling off. Most serious | FDA Class I |
| Oct 7, 2026 | Medline Industries recall: Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories and 1 more productMedical devices · 771,127 total | a fire hazard Most serious | FDA Class I |
| Oct 7, 2026 | Karl Storz Endoscopy recall: HOPKINS Telescope 30¿Medical devices · 6 eyepieces | Due to incorrect inside packaging label for eyepiece. Serious | FDA Class II |
| Oct 7, 2026 | Noxbox recall: NOxBOXi Nitric Oxide Delivery SystemMedical devices · 1,667 units | Potential for irregular oxygen readings due to a manufacturing issue affecting certain oxy… Serious | FDA Class II |
| Oct 7, 2026 | Siemens Healthcare Diagnostics recall: Atellica CH Revised C-Reactive ProteinMedical devices · 42940 units (3938 US, 39002 OUS) | The potential for falsely elevated results. Serious | FDA Class II |
| Oct 7, 2026 | Tandem Diabetes Care recall: T:slim Mobile ApplicationMedical devices · 177 | A beta (early-release) version of the iOS application, version 2.13 (TestFlight) had a sof… Serious | FDA Class II |
About this recall
Is Nipro Renal Soultions MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 recalled?
Yes. Nipro Renal Soultions USA, Corporation recalled it on August 5, 2026; FDA published it September 16, 2026 (Class II). Only the lots, dates or models listed on this page are included.
Why was it recalled?
Hemodialysis concentrates contain high endotoxin levels
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.