Class II — Potential Health Hazard

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

Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 Recalled by RECORDATI RARE DISEASES INC. Due to Out of specification stability test result for the...

Date: June 11, 2025
Company: RECORDATI RARE DISEASES 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 RECORDATI RARE DISEASES INC. directly.

Affected Products

Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution (32 sachets Solution A Phosphate, 32 sachets Solution B Calcium)

Quantity: 3,754 boxes (120,128 doses)

Why Was This Recalled?

Out of specification stability test result for the Caphosol B solution from process validation lots

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About RECORDATI RARE DISEASES INC.

RECORDATI RARE DISEASES INC. has 1 total recall tracked by RecallDetector.

Related Recalls

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