Caphosol Artificial Saliva — Class II medical device recall Z-2012-2025
Ongoing recall by RECORDATI RARE DISEASES INC., reported 2025-07-02, distributed nationwide. Out of specification stability test result for the Caphosol B solution from process validation lots
| Recall number | Z-2012-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | RECORDATI RARE DISEASES INC., Bridgewater, NJ, United States |
| Recall initiated | 2025-06-11 |
| Classified | 2025-06-23 |
| Reported by FDA | 2025-07-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | DE, ES, FR, GB, IT, PT, SE |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 05060146293129 |
| Lot numbers | 001U002U, 001U002UA, 2026-10 |
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)
Reason for recall
Out of specification stability test result for the Caphosol B solution from process validation lots
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2012-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.