Moderate riskFDA DeviceSep 9, 2026Class II

Fresenius NaturaLyte Liquid Acid Concentrate for Hemodialysis recalled for blue-green discoloration

Fresenius Medical Care is recalling specific lots of NaturaLyte Liquid Acid Concentrate used in bicarbonate hemodialysis due to reports of blue-green discoloration in the product. The affected lots were distributed nationwide in the U.S. and in Mexico.

From the FDA notice · Read the official notice ↗ · All Fresenius Medical Care recalls

What to do

Check if you have one of the affected product numbers and lot numbers listed in this recall
Do not use the product if it shows blue-green discoloration
Contact Fresenius Medical Care or your dialysis center for instructions on replacement or disposal

Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product: NaturaLyte, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-1251-1, 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
Sold in: Nationwide
Made for: Adults

This recall covers 3 products — see all of them.

Details

Units affected: 2,998 cs; 68 ea
Illnesses reported: None reported
Manufactured in: 920 Winter St Bld 920, N/A, Waltham, MA, United States
Classification: Class II
Recall number: Z-3092-2026

In the FDA's words

Description: NaturaLyte, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-1251-1, 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 Complaints of blue-green discoloration in product 1) 08-1251-1, UDI/DI 00840861101658, Lot Numbers: 26AXAC056; 2) 08-2251-0, UDI/DI 00840861101696, Lot Numbers: 26AXAC050, 26BXAC012, 26BXAC042; 3) 08-2301-3, UDI/DI 00840861101702, Lot Numbers: 26BXAC013, 26BXAC045; 3) 08-3251-9, UDI/DI 00840861101740, Lot Numbers: 26AXAC051, 26BXAC011, 26BXAC043; 4) 08-3301-2, UDI/DI 00840861101757, Lot Numbers: 26AXAC052; 5) 13-2201-5, UDI/DI 00840861101849, Lot Numbers: 26AXAC062, 26AXAC064; 6) 13-2251-0, UDI/DI 00840861101863, Lot Numbers: 26AXAC041, 26AXAC058, 26AXAC059, 26AXAC065, 26BXAC001, 26BXAC003, 26BXAC005, 26BXAC034, 26BXAC049, 26BXAC051; 7) 13-3251-9, UDI/DI 00840861101887, Lot Numbers: 26BXAC037, 26BXAC048. Distribution: Worldwide distribution - US Nationwide and the country of Mexico. Affected quantity: 2,998 cs; 68 ea
Hazard: Complaints of blue-green discoloration in product

3 products in this recall

GRANUFLO, NaturaLyte and Citrasate recalled for blue-green discoloration

Fresenius Medical Care is recalling three dialysis acid concentrate products, GRANUFLO, NaturaLyte and Citrasate, after complaints of blue-green discoloration in the product. No injuries have been reported. The products were distributed nationwide in the US and in Mexico.

The agency lists each product separately. Check every one you might have.

GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for Bicarbonate Hemodialysis
Z-3091-2026 · 27,216 cs; 2,316 ea
NaturaLyte, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-1251-1, 08-2251-0, 08-2301-3, 08-3251-9, 08-3301-2, 13-2201-5, 13-225… (this page)
Z-3092-2026 · 2,998 cs; 68 ea
Citrasate, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-2251-CA, 08-3251-CA, 13-2251-CA; Liquid Acid Concentrate for Bicarbona…
Z-3093-2026 · 56,036 cs; 1,788 drums; 204 ea