RECORDATI RARE DISEASES INC.: Medical Device Recall in 2025 - (Recall #: Z-2012-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: June 11, 2025

Date Posted: July 2, 2025

Recall Number: Z-2012-2025

Event ID: 97007

Reason for Recall:

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

Status: Ongoing

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

Code Information:

UDI-DI: 5060146293129. Lot Numbers: 001U002U, 001U002UA. Expiration 2026-10

Distribution Pattern:

Worldwide - US Nationwide distribution in the states of GA, OH, TN, TX, VA and the countries of Germany, France, Italy, Portugal, Spain, Sweden, United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated