Recordati recalls Caphosol Artificial Saliva (32-dose sachet boxes) due to stability test failures in solution components. Affected lots expired by 2026-10. No remedy specified in recall notice.
Out of specification stability test result for the Caphosol B solution from process validation lots
Recordati is recalling Caphosol Artificial Saliva (32-dose sachet boxes) because stability tests showed the product's solution components failed quality checks. This means the product may not be safe for use as intended, though the recall doesn't specify immediate risks or actions.
The recall states that stability test results for Caphosol B solution from process validation lots were out of specification. This means the product may not maintain its intended quality over time, potentially affecting safety or effectiveness.
People who own or use Caphosol Artificial Saliva (32-dose sachet boxes) with lot numbers 001U002U or 001U002UA, which expired by October 2026. Those with the product are most at risk.
Check for Caphosol Artificial Saliva (32-dose sachet boxes) with lot numbers 001U002U or 001U002UA. The product expires by October 2026 and has a unique identifier 5060146293129.
Look for lot numbers 001U002U or 001U002UA on the packaging, which expire by October 2026.
The recall states stability test results were out of specification, but the notice doesn't specify immediate safety risks or injuries.
The recall notice doesn't specify any remedy or action steps for affected products.
Check for Caphosol Artificial Saliva (32-dose sachet boxes) with lot numbers 001U002U or 001U002UA, which expire by October 2026.
We’ve drafted a message you can send Recordati Rare Diseases Inc. to request your refund or repair — edit it as you like.
Subject: Recall Z-2012-2025 — Recordati Rare Diseases Inc. Recordati Rare Diseases Inc. Hello, I own a Recordati Rare Diseases Inc. that is covered by recall Z-2012-2025 from Recordati Rare Diseases Inc.. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
