Dexonto 0.4% Dexamethasone Solution Recalled for Incorrect Expiration Dating
Nubratori, Inc. is recalling Dexonto 0.4% dexamethasone sodium phosphate solution because some outer boxes are labeled with an incorrect expiration date (12/25/2025 instead of 12/25/2024), creating risk of use after actual expiration.
What this means for you
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 with a labeling error (incorrect expiration date). The source text does not report any illnesses or injuries, and the hazard is a labeling discrepancy rather than contamination or structural defect. This meets the Moderate criteria for labeling errors.
Plain-English summary
Nubratori, Inc. is recalling Dexonto 0.4% (dexamethasone sodium phosphate) solution 20 mg/5 mL (4 mg/mL) due to incorrect labeling on outer boxes. Individual vials are labeled correctly with a beyond-use date (BUD) of 12/25/2024; however, some outer boxes are labeled with an incorrect BUD of 12/25/2025.
This labeling discrepancy creates the potential for the product to be used after its actual expiration date, which could result in loss of product efficacy. The affected product includes lot #C04292401X1 distributed to Pennsylvania and California.
If you have this product, do not use it beyond the correct expiration date of 12/25/2024. Check the individual vial labeling, not the outer box. Consult with your healthcare provider or pharmacist regarding any medication questions or concerns.
The recalled product
- 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)
- Manufacturer
- Nubratori, Inc
- Hazard
- mis-labeling
- expired-product-risk
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)
- Lot #: C04292401X1
- BUD: 12/25/2025 (box).
Distribution
Distributed in 2 states:
- CA
- PA
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