RECORDATI RARE DISEASES INC. recalls Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution…

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

Recordati Rare Diseases Inc. notified consignees on about 06/11/2025 via emailed letter. Consignees were instructed to examine inventory for affected lots, discontinue using, dispensing and distributing the affected lots, and promptly return any inventory. Consignees were also instructed to complete and return the Recall Response Form as well as notify consignees if the affected lots were further distributed.

• FDA enforcement recordOfficial FDA database entry for Z-2012-2025
• FDA 510(k) clearance · K234015The device's official FDA premarket clearance record
• FDA device classification · LFDOfficial FDA classification for this device type
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find RECORDATI RARE DISEASES INC.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.