Medications & Supplements/Prescription Drugs

Dexonto 0.4% Solution Recalled for Incorrect Expiration Date on Outer Box

Agency Publication Date: April 28, 2025

Summary

Nubratori, Inc. is recalling 20 boxes of Dexonto 0.4% (dexamethasone sodium phosphate) solution 20 mg/5 mL because the outer packaging incorrectly lists the expiration date (Beyond Use Date) as December 25, 2025. While the individual vials inside are correctly labeled with an expiration date of December 25, 2024, the error on the box could lead users to keep the medication longer than its safe shelf life. Using the product after its true expiration could mean it is no longer effective or safe for treatment.

Risk

Using this medication after its actual expiration date of December 25, 2024, may result in reduced potency or degradation of the drug, which can impact the effectiveness of the intended treatment. No injuries or adverse events have been reported to date.

What You Should Do

This recall involves 20 boxes of Dexonto 0.4% (dexamethasone sodium phosphate) solution 20 mg/5 mL (4 mg/mL) with lot number C04292401X1.
To identify if your product is affected, check the outer box for NDC 71300-6564-1 and lot number C04292401X1. The recalled boxes are incorrectly marked with a Beyond Use Date (BUD) of 12/25/2025, even though the vials inside (NDC 71300-6564-3) correctly show 12/25/2024.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Nubratori, Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Dexonto 0.4% (dexamethasone sodium phosphate) solution 20 mg/5 mL (4 mg/mL)

Variants: 20 mg/5 mL (4 mg/mL), Rx Only, 12 - 5 mL Single Dose Units per box, Preservative Free, Non-Sterile Product, For Iontophoresis Use Only, Not for Injection

Lot Numbers:

C04292401X1 (BUD: 12/25/2025 on box)

NDC:

71300-6564-1

71300-6564-3

Individual vials are labeled correctly (BUD 12/25/2024); only the outer boxes are incorrect.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96699

Status: Active

Manufacturer: Nubratori, Inc

Sold By: Authorized distributors; Retail pharmacies

Manufactured In: United States

Units Affected: 20 boxes

Distributed To: Pennsylvania, California

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

This recall involves 20 boxes of Dexonto 0.4% (dexamethasone sodium phosphate) solution 20 mg/5 mL (4 mg/mL) with lot number C04292401X1.

To identify if your product is affected, check the outer box for NDC 71300-6564-1 and lot number C04292401X1. The recalled boxes are incorrectly marked with a Beyond Use Date (BUD) of 12/25/2025, even though the vials inside (NDC 71300-6564-3) correctly show 12/25/2024.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Nubratori, Inc. for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Dexonto 0.4% (dexamethasone sodium phosphate) solution 20 mg/5 mL (4 mg/mL)

Variants: 20 mg/5 mL (4 mg/mL), Rx Only, 12 - 5 mL Single Dose Units per box, Preservative Free, Non-Sterile Product, For Iontophoresis Use Only, Not for Injection

Lot Numbers:

C04292401X1 (BUD: 12/25/2025 on box)

NDC:

71300-6564-1

71300-6564-3

Individual vials are labeled correctly (BUD 12/25/2024); only the outer boxes are incorrect.