Reported Sep 9, 2026 · Ongoing · Updated Sep 16, 2026

NaturaLyte, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-1251-1, 08-2251-0, 08-2301-3,…

Fresenius Medical Care Renal Therapies Group, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Fresenius Medical Care Renal Therapies Group, LLC · 920 Winter St Bld 920 · Waltham, MA · 02451-1521

Is this the product you have?

  • NaturaLyte, Liquid Acid Concentrate
  • for Bicarbonate HemodialysisProduct
  • Numbers08-1251-1, 08-2251-0, 08-2301-3, 08-3251-9, 08-3301-2, 13-2201-5, 13-2251-0, 13-3251-9; Liquid Acid Concentrate for Bicarbonate Hemodialysis
Lot codes and dates

8 of 8 products

Products covered by this recall
#BarcodesProduct as published
10084086110165808-1251-1, UDI/DI 00840861101658, Lot Numbers: 26AXAC056
20084086110169608-2251-0, UDI/DI 00840861101696, Lot Numbers: 26AXAC050, 26BXAC012, 26BXAC042
30084086110170208-2301-3, UDI/DI 00840861101702, Lot Numbers: 26BXAC013, 26BXAC045
40084086110174008-3251-9, UDI/DI 00840861101740, Lot Numbers: 26AXAC051, 26BXAC011, 26BXAC043
50084086110175708-3301-2, UDI/DI 00840861101757, Lot Numbers: 26AXAC052
60084086110184913-2201-5, UDI/DI 00840861101849, Lot Numbers: 26AXAC062, 26AXAC064
70084086110186313-2251-0, UDI/DI 00840861101863, Lot Numbers: 26AXAC041, 26AXAC058, 26AXAC059, 26AXAC065, 26BXAC001, 26BXAC003, 26BXAC005, 26BXAC034, 26BXAC049, 26BXAC051
80084086110188713-3251-9, UDI/DI 00840861101887, Lot Numbers: 26BXAC037, 26BXAC048.
Amount recalled
2,998 cs; 68 ea

This recall covers 7 products

The agency filed one notice per product. You are reading one of them; the other 6 are below.

Where it was sold

  • Nationwide

Why it was recalled

Complaints of blue-green discoloration in product

This product could cause temporary or reversible health problems — stop using it.

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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (Enforcement Report)

Read the FDA (weekly enforcement report) notice

Data as of Sep 19, 3:29 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.