Caphosol Artificial Saliva recall
Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution (32 sachets Solution A Phosphate, 32 sachets Solution B Calcium)
Why was Caphosol Artificial Saliva recalled?
Out of specification stability test result for the Caphosol B solution from process validation lots
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 5060146293129. Lot Numbers: 001U002U, 001U002UA. Expiration 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)
- Recalling firm
- RECORDATI RARE DISEASES INC.
- Quantity
- 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.
- Recall date
- July 2, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)