# FDA recall D-0392-2025

> **Nubratori, Inc** · Class II · drug recall initiated 2025-04-15.

## Product

Dexonto 0.4% (dexamethasone sodium phosphate) solution 20 mg/5 mL (4 mg/mL), Rx Only, 12 - 5 mL Single Dose Units per box, Preservative Free, For Iontophoresis Use Only, Non-Sterile Product, Not for Injection, NUBRATORI RX, 381 Van Ness Ave# 1507, CA 90501, NDC 71300-6564-1 (box), 71300-6564-3 (vial).

## Reason for recall

Labeling: Incorrect or Missing Lot and/or Expiration date: Individual vials of Dexonto 0.4%, are labeled correctly with the BUD of 12/25/2024, however, the outer box on some of the Dexonto 0.4% are labeled incorrectly with a BUD of 12/25/2025.

## Distribution

PA and CA.

## Key facts

- **Recall number:** D-0392-2025
- **Recalling firm:** Nubratori, Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-04-15
- **Report date:** 2025-05-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Torrance, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0392-2025

## Citation

> AI Analytics. FDA recall D-0392-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0392-2025. Source: US FDA. Licensed CC0.

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