Caphosol Artificial Saliva sachets recalled for out-of-specification stability
Recordati Rare Diseases is recalling Caphosol Artificial Saliva 32-dose sachets because stability test results for Solution B were out of specification during process validation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving an out-of-specification test result during process validation. The source text does not report any illnesses, injuries, or confirmed product failures, making this a precautionary measure based on a manufacturing control finding rather than an acute safety event.
Plain-English summary
Recordati Rare Diseases Inc. is recalling Caphosol Artificial Saliva (32 doses sachet box) containing 64 x 15 mL sachets of aqueous solution (32 sachets Solution A Phosphate and 32 sachets Solution B Calcium). The recall was initiated because stability test results for the Caphosol B solution from process validation lots were out of specification.
The recalled product has UDI-DI 5060146293129 and lot numbers 001U002U and 001U002UA with expiration date October 2026. A total of 3,754 boxes (120,128 doses) were distributed.
The recalled product was distributed nationwide in the United States in Georgia, Ohio, Tennessee, Texas, and Virginia, as well as internationally in Germany, France, Italy, Portugal, Spain, Sweden, and the United Kingdom. Consumers who have this product should contact their healthcare provider or Recordati Rare Diseases Inc. for instructions on what to do with their product.
The recalled product
- 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)
- Manufacturer
- RECORDATI RARE DISEASES INC.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI: 5060146293129. Lot Numbers: 001U002U
- 001U002UA. Expiration 2026-10
Distribution
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