Caphosol Artificial Saliva (Recordati) – Stability Test Concern (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution (32 sachets Solution A Phosphate, 32 sachets Solution B Calcium)
Brand
RECORDATI RARE DISEASES INC.
Lot Codes / Batch Numbers
UDI-DI: 5060146293129. Lot Numbers: 001U002U, 001U002UA. Expiration 2026-10
Products Sold
UDI-DI: 5060146293129. Lot Numbers: 001U002U, 001U002UA. Expiration 2026-10
RECORDATI RARE DISEASES INC. is recalling Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution (32 sachets So due to Out of specification stability test result for the Caphosol B solution from process validation lots. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Out of specification stability test result for the Caphosol B solution from process validation lots
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026