FDA Device recall Z-2012-2025
Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution (32 sachets Solution A Phosphate, 32 sachets Solution…
- FDA Device
- Class II
- ongoing
- Published 2025-07-02
On 2025-07-02 the FDA classified a Class II recall of Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution (32 sachets Solution A Phosphate, 32 sachets Solution… by Recordati Rare Diseases, citing out of specification stability test result for the Caphosol B solution from process validation lots.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2012-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-06-11 |
| Published | 2025-07-02 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Recordati Rare Diseases |
| Distribution | US |
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
Out of specification stability test result for the Caphosol B solution from process validation lots
Identifiers
| code_info | UDI-DI: 5060146293129. Lot Numbers: 001U002U, 001U002UA. Expiration 2026-10 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2012-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.