Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

MedicaLyte Liquid Bicarbonate Concentrate. Model Numbers: BC+201 (45X) Recalled by Nipro Renal Soultions USA, Corporation Due to Potential for the presence of visible foreign matter.

Date: April 11, 2025
Company: Nipro Renal Soultions USA, Corporation
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 Nipro Renal Soultions USA, Corporation directly.

Affected Products

MedicaLyte Liquid Bicarbonate Concentrate. Model Numbers: BC+201 (45X), BC+100 36.83X. Plastic bottle packaged in corrugated shipper cases (4 bottles per shipper case).

Quantity: 816,840 units (BC+201), 39,228 units (BC+100)

Why Was This Recalled?

Potential for the presence of visible foreign matter.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Nipro Renal Soultions USA, Corporation

Nipro Renal Soultions USA, Corporation has 2 total recalls tracked by RecallDetector.

Related Recalls

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