Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution (32 sachets Solution A Phosphate, 32 sachets Solution B Calcium)
FDA Recall Z-2012-2025 · Posted 2025-06-23
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Recalling FirmRECORDATI RARE DISEASES INC.
Recall StatusOpen, Classified
Product CodeLFD
Date Initiated2025-06-11
Product Quantity3,754 boxes (120,128 doses)
Reason for Recall
Out of specification stability test result for the Caphosol B solution from process validation lots
Firm Action
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.
Root Cause
Device Design
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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