CLASS II ONGOING Device recall · Reported 2 Jul 2025 · FDA Enforcement Report
Caphosol Artificial Saliva (32 doses sachet box) recalled
Recordati Rare Diseases is recalling Caphosol Artificial Saliva (32 doses sachet box), distributed nationwide in the US. The recall was initiated on 11 Jun 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2012-2025
- FDA event ID
- 97007
- Recalling firm
- Recordati Rare Diseases, Bridgewater, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 Jun 2025
- FDA classified
- 23 Jun 2025
- Reported
- 2 Jul 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Device type
- Other Medical Devices
Timeline
| 11 Jun 2025 | Recall initiated by company | |
| 23 Jun 2025 | Classified by FDA | +12 days |
| 2 Jul 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Out of specification stability test result for the Caphosol B solution from process validation lots
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution (32 sachets Solution A Phosphate, 32 sachets Solution B Calcium)
Where it was distributed
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.
Questions about this recall
Why was it recalled?
Out of specification stability test result for the Caphosol B solution from process validation lots
Which lots are affected?
UDI-DI: 5060146293129. Lot Numbers: 001U002U, 001U002UA. Expiration 2026-10
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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