Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

NaturaLyte Liquid Acid concentrate Recalled by Fresenius Medical Care Holdings, Inc. Due to The "Nominal Chemical Composition" section of the label...

Date: October 4, 2022
Company: Fresenius Medical Care Holdings, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Fresenius Medical Care Holdings, Inc. directly.

Affected Products

NaturaLyte Liquid Acid concentrate, Part Number 08-0231-4, four (4) one-gallon bottles per bottle case. For dialysis.

Quantity: 17700

Why Was This Recalled?

The "Nominal Chemical Composition" section of the label incorrectly lists 5.62g/L KCL (potassium chloride). 5.62g/L actually corresponds to the CaCl (calcium chloride) content. The product remains potassium free.

Where Was This Sold?

This product was distributed to 21 states: AL, AZ, CA, FL, GA, HI, IL, IN, MD, MI, MS, MO, NE, NJ, NY, OH, PA, SD, TX, VA, DC

Affected (21 states)Not affected

About Fresenius Medical Care Holdings, Inc.

Fresenius Medical Care Holdings, Inc. has 161 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report