Z-2012-2025Class II

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

Name: Z-2012-2025 Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution (32 sachets Solution A...
Creator: Recordati Rare Diseases Inc.
Published: 2025-06-11
License: https://open.fda.gov/license/

Recordati Rare Diseases Inc. / initiated 2025-06-11 / Open, Classified / root cause: design

FDA source

RECORDATI RARE DISEASES INC. began a recall of Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution (32 sachets Solution A Phosphate, 32 sachets Solution B Calcium) on 2025-06-11. FDA classified it as Class II and gives the reason as "Out of specification stability test result for the Caphosol B solution from process validation lots". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2012-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-06-11
Posted: 2025-06-23
Recalling firm: Recordati Rare Diseases Inc.
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)
Product code: LFD Saliva, Artificial
Reason for recall: Out of specification stability test result for the Caphosol B solution from process validation lots
Root cause tag: design
FDA root cause: Device Design
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.
Quantity in commerce: 3,754 boxes (120,128 doses)
Distribution: 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.
Product codes and lots: UDI-DI: 5060146293129. Lot Numbers: 001U002U, 001U002UA. Expiration 2026-10

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2012-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2012-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-02	2025-06-23

Product code LFD

K234015UnclassifiedCaphosol® Artifical Saliva (32 doses sachet box)Eusa Pharma (Uk) Limited / cleared 2024-03-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)