Caphosol Artificial Saliva Recalled for Stability Test Failure

Agency Publication Date: June 23, 2025

Summary

RECORDATI RARE DISEASES INC. is recalling 3,754 boxes (120,128 doses) of Caphosol Artificial Saliva because Solution B in the kit failed a stability test during validation. Each box contains 64 individual sachets—32 of Solution A (Phosphate) and 32 of Solution B (Calcium)—which are intended to be mixed together for the treatment of dry mouth. There have been no reported incidents or injuries related to this issue to date.

Risk

The stability test failure indicates that Solution B may not meet chemical specifications over its shelf life, which could reduce the product's effectiveness or cause it to behave unpredictably during use.

What You Should Do

The recalled product is Caphosol Artificial Saliva (32 doses sachet box) with UDI-DI 5060146293129 and lot numbers 001U002U or 001U002UA with an expiration date of October 2026.
Identify if you have the affected product by checking the lot number printed on the sachet box or the individual sachets for codes 001U002U or 001U002UA.
Stop using the recalled product immediately.
Return the product to the place of purchase for a refund or replacement, throw it away, or contact your healthcare provider or Recordati Rare Diseases Inc. for further instructions.
Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider, or return the product to the place of purchase for a refund or replacement

Option 2: Dispose of Product

How to: Stop using and throw the product away.

Affected Products

Product: Caphosol Artificial Saliva (32 doses sachet box)

Variants: 64 x 15 mL sachets, 32 sachets Solution A Phosphate, 32 sachets Solution B Calcium

Lot Numbers:

001U002U (Exp 2026-10)

001U002UA (Exp 2026-10)

UDI:

5060146293129

Recall #: Z-2012-2025. Out of specification stability test result for the Caphosol B solution from process validation lots.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97007

Status: Active

Manufacturer: RECORDATI RARE DISEASES INC.

Manufactured In: United States

Units Affected: 3,754 boxes (120,128 doses)

Distributed To: Georgia, Ohio, Tennessee, Texas, Virginia

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

The recalled product is Caphosol Artificial Saliva (32 doses sachet box) with UDI-DI 5060146293129 and lot numbers 001U002U or 001U002UA with an expiration date of October 2026.

Identify if you have the affected product by checking the lot number printed on the sachet box or the individual sachets for codes 001U002U or 001U002UA.

Stop using the recalled product immediately.

Return the product to the place of purchase for a refund or replacement, throw it away, or contact your healthcare provider or Recordati Rare Diseases Inc. for further instructions.

Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this recall.