CLASS II ONGOING Drug recall · Reported 7 May 2025 · FDA Enforcement Report
Dexonto 0.4% (dexamethasone sodium phosphate) solution recalled
Nubratori is recalling Dexonto 0.4% (dexamethasone sodium phosphate) solution 20 mg/ (4 mg/mL), distributed in California, Pennsylvania. The recall was initiated on 15 Apr 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0392-2025
- FDA event ID
- 96699
- Recalling firm
- Nubratori, Torrance, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 15 Apr 2025
- FDA classified
- 28 Apr 2025
- Reported
- 7 May 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Injectable & IV Drugs
Timeline
| 15 Apr 2025 | Recall initiated by company | |
| 28 Apr 2025 | Classified by FDA | +13 days |
| 7 May 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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).
Where it was distributed
PA and CA.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot #: C04292401X1, BUD: 12/25/2025 (box).
Where was it sold?
PA and CA.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.